Running Head: PATHWAYS TO RECOVERY WORKBOOK FORMAT 1

Usefulness of the Pathways to Recovery:

a Strengths Recovery Self-Help Workbook Format

Joanna M. McCloud

Emporia State University

PATHWAYS TO RECOVERY WORKBOOK FORMAT 2

Abstract

This document is a research proposal for determining the usefulness of the format of the

Pathways to Recovery: a Strengths Recovery Self-Help Workbook, for updating the book in the

future. It is published by the School of Social Welfare at the University of Kansas and is

distributed free to Kansas mental health agencies, advocacy groups and individual “consumers”.

Consumers are persons who suffer the effects of mental illness, such as depression and bi-polar

disorder and seek help in their recovery. The workbook is used by practitioners and consumers

individually and in groups. A survey will be mailed to each practitioner (case manager) and all

consumers from Kansas mental health agencies, advocacy groups, and consumer-run

organizations, who want to participate. Practitioners will send completed surveys using a self-

address, stamped envelope provided them, to me at the University of Kansas. Survey data will

be entered into SPSS 17 statistics software in order to generate qualitative results useful to the

Pathways to Recovery Project in updating the book in the future.

PATHWAYS TO RECOVERY WORKBOOK FORMAT 3

Usefulness of the Pathways to Recovery: a Strengths Recovery Self-Help Workbook Format

Introduction

This document is a research proposal for determining the usefulness of the format and

content of the Pathways to Recovery: a Strengths Recovery Self-Help Workbook, for updating the

book in the future. It is published by the School of Social Welfare at the University of Kansas

and is distributed free to Kansas mental health agencies, advocacy groups and individual

“consumers”, those persons who suffer the effects of mental illness and seek help in their

recovery. Assistance and the Pathways book are available to them through local mental health

agencies and advocacy groups, as well as consumer-run organizations. The workbook is used by

practitioners and consumers individually and in groups. Consumers are typically diagnosed with

depression, borderline personality disorders, and other maladies.

Research Questions

The following questions have been used to develop the research design based on survey

research methodology:

1. What are the demographics of consumers/users?

2. Do consumers prefer using a hardback or paperback version?

3. Are the font, type size, and color appealing?

4. Is the reading level appropriate for users?

5. Is the material divided into sensible chapters?

6. Do practitioners change the order of the chapters to best meet the needs of their

groups?

7. Is the material considered current?

8. Are the supplemental readings adequate?

PATHWAYS TO RECOVERY WORKBOOK FORMAT 4

9. Are other formats such as Braille, audio book, or downloadable versions needed?

10. Is there sufficient writing space provided for module exercises?

11. Would a self-check be helpful at the end of each chapter?

12 Would 3 months, 6 months and 1 year self-checks be helpful?

13. Would a glossary helpful?

Literature Review

The printed workbook format can effectively communicate helpful information regarding

health concerns to users. Newton (2001) found that the use of a printed workbook providing

menopausal women with information about hormone replacement treatments helps them make

better decisions about the direction of their health care. In a study of 580 women who read, “To

Be or Not to Be on Hormone Replacement Therapy: a Workbook to Help You Explore Your

Options,” participants felt more confident and informed about treatments available to them and

what they can do on their own to ensure good health during mid-life. The Pathways workbook

includes up-to-date therapies available for various mental health disorders and promotes self-

care. Through this research, practitioners will be giving their opinions on the quality of therapies

featured and the format in which they are presented.

Paterson et al. (2001) asserts in their article, Using Disease Risk Estimates to Guide Risk

Factor Interventions: Field Test of a Patient Workbook for Self-Assessing Coronary Risk that a

workbook is more successful for users when self-assessment components are included at the end

of each module. Many adult patients who read Heartcheck (the workbook used in this study) to

learn more about factors that contribute to coronary problems, apply the information to improve

their health. At the end of each module is a self-test that allows patients to check their

understanding of concepts contained in that section. Pathways users learn preventative actions

PATHWAYS TO RECOVERY WORKBOOK FORMAT 5

they can take to avoid crisis relapses. It is important to learn if the self-assessment exercises are

effective and if consumers continue to use their knowledge gained through using the workbook.

Feedback is an essential element necessary for passive training techniques, such as a

workbook, to be effective. In an article reporting research done by Burke et.al. (2006) entitled,

Relative Effectiveness of Worker Safety and Health Training Methods, it is stated that

“Behavioral modeling involves…practice, and feedback designed to modify behavior” (p. 315).

Burke’s group found that workers using a self-help workbook to improve their safety on the job,

the opportunity in small groups for feedback and practice are a necessity. A number of Kansas

mental health agencies offer Pathways groups with activities and mentoring for workbook users.

This study will provide information from practitioners regarding the usefulness of the workbook

in their groups and what the practitioners see in long-term recovery of individual consumers.

The literature review covers three areas: the influence of self-help material for mental

health consumers/patients; the inclusion of self-assessment strategies in the workbook content to

measure the learning of concepts; and feedback as an essential component of the workbook

format for successful outcomes. These three articles are important resources to use in

determining a successful approach to self-education if using a workbook as the main method of

communication with users. Up-to-date therapies available and promotion of self-care are

essential components. Practice and feedback in group settings are also helpful in retaining the

material. The Pathways workbook is designed to keep users informed of the latest philosophies

concerning mental health recovery and provides a self-care plan that is adaptable to each

person’s needs. The workbook can be used in a group or by individuals, if they feel more

comfortable working through the exercises on their own. This study will produce feedback that

PATHWAYS TO RECOVERY WORKBOOK FORMAT 6

can be compared to the results discussed in the articles and direct the authors of the workbook in

writing updates.

Methodology and Research Design

Since 2002, when the workbook was first printed, the School of Social Welfare has

distributed almost two thousand copies state-wide. There have been two attempts so far to

contact practitioners and consumers regarding the usefulness of the book format. These have

been by telephone, and which have not been successful. Practitioners are reluctant to take time

from their duties because there is pressure to produce “billable hours”. Consumers have been

uncomfortable being interviewed and prefer to participate using something that can be completed

on their own. A survey will be used to acquire qualitative data for both groups, taking into

account that practitioners would not have time for a research interviews with the researcher and

also that consumers prefer a survey over an interview. Survey research techniques will be used

to acquire qualitative data from both groups.

Research Design.

After receiving approval by the KUMC Human Subjects Committee regarding the

“Application for Expedited Review of Human Subject Research” (Appendix A), I will consult

the list of potential Kansas subjects (Appendix B). There are 21 mental health agencies, eight

advocacy groups, and 22 consumer-run organizations who will be contacted. A cover letter,

consent form and survey will be sent to approximately 800 Kansas consumers who are currently

using the Pathways workbook and 35 Kansas practitioners who conduct Pathways groups. Each

group to be studied will have a survey written specifically for them. The consent form is

Appendix D. A copy of the cover letter and survey for practitioners can be seen as Appendix E

and the same for consumers is found as Appendix F.

PATHWAYS TO RECOVERY WORKBOOK FORMAT 7

Population and Setting.

The subjects of this study are mental health practitioners at Kansas mental health

agencies and advocacy groups, as well as individual consumers who seek services at these

agencies and groups. All active practitioners and consumers will be eligible because I want to

reach as many subjects as possible.

Data Collection.

I will send a flyer (Appendix C) to each agency and group announcing the project and

follow up with a telephone call to find out the approximate number of expected participants.

Data will be collected using two surveys, one for practitioners (Appendix F) and one for

consumers (Appendix H). Both surveys have three sections specific to each group: Appearance

of the Book, Book Content, and Workbook Versions. Questions included in the Appearance of

the Book, will focus on the cover, typography and illustrations. Book Content has questions

regarding the reading level, subject matter and exercises. Workbook Versions covers the need

for digital, Braille and audio book formats.

Surveys with a cover letter (Appendix E for practitioners and Appendix G for consumers)

will be sent to participating mental health agencies, advocacy groups and consumer-run

organizations. A contact person at each location will distribute the consent forms, cover letters

and surveys and then collect them once they have been completed. These will be returned to me

in self-addressed, stamped envelopes that I provide.

Data Analysis.

The data will be analyzed using SPSS 17 statistics software. There will be one file for

practitioners and one for consumers. Each research participant will be given their own record.

The answer to each question will be entered into the database. Once all of the information has

PATHWAYS TO RECOVERY WORKBOOK FORMAT 8

been entered, reports will be generated for each group, giving qualitative outcomes for the format

of the book. I will be measuring the usefulness of the book’s format and the satisfaction of the

book’s content for practitioners and consumers by looking at results for quality of the book

format, appearance and ease of use.

Role of the Researcher and Review Board

As the sole researcher, I will responsible for the development of the surveys, mail copies

of them to participants, enter the data into the computer when surveys are returned, review the

findings, and make suggestions to the Pathways Project Coordinator for any modifications that

will increase the usefulness of the workbook. The form, “Application for Expedited Review of

Human Subject Research” will be submitted to the KUMC Human Subjects Committee for

approval of the study.

Time Schedule and Budget

Expected Schedule From To Activity Reference Jan. 5, 2011

Jan. 7, 2011

1. Complete and submit the “Application for Expedited Review of Human Subject Research” to KUMC.

1. Appendix A

Feb. 15, 2011

Mar. 15, 2011

1. Mail promotional flyers. 2. Telephone contact with potential subjects. 3. Mail consent forms, cover letters, and surveys to subjects.

1. Appendix C 2. Appendix B 3. Appendices D-H

Mar. 20, 2011

Apr. 30, 2011

1. Consent forms and surveys are completed and returned to me in self-addressed, postage- paid, envelopes provided by me.

May 1, 2011

May 31, 2011

1. Late submissions accepted.

June 1, 2011

June 15, 2011

1. Data is entered into an SPSS 17 file designated for practitioners and one for consumers. Each record will reflect questions from the survey.

June 15, 2011

July 15, 2011

1. Reports generated and analyzed for usefulness of the workbook.

Aug. 1, Aug. 5, 1. Suggestions reflecting the outcome of the

PATHWAYS TO RECOVERY WORKBOOK FORMAT 9

2011 2011 study will be made to the Pathways Project Coordinator.

Budget

Item Cost

My salary (as part of current job)

$8,960

Photocopies $160

Envelopes $240

Postage $880

Telephone charges $520

Total $10,760

Limitations of the Study

This study is exploratory and will serve as a good evaluation of the usefulness of the

Pathways book format, but the topic of this study should be revisited again in the future to

determine if needs are changing either for the practitioners or the consumers. This study will not

measure the effectiveness of the recovery modules, nor will it determine a success rate of those

users who have completed the workbook and are no longer using it as a reference. It will not be

possible to observe the participants taking the survey due to the limited conditions under which

the research must be done. In the past, there have been consumers who agreed to complete a

survey for the School of Social Welfare, but then asked someone else to take it for them. I am

hoping that Pathways users will be the ones actually completing the survey and that the length of

the consumer survey will not be a deterrent. Also, with lengthy surveys (more than three pages)

consumers have gotten tired and begun to circle entire sections instead of answering individual

PATHWAYS TO RECOVERY WORKBOOK FORMAT 10

questions. Another concern is the percentage of participants who do not return their surveys for

analysis, although I am allowing extra time for late submissions.

PATHWAYS TO RECOVERY WORKBOOK FORMAT 11

References

Burke, M. J., Sarpy, S.A., Smith-Crowe, K., Chan-Serafin, S., Salvador, R.O., Islam, G. (2006). Relative effectiveness of worker safety and health training methods. American Journal of Public Health , 96(2), 315-324.

Newton, K.M., LaCroix, A.Z., Buist, D. S., Delaney, K.M, Anderson, L.

(2001). Women's response to a mailed hormone replacement therapy workbook. Menopause , 8(5), 361-367.

Paterson, J .M., Llewellyn-Thomas, H.A., Naylor, C.D. (2001). Using disease

risk estimates to guide risk factor interventions: field test of a patient workbook for self-assessing coronary risk. Health Expectations , 5 , 3-15.

Ridway, P., McDiarmid, D., Davidson, L., Bayes, J ., Ratzlaff S. (2002).

Pathways to recovery: a strengths recovery self-help workbook . Lawrence, KS: Minuteman Press.

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THIS FORM CAN BE FOUND AT THE FOLLOWING LINK: http://www2.kumc.edu/researchcompliance/hscforms.htm

I. STUDY INFORMATION Principal Investigator: Joanna McCloud Department: School of Social Welfare Email: chacha73@ku.edu Phone: 864-3776 Mail Stop: Main Alternate Contact Person (e.g., Project Coordinator): Email: Phone: Mail Stop: Protocol Title: Usefulness of "Pathways to Recovery" Workbook Protocol Number, Version and/or Date: January 5 - August 5, 2011

II. Expedited Classification Indicate, by checking the appropriate space(s), the category or categories which may apply to your research. NOTE: The HSC will conclusively determine whether or not your research can be appropriately reviewed using an expedited review procedure. If your research is not within one of the following seven (7) categories, stop here and instead complete either the Application for Full Committee Review or Application for Exempt Review.

(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

KUMC HUMAN SUBJECTS COMMITTEE

APPLICATION FOR EXPEDITED REVIEW OF HUMAN SUBJECT RESEARCH

*THIS FORM MUST BE TYPED*

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(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

(3) Prospective collection of biological specimens for research purposes by noninvasive means.

(a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need

for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated

by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or

during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection

procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;

(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;

(j) sputum collected after saline mist nebulization. (k) other:

(4) Collection of data through noninvasive procedures (not involving general anesthesia or

sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

(a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy;

(b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of

naturally occurring radioactivity, electroretinography, ultrasound, diagnostic

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infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment,

and flexibility testing where appropriate given the age, weight, and health of the individual

(f) other:

(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). NOTE: If all the records or specimens are in existence as of today’s date, do not use this form. Please submit the application specific to Retrospective Research posted at: http://www2.kumc.edu/researchcompliance/hscforms.htm

(6) Collection of data from voice, video, digital, or image recordings made for research purposes.

(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt).

III. Study Personnel List the study team members. In order for a research project to be approved, all members of the study team must demonstrate current training in human subjects protection. Study personnel also must have on file a current conflict of interest disclosure. Name Department Role (PI, Co-I,

Coordinator, etc.) Responsibilities (see a – n below)

Joanna McCloud Social Welfare Researcher K Please use corresponding letters for responsibilities. If not listed, record responsibility in box. a. Conduct Informed consent interview h Take vital signs, height, weight b. Complete physical examination i. Review/sign laboratory reports

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c. Obtain medical/surgical history j. Draw/collect laboratory specimens d. Complete source documents k. Perform tests, procedures, interventions, questionnaires e. Complete study data forms l. Dispense/collect study medication f. Assess unanticipated problems m. Complete drug accountability forms g. Review concomitant medications n. Manage study database IV. Location of the Study (a) Is this a multi-site study?

No Yes

(b) Will the KUMC principal investigator oversee or coordinate the research being

conducted at non-KUMC sites?

No Yes (Complete items (d) and (e) below)

(c) Check all study locations under the KUMC principal investigator’s responsibility:

Outpatient Clinics and Research Centers KUMC – 3901 Rainbow campus KUMC – Overland Park clinic General Clinical Research Center (GCRC) Landon Center on Aging Hoglund Brain Imaging Center KU Lawrence campus clinic Other clinic or research center KS mental health agencies and consumer run

organizations

Inpatient Setting University of Kansas Hospital (select one below)

Hospital nurses will provide only standard nursing care Hospital nurses will provide nursing services beyond standard care (Complete the Supplemental Nursing Impact Form)

Other Hospital

Classroom setting KUMC campus-Kansas City KU Lawrence campus Other universities/Colleges Elementary/Secondary Schools

International sites Other

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(d) In what states will the KUMC principal investigator conduct the study? (Check all that apply)

Kansas Missouri Other states: Specify (e) Provide details below on all non-KUMC study locations for which the KUMC principal

investigator is responsible:

(f) If the KUMC principal investigator is responsible for study conduct at non-KUMC study

locations, the HSC must ensure adequate plans for overall management of the study. Describe the investigator’s oversight plans, including how the investigator will ensure adherence to the study protocol, obtain informed consent, secure and maintain IRB approval at the other sites, obtain IRB approvals prior to implementing changes to the protocol, monitor adverse events or other unanticipated problems, and ensure general coordination of study conduct.

Investigator is responsible for maintaining contact with mental health agencies, consumer run organizations and advocacy groups. Surveys will be sent to these groups for completion by pratictioners and consumers using the Pathways to Recovery workbook as to usefulness of content and appearance. Instructions for completing the survey, a consent form, and survey will be in a packet given to each participant. Completed surveys will be turned in to a designated person at each location who will then return them to the investigator using the U.S. Mail or via fax. Unforeseen difficulties, any changes to protocol and the general coordination of the study will be overseen by the investigator.

V. Funding Information Please indicate funding source. Note: Federal regulations require the Human Subjects Committee to review the complete grant application. (a) UNFUNDED: Check this box only if there will be no funding source for this project. (b) FUNDED

Name of the Facility Primary Contact Name The site has its own IRB

IRB approval status at the site

See attachment Appendix B

Yes No

Yes No Yes No Yes No Yes No Yes No Yes No

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KUPI Funds KUEA Funds State Funds KUMC RI Funds: Grant # Pharmaceutical/Private Funds Federal Funds

(c) SEEKING FUNDING from (source) VI. Conflict of Interest

Please note that prior to HSC approval, an annual COI disclosure form must be on file for all KUMC study personnel. The following questions relate to the study named in this application. Principal investigators are responsible for addressing these questions on behalf of the study team. (a) Yes No Do any of the investigators or their immediate family (defined as

spouse, children, siblings, parents, equivalents by marriage [in- laws], or other household members) have financial arrangements with the sponsoring company or the products or services being

evaluated, including receipt of honoraria, income, or stock/stock options as payments in the past year or will be expected during the course of the project, that are not publicly traded, or whose value may be affected by the outcome of the research?

(b) Yes No Do any investigators, study personnel, or their immediate family listed on this application have consulting agreements, management

responsibilities, ownership interests, equity holdings or options (regardless of value) in the sponsoring company, the providers of the products or services being evaluated, vendors, provider(s) of goods, or subcontractors?

(c) Yes No Is any investigator, or their immediate family, a paid or unpaid

member of an advisory or executive board or have a paid or unpaid executive relationship with the sponsoring company or the providers of the products or services being evaluated?

(d) Yes No Do any investigators or their immediate family receive gift funds, educational grants, subsidies or other remuneration from the sponsoring company? (e) Yes No Do any investigators or their immediate family have an ownership or royalty interest in any intellectual property utilized in this protocol? (f) Yes No Does KUMC or the KUMC Research Institute have an ownership or royalty interest in any intellectual property utilized in this protocol?

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(g) If you answered “Yes” to any of the above, please describe in detail. Affirmative answers will be forwarded to the KUMC Conflict of Interest Committee.

VII. Project Information

Study Protocol: Submit with this application a research protocol that includes the following:

Purpose of the Research Background/Literature Review Hypotheses Specific Aims Subject Selection Criteria and Sample Size Justification Recruitment and Informed Consent Process (if applicable) Methods and Measurement Tools Statistical Analyses Data Security References

VIII. Subject Selection and Recruitment (a) How many subjects do you plan to enroll? 800 (b) Check all that apply to the target population for this study:

Healthy volunteers Adults 65 years and older Patients Comatose/traumatized Children/Minors (under 7 years of age) Terminally ill Children/Minors ( 7 - 17 years of age) Prisoners Pregnant women Persons w/ active psychiatric disease Cognitively impaired KUMC Employees Males only KUMC Students/Residents/Fellows Females only

(c) If vulnerable populations (such as children, pregnant women, cognitively impaired, etc.)

are being used, discuss the special protections being used to minimize risk of coercion or undue influence.

Practitioners will give the survey only to persons he/she deems appropriate.

(d) Explain how you will ensure that subject selection is equitable and that all relevant ethnic

groups, genders, and populations have access to the study.

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Subject selection will be available to both genders, any ethnicity, and populations seeking mental health services.

(e) Explain how you will be able to recruit the required number of subjects in a timely

manner.

The required number of subjects will be recruited by contacting a designated practioner who will then announce the survey at group meetings and post flyers.

(f) Are proposed ads, flyers, recruitment scripts, etc. included in the submission materials? (Submission at initial review is optional, but all recruitment materials must be HSC-approved prior to their use.)

Yes

No

(g) Will you be providing payment to subjects?

No

Yes Total amount:

*Payments must be described in the consent form

IX. Benefit/Risk Information (a) How will risks to participants be minimized? Address all relevant physical,

psychological, economic, social, or legal risks. Practitioners will screen potential subjects.

(b) Is there any information, data or specimens that are already being collected for diagnostic or treatment purposes that will be used for research purposes as well?

No.

(c) How are the risks to subjects reasonable in relation to the potential benefits?

Discuss both benefits that may accrue to the individual and those that may accrue to society.

Risks to the subjects are minimal. The benefits to the participating individuals and society as a whole will be a more refined workbook that effectively addresses the needs of users.

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X. Informed Consent Process (a) Specify the type of informed consent you propose to utilize in this research project.

Written Consent (Submit the consent form(s) with this application. If subjects are

children, provide a parental consent form with a youth assent form.)

Consent Forms Included with this Submission:

Adult Participant Surrogate Decision Maker Consent Parental Permission/Child Assent Withdrawal Follow-up Consent Genetic Testing Foreign language: Tissue repository Other:

Oral Consent or Consent without Signature (Waiver of Documentation of Consent) (If checked, indicate rationale below and submit the verbal consent script you intend to use. Please note that subjects could still receive a written statement regarding the research.)

Rationale for Requesting Waiver of Documentation of Consent A signed consent form would be the only record linking the subject and the

research, and the principal risk of a subject signing a consent form would be potential harm resulting from a breach of confidentiality.

The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.

Waiver of Consent Procedure (If checked, demonstrate that the research meets the

following four waiver criteria:) (b) How and by whom will initial contact with potential subjects take place?

The research involves no more than minimal risk to subjects.

The waiver will not adversely affect the rights and welfare of the subjects.

The research could not practicably be carried out without the waiver.

Whenever appropriate the subjects will be provided with additional pertinent information after participation.

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Joanna McCloud will telephone sites and coordinate process with practictioners. (c) Where and when will the consent interview take place?

At each location February 15 - March 15, 2011. (d) Describe the steps that will be taken to minimize the possibility of coercion or undue influence.

Practitioners are to emphasize that the survey is entirely on a volunteer basis and that all information given is confidential.

(e) What is(are) the primary language(s) of prospective subjects or their legally authorized representatives?

English. (f) What are the languages used by those obtaining consent?

English.

FOR ADULT STUDIES ONLY: (g) Will all adult subjects be able to consent for themselves?

Yes

No. It is expected that all subjects will need a surrogate decision-maker

No. It is expected that some subjects may need a surrogate decision-maker

If some subjects may need a surrogate decision-maker, how will study personnel assess the capacity of the subject to consent and to comprehend the consent?

If surrogate decision-makers are involved, do you plan to obtain written assent from subjects?

FOR PEDIATRIC STUDIES ONLY: (h) Will child subjects be capable of providing assent?

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Yes

No

If yes, how will you obtain assent?

At what age will you obtain assent? (i) Will any of the study subjects be foster children or wards of the State or other agency?

Yes

No

XI. Privacy and Confidentiality

(a) How will subjects be identified? (Check all that apply)

Selection during the course of usual clinical care

Chart reviews by persons involved in the patients’ care

Chart reviews by persons not involved in the patients’ care

Self-referral in response to HSC-approved ads or Web-sites

Referrals from outside physicians

Database searches; specify the database:

Other

(b) What measures will you take to protect privacy during the recruitment and consenting process?

Practitioners will address each group as a whole and subjects can consent to the process in private at a later time, if they want.

(c) What measures will you take to protect the privacy interests of subjects during the conduct of the study?

An envelope will enclose each survey. Only the name of the practitioner will be requested. Completed surveys can be turned in at any time convenient to the subject and the practitioner.

(d) How will you protect the confidentiality of data? Include information about where the data will be stored and persons who will have access to the data.

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The data is to be kept at each location inside an envelope that is kept in a secure place. All surveys returned to the investigator will be kept in a locked file drawer. Only the investigator has access to the data.

(e) Indicate whether or not a Certificate of Confidentiality will be obtained for this study. A Certificate of Confidentiality may be appropriate in studies where sensitive information

will be collected during the research (e.g., illicit drug use, illegal activities, genetic data, HIV status).

No Yes (If yes, provide a copy of the Certificate of Confidentiality.)

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XII. Child/Minor Studies Only

All studies involving children must undergo a separate risk assessment. Please indicate below your judgment of the research risks. Check one only.

The research does not involve greater than minimal risk. (45 CFR 46.404)

The research involves greater than minimal risk but presents the prospect of direct benefit to the individual subjects. (45 CFR 46.405)

The research involves greater than minimal risk and no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subjects’ disorder or condition. (45 CFR 46.406)

The research is not otherwise approvable but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. (45 CFR 46.407)

XIII. Cancer and Cancer-Related Studies

Does the proposed study relate to cancer or cancer prevention?

No

Yes

If yes, indicate study type below and use the Ancillary Form for PRMC Submissions. Cancer-related studies will be reviewed by the PRMC prior to the HSC review.

Therapeutic: Clinical trials with therapeutic intent using drugs, radiation,

surgery, and/or biological agents. Prevention: Clinical trials for the modulation of cancer risk and inhibition

of cancer progression using nutrition, dietary or chemoprevention interventions.

Screening, Early Detection, or diagnostic: Clinical trials directly testing the efficacy of devices, techniques, procedures or tests for earlier/more accurate detection or diagnosis of disease.

Supportive Care: Studies in which an intervention is used to improve the comfort and quality of life for the patient.

Epidemiologic/Observational: Studies among cancer patients and healthy populations that involved no intervention or alteration in the status of the participants e.g.; surveillance, risk assessment, environmental and behavioral studies etc.

Ancillary or Companion: Auxiliary studies that are stimulated by but not a required part of a main clinical trial/study, and that utilize patient or other resources of the main trial to generate information relevant to it. Companion or ancillary studies included must be linked to an active trial or epidemiologic or other observational study (screening, early detection, diagnostic, therapeutic; or prevention) and should include only patients accrued to that trial or study.

Correlative: Laboratory based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc.

As Principal Investigator,• I agree this application accurately reflects the proposed research plan.• I confirm that I have adequate time, assistance, equipment, support services, and finances

to safety conduct this study.• I accept responsibility for the scientific conduct of this study and for the rights and

welfare of human subjects.• I accept responsibility to ensure that all study personnel are adequately trained for their

role.• I agree to submit any amendments to the protocol or consent form to the HSC for

approval prior to implementation.• I agree to report any problems with the research, in accordance with university policy and

sponsor requirements.• I agree to maintain all required research records, including consent forms, during the

study. I recognize the authority of the HSC to inspect those records.• I agree to archive research records in accordance with the KUMC Records Retention

Policy.• I agree I will not commence research activities without final HSC approval (and full

executed contract, if applicable).

~c:2S;c2()/tJDate

Revised 5/15/08

Administrative Certification As Department Chair or Chair representative/Division Director/Dean/Executive Administrator/Center Director, I approve the submission of this proposal. The principal investigator is qualified, and adequate resources (in terms of time, assistance, equipment, support services and finances) are available to safely conduct the research. Method of Scientific Review (check all that apply)

The scientific review has already been accomplished:

The individuals/groups below have determined that the research uses procedures consistent with sound research design, which do not unnecessarily expose subjects to risk; the research is likely answer the proposed question; and the knowledge reasonably expected to result from the research has scientific importance.

NIH Other external review process: Specify GCRC Advisory Committee KUMC Departmental Review Committee* Department Chair/Director/Dean or a designee*

*Include a copy of the department scientific review checklist

The proposal is being referred for scientific review by:

Protocol Review and Monitoring Committee (cancer and cancer-related proposals) GCRC Advisory Committee

_______________________________________ ____________________ Signature Date _______________________________________ Type/Print Name

1

Appendix B

• Sites do not have their own IRB • IRB approval will be given at the site

Kansas Mental Health Agencies Name and Location of Facility Primary Contact Name

Area Mental Health Center - Garden City Kristy Guebara Area Mental Health Center - Dodge City James Kellie Bert Nash Community Mental Health Center - Lawrence

Eunice Ruttinger

Central Kansas Mental Health Center – Salina Glenna Phillips Comcare of Sedgwick County – Wichita Karen McNally Community Mental Health Center of Crawford County – Pittsburg

Diane Salisbury

Cowley County Mental Health & Counseling Center – Winfield

Jennifer Joseph

Four County Mental Health Center – Independence

Mike Alford

High Plains Mental Health Center – Hays Amy Bird Horizons Mental Health Center – Hutchinson Beth Atkins Johnson County Mental Health Center – Shawnee

Tim DeWeese

Kanza Mental Health & Guidance Center – Hiawatha

Rob Hendricks

Labette Center for Mental Health Services – Parsons

Misti Mustain

Mental Health Association of South Central Kansas – Wichita

Carol Manning

Mental Health Center of East Central Kansas – Emporia

Blake Morgan

Pawnee Mental Health Services – Manhattan Charlene Trost Southeast Kansas Mental Health Center – Fort Scott

Karen Owen

Sumner Mental Health Center – Wellington Sheila Schroeder The Elizabeth Layton Center – Ottawa Reg Ayres Valeo Behavioral Healthcare – Topeka Chris Wills Wyandot Center – Kansas City Susan Ruiz

2

Kansas Advocacy Groups Name and Location of Facility Primary Contact Name

Breakthrough House – Topeka Virginia Roland Breakthrough Club of Sedgwick County – Wichita

Barb Andres

Family Life Center, Inc. – Riverton Susan Lopez Prairie View, Inc. – Newton Matt Schmidt South Central Mental Health Counseling Center, Inc. – Augusta

Iris Pauly

Southwest Guidance Center – Liberal Larry Barrows The Center for Counseling and Consultation – Great Bend

Talaya Schwartz

The Guidance Center – Leavenworth Joe Thorne

Kansas Consumer Run Organizations Name and Location of Facility Primary Contact Name

Bridge to Freedom – Osawatomie George Vanderman Bright Horizons – Great Bend Judy Kasson Caring Place – Newton Deborah Dorland Clear Skies – Leavenworth Gary Dozier Come Share Our Growth – Hutchinson Dianne Asher CRO’s Nest – Independence Karen Cook Dodge City Peaceful Tribe – Dodge City Mark Holter Garden City Wolf Pack – Garden City Charlie Rapp Helping Our People Excel (HOPE) – Hiawatha Beth Oswald High Plains Independence – Hays Rick Goscha Live and Let Live – Pleasanton Rick Spano Living (LINC) – Olathe John Reynolds Morning Star – Manhattan Marion Dwyer Nuts & Bolts – Liberal Karen Stipp Project Independence – Wichita Chris Fosher PS Club – Wellington Roger Morton Recovery & Hope Network (RAHN) – Lawrence

Margaret Pittenger

Serenity – Greensburg Denise Hildebrand SIDE – Kansas City Elizabeth Thompson Sunshine Connection – Topeka Christina Ratcliffe The Open Door – Arkansas City Melinda Coffman Wings Upon the Prairie – Colby Galen Smith

Your opinions are important to workbook revisions

Be involved in future content and appearance

Confidential survey

Appendix C

More information

available

from

Case Managers

February 20th

2011 Pathways to Recovery Survey

1545 Lilac Lane ~ Lawrence, KS 66044 (785) 864-3776 ~ (877) 458-6804 (toll-free) ~ (785) 864-51507 (fax)

I, ________________________________________________ (please print), give the University of Kansas School of Social Welfare, Office of Mental Health Research & Training, permission to: ____________ Include my contribution in the 2011 Pathways to Recovery workbook survey

• My input is important to workbook revisions

• All information given during this survey is confidential and kept in a secure location at the School of Social Welfare

Signature __________________________________ Date________________________________

Appendix D

Twente Hall l 1545 Lilac Lane, Room 300 l Lawrence, KS 66044-3184 l (785) 864-4720 l Fax (785) 864-5277 l www.ku.edu Edwards Campus l 12600 Quivira Road, Suite RC210 l Overland Park, KS 66213-2402 l (913) 897-8550 l Fax (913) 897-8657

February 15, 2011 Greetings Case Managers! The Mental Health Team at the School of Social Welfare will be updating their publication, Pathways to Recovery: a Strengths Recovery Self-Help Workbook. Attached is a short survey with questions about the appearance, the content, and possible versions of the book that you may feel are needed. Your input is valuable in determining what is working and what could be improved. All surveys are confidential and for research purposes only. They will be kept in a secure location at the main campus and viewed only by the members of the Pathways to Recovery project. A postage paid envelope will be provided for you to use in returning your survey and those of participating consumers at your organization. Please send them to us by April 30th so that we may use your feedback in our evaluation process of the workbook. Thank you for your time and opinions. Sincerely, Joanna McCloud Pathways to Recovery Project Assistant 785-864-3776

Pathways to Recovery

2011 Survey for Practitioners

Please complete the following survey and return to Joanna McCloud in the postage paid

envelope provided by April 30th.

1. Today’s date: _____________________________________

2. Gender: Female Male

3. Age: ________

4. With which organization are you affiliated? ________________________________________

5. How long have you been using the Pathways to Recovery workbook? ___________________

Appearance of the Book

6. Would you prefer a hardback cover? Yes No

7. Is there too much information on the back cover? Yes No

8. Is the size of the book comfortable to use? Yes No

9. If you answered “no” is the book too large? Yes No

10. Is the color of paper used for the content pleasing? Yes No

11. If you answered “no” is the paper too dark? Yes No

12. Are the line drawings used in illustrating the book appealing? Yes No

13. Would photographs be more effective? Yes No

14. Is the type size easy to read? Yes No

15. Is the font a good choice? Yes No

16. If you answered “no” would you like the font to be more simple or more decorative?

17. Does the chapter tab on each page make finding what you are looking for easier?

Yes No

2

Book Content

18. Is the reading level appropriate for the consumer with whom you work? Yes No

19. If you answered “no” is the reading level too difficult or too easy?

20. Do you feel that the consumer stories are an asset? Yes No

21. Is the material divided into sensible chapters? Yes No

22. Do you change the order of the chapters to best meet the needs of your groups?

Yes No

23. If so, in what order do you usually cover the material? ______________________________

______________________________________________________________________________

24. Do you consider the material current? Yes No

25. Is there a topic or topics you would like to see included in the workbook? ______________

_____________________________________________________________________________

26. Would you like to see more group exercises or less group exercises?

27. Is there sufficient writing space provided for module exercises? Yes No

28. Do you feel comfortable with the chosen supplemental readings? Yes No

29. What supplemental readings would you like to see included? _________________________

______________________________________________________________________________

30. Is a self-check necessary at the end of each chapter? Yes No

31. Would a glossary be helpful? Yes No

Workbook Versions

32. Would a large-print version of the book be helpful to the consumers with whom you work?

Yes No

33. Do you have equipment available to download a digital copy of the book? Yes No

34. Would you like to have access to a downloadable version? Yes No

3

35. Are there blind consumers you know of in need of a Braille version? Yes No

36. Are there blind consumers you know of that would prefer an audio book version?

Yes No

37. Please share any comments and/or suggestions you may have: ________________________

______________________________________________________________________________

______________________________________________________________________________

Thank you for your help in improving the Pathways to Recovery workbook!

Twente Hall l 1545 Lilac Lane, Room 300 l Lawrence, KS 66044-3184 l (785) 864-4720 l Fax (785) 864-5277 l www.ku.edu Edwards Campus l 12600 Quivira Road, Suite RC210 l Overland Park, KS 66213-2402 l (913) 897-8550 l Fax (913) 897-8657

February 15, 2011 Greetings Everyone! The Mental Health Team at the School of Social Welfare will be updating their publication, Pathways to Recovery: a Strengths Recovery Self-Help Workbook. Attached is a short survey with questions about the appearance, the content, and possible versions of the book that you may feel are needed. Your input is valuable in determining what is working and what could be improved. All surveys are confidential and for research purposes only. They will be kept in a secure location at the main campus and viewed only by the members of the Pathways to Recovery project. Please give completed surveys to your Case Manager by April 20th so that we may use your feedback in our evaluation process of the workbook. Thank you for your time and opinions. Sincerely, Joanna McCloud Pathways to Recovery Project Assistant 785-864-3776

Pathways to Recovery

2011 Survey for Consumers

Please complete the following survey and return it to your Case Manager by April 20th. 1. Today’s date: _____________________________________ 2. Gender: Female Male 3. Age: ________ 4. With which organization are you affiliated? ________________________________________ 5. How long have you been using the Pathways to Recovery workbook? ___________________

Appearance of the Book 6. Would you prefer a hardback cover? Yes No 7. Is there too much information on the back cover? Yes No 8. Is the size of the book comfortable to use? Yes No 9. If you answered “no” is the book too large? Yes No 10. Is the color of paper used for the content pleasing? Yes No 11. If you answered “no” is the paper too dark? Yes No 12. Are the line drawings used in illustrating the book appealing? Yes No 13. Would photographs be more effective? Yes No 14. Is the type size easy to read? Yes No 15. Is the font a good choice? Yes No 16. If you answered “no” would you like the font to be more simple or more decorative? 17. Does the chapter tab on each page make finding what you are looking for easier? Yes No

2

Book Content 18. Is the reading level comfortable for you? Yes No 19. If you answered “no” is the reading level too difficult or too easy? 20. Do you feel that the consumer stories are an asset? Yes No 21. Is the material divided into sensible chapters? Yes No 22. Is there a topic or topics you would like to see included in the workbook? ______________ _____________________________________________________________________________ 23. Would you like to see more group exercises or less group exercises? 24. Is there sufficient writing space provided for module exercises? Yes No 25. Would a self-check be helpful at the end of each chapter? Yes No 26. Would 3 months, 6 months and 1 year self-checks be helpful? Yes No 27. Would a glossary be useful? Yes No

Workbook Versions 28. Would a large-print version of the book be useful to you? Yes No 29. Do you have equipment available to download a digital copy of the book? Yes No 30. Would you like to have access to a downloadable version? Yes No 31. Are there blind consumers you know of in need of a Braille version? Yes No 32. Are there blind consumers you know of that would prefer an audio book version? Yes No 33. Please share any comments and/or suggestions you may have: ________________________ ______________________________________________________________________________ ______________________________________________________________________________

Thank you for your help in improving the Pathways to Recovery workbook!