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Background 2
Statement of how research will benefit Rochester Public Schools (RPS) 3
Principal signature (letter of support) 4
Assurance of anonymity of RPS students & staff 5
Copy of “Informed Consent” letter to study population/parents 6-7
Outline of research design 8
Proposed analysis plan 9
Timeline described 10
Copies of measurement instruments 11-14
Copy of IRB application 15-27
No additional advisor signatures No additional funding sources Pending IRB approval
Background: Children’s mental health and wellbeing is identified as a top priority by both local Olmsted County community partners and national level community engaged research reports. Under the broad umbrella of mental wellbeing, outcomes of concern for major stakeholders include attentional difficulties and externalizing disorders (parents and teachers) and the increasing incidence of internalizing problems in the transition from childhood to adolescence (medical and psychological health providers). In the current setting of a global pandemic, parents report increasing concerns about the long term effects of isolation and stress on children’s’ long term wellbeing.
Social-emotional learning (SEL) programs have emerged over the last 3 decades as a school based curricular intervention to promote positive social behaviors and relationships and reduce emotional distress in youth. SEL programs are generally as Tier 1 or Tier 2 behavioral supports, meaning they provide skills either as primary prevention (Tier 1) or as targeted support for students at risk of developing more serious behavioral problems (Tier 2). In either case, they are generally intended to be delivered before the problem behaviors start.
HappiGenius is a SEL curriculum that uses behavioral practices including breathing, focusing, and feeling exercises to (1) build attention, (2) social skills, (3) enhance self-awareness, and (4) improve self kindness and (5) access to uplifting emotions (https://www.happigenius.com/). HappiGenius has been selected as an optimal curriculum because of its evidence based design with a focus on behavioral practices. HappiGenius uses behavioral modification to promote skill uptake and utilization, which can reinforce cognitive changes taking place in social-emotional learning. It includes mindfulness and self-awareness components, which have been shown to strengthen executive functioning skills needed for long-term success and be foundational to other social-emotional learning skills. In addition, HappiGenius uniquely fosters self-kindness in addition to compassion towards others, which is gaining increasing evidence for importance in mental- emotional wellbeing. Finally, HappiGenius is an affordable, scalable, and adaptable intervention that can fit into a variety of settings. In addition to the English edition, translations are in the works to reach Spanish speaking children and Spanish immersion classrooms.
Benefits of participation: Students: The direct benefit to students is the receipt of the HappiGenius curriculum. HappiGenius is a social-emotional learning program designed in alignment with the principles of Positive Behavioral Interventions and Supports as primary prevention of problem behaviors and social-emotional difficulties. There is a potential benefit to future students in the upcoming school year to benefit from the revisions made to the curriculum following this study. Education: Beyond the direct benefit to the participating students, students' responses will provide generalizable knowledge in the field of wellbeing education about the effectiveness of the HappiGenius and InSciEd Out curricula in improving student knowledge, learning attitudes, and social and emotional wellbeing. The study design will allow us to draw meaningful conclusions about the optimal ordering of the HappiGenius and InSciEd Out curricula for future delivery. This will be helpful as we continue to improve curricula for primary prevention and health promotion in student populations. Teachers: Teachers will have the option to participate in Resilient Option, a four session evidence-based Stress Management and Resilience Training program. Clinical trials demonstrate this program is successful in improving the general wellbeing of voluntary adult participants, including those in stressful occupations with high levels of burnout. We anticipate the combination of offering Resilient Option and having the concepts modeled in the HappiGenius classroom teachings will have a net positive effect for teachers, especially during these stressful times.
January 13, 2021
Mayo Clinic
200 First Street SW
Rochester, MN 55905
Mayo IRB Committee,
My name is Kris Davidson, and I am the principal of Gage Elementary School. I am writing to express
support for the project Pilot Study of HappiGenius Social-Emotional Learning Curriculum in Rochester
Public Schools. This project is an extension of an ongoing collaboration between the Integrated Science
Education Outreach (InSciEd Out) program and Gage Elementary School along with HappiGenius.
Here at Gage Elementary School, our partnerships seek to improve the 6 core skillsets of our graduate
profile. The HappiGenius curriculum targets the skillsets of Ethical Contributor, Effective Collaborator,
and Resilient learner while the InSciEd Out curriculum targets the skillsets of Critical Thinker, Skilled
Communicator, and Success-Ready Individual. We hope to use HappiGenius alongside InSciEd Out in our
future cohorts of students. To optimize the delivery and timing of these curricula, we wish to apply in-
depth research questionnaires and study groups to assess the curricular efficacy. Therefore, approval of
the metrics included in this IRB submission is important in evaluation and revision of our enacted
lessons. I would also like to voice strong support for the opt-out consent process proposed in the
protocol.
Investment in this project at Gage Elementary School will have long-lasting impacts on our community.
Gage Elementary School is excited to help advance research in the field of education and the social-
emotional wellbeing of students.
Respectfully,
Kris Davidson Principal Gage Elementary Phone: 507-328-3400 Email: [email protected]
Assurance of anonymity (data safety plan):
1. Data Integrity No responses are forced in this study. To assure data provided are as complete as possible and accurate, study ID’s will be assigned to students and used through the duration of the study. Responses will be input into a secure electronic file by the study staff (Kit Knier) and reviewed twice for accuracy.
2. . Subject Privacy Study ID, rather than name, will be used throughout the study. Name and study ID will be stored in a secure key on Mayo Clinic servers. This key will be kept separately from the data to further protect subject privacy. Furthermore, in reporting, all results will be reported in aggregate to prevent the identification of an individual from the study group.
3. . Data Confidentiality Access to the data and access to the key will be in a private folder stored securely behind Mayo Clinic (IRB of note) firewall. Access will be reviewed on a periodic basis to ensure only those on an active IRB with permission to access the data and/ or the key can do so.
In addition, we pledge to work with our community partners at Gage Elementary School in the
preparation of any publications or presentations to ensure fair representation of the school
systems in any external communications.
IRB 10557.001
IRB# 20-012907
{Date}
Protocol Title: Pilot Study of HappiGenius Social-Emotional Learning Curriculum in
Rochester Public Schools
IRB #: 20-012907
Principal Investigator: Michael Bostwick, MD Dear Parent/ Guardian, Gage Community Elementary School and Mayo Clinic are working together to improve
the social and emotional wellbeing of students in our schools and in our community. As a
part of a research study, we are interested in learning how the 3rd
grade curriculum
empowers healthier student thoughts and attitudes. To do this, we would like to ask your
child and their teacher to complete a short questionnaire.
This questionnaire will be completed three times: once before the start of classroom
curriculum, once after 6 weeks, and once after the curriculum is complete. These
questionnaires will ask about your child’s attention, experiences of positive emotions,
self-kindness, interactions with peers, and behaviors in the classroom. The answers from
the questionnaire will be used to help us understand how we can teach them better so that
they know how to stay healthy socially and emotionally.
A copy of the questions is available by request. The answers your child provides to the
questions are confidential and will not be seen by any teachers or school staff. The
answers will not have any effect on your child’s grades.
If you do not want your child to answer these questions, please send an email
([email protected]) or leave a voicemail message (847-946-1902) stating this
request with your name and your child’s first and last name. The deadline for letting us
know if you do not want your child to take part in answering these questions is {date, no
less than 2 weeks before first assessment, will be added here}.
If you have any questions, please contact us directly by email or voicemail message.
Thank you very much.
Sincerely,
Kit Knier Michael Bostwick, MD
Mayo Graduate School Professor, Dpt of Psychiatry and Psychology
Ph: (847-946-1902) Mayo Clinic College of Medicine
Approval Date:
Not to be used after:
Page 1 of 1 IRB Template Ver: 9/7/2016
IRB#: IRB FORM 10015.006
Name and Clinic Number
Protocol #:
Subject ID:
Version #:
Version Date:
Assent Form to Take Part in a Research Study
TITLE: PILOT STUDY OF HAPPIGENIUS SOCIAL-EMOTIONAL LEARNING
CURRICULUM IN ROCHESTER PUBLIC SCHOOLS
IRB #: 20-012907
PRINCIPAL INVESTIGATOR: Dr. Michael Bostwick, MD and Colleagues
You are being asked to be in a research study. This study will help us learn more about your
school’s classes in social and emotional learning.
You will be asked questions about your thoughts, feelings, and behaviors.
Your name will not be recorded with your answers. No one will know your answers. This is not
a test for school, and no one will give you a grade for your answers.
If you agree to answer the questions, check the “Yes” box below. Check the “No” box if you do
not agree to answer the questions.
If you do not want to be in this research study, you do not have to say yes or sign your name on
this form. No one will be mad at you if you say no.
( ) Yes ( ) No Date____________
If you answered “Yes,” please fill out the rest of this packet.
If you answered “No” above, please do not continue to fill out the rest of this packet. Instead,
return your packet to a study team member.
Research Design
This is a three arm cluster randomized trial taking place in 3rd grade students at Gage Community Elementary School, a member of Rochester Public Schools (MN). Arm 1 receives the 12 module HappiGenius curriculum over the course of 6 weeks. The parallel Arm 2 will receive a time-matched InSciEd Out science curriculum that does not include mental health or mindfulness components. Arm 3 consists of classrooms for which teachers have opted out of delivering the curriculum this year but agreed to participate in the survey measurements. Arm 3 will receive education as usual and complete the measures in the same timeline as the other arms. The arms will be compared to determine whether HappiGenius effectively delivers the core social-emotional learning skills of self-awareness, self-management, and social skills in addition to the unique elements of self-kindness and positive affect. Clusters are illustrated in Figure 1 for clarity.
The intervention will be delivered by trained, school-approved delivery agents in person, or in the case of a transition to full-time distance learning, in the virtual classroom environment. Each module is 45 minutes long, for a total of two 45 minute sessions each week over 6 weeks (1.5 hours per week or 9 hours over 6 weeks). Delivery agents will complete a brief checklist after each session to confirm delivery of core curriculum components.
To assess the secondary endpoint of whether academic performance is improved by receiving HappiGenius before InSciEd Out science programming, the clusters will crossover to receive the other intervention after a 1 week wash out period.
If the intervention shows a positive effect, HappiGenius team members would then offer a wider
rollout in the fall for all 1st– 3rd grade classrooms and professional development training in the module to interested Gage teachers.
HappiGenius transition InSciEd Out
InSciEd Out transition HappiGenius
Classroom 1
Classroom 2
Analysis plan
Quantitative analysis will occur in a blinded manner by removing name, classroom, or any other grouping detail that could be used to identify the study arm from the data before analysis. Descriptive statistical reports will be generated for each assessment measure. Data with sufficient sample size (n>20), normal distribution and similar standard deviation (a ratio of <1.5) will be evaluated using parametric t-test; otherwise non-parametric testing will be utilized. The assessments will each first be compared between groups for each Visit 1, 12, and 24 using unpaired testing to evaluate the primary hypothesis. The assessments will then be compared using paired testing to determine whether there were changes from baseline to evaluate secondary outcomes. Moderator analyses will be completed to account for student attendance, baseline characteristics, parental engagement, delivery agent experience and program core component delivery fidelity. Endpoints Primary: (Endpoint, measure)
Attention, Strengths Difficulties Questionnaire (SDQ, teacher report)
Positive affect, PANAS-C-PA (self-report)
Self-awareness, the mindful attention awareness scale for children (MAAS-C, self-report)
Sociality, SDQ (teacher report)
Self-kindness, self-compassion scale for youth (SCS-Y, self-report)
Learning outcomes, MCA math and reading, year-end math scores Secondary: (Endpoint, measure)
Internalizing tendencies, SDQ (teacher report)
Externalizing tendencies, SDQ (teacher report)
Study timeline
Experimental arm Active control arm Convenience control
Week 1
March 1
Survey measures
HappiGenius 1, 2
Survey measures
InSciEd Out 1, 2
Survey measures
Week 2
March 8
HappiGenius 3, 4 InSciEd Out 3, 4
Week 3
March 15
HappiGenius 5, 6 InSciEd Out 5, 6
Week 4
March 22
HappiGenius 7, 8 InSciEd Out 7, 8
Week 5
April 5
HappiGenius 9, 10 InSciEd Out 9&11, 10
Week 6
April 12
HappiGenius 11, 12
Survey measures
Qualitative focus groups
InSciEd Out, 12, 13
Survey measures
Survey measures
Week 7
April 19
InSciEd Out 1, 2 HappiGenius 1, 2
Week 8
April 26
InSciEd Out 3, 4 HappiGenius 3, 4
Week 9
May 3
InSciEd Out 5, 6 HappiGenius 5, 6
Week 10
May 10
InSciEd Out 7, 8 HappiGenius 7, 8
Week 11
May 17
InSciEd Out 9&11, 10 HappiGenius 9, 10
Week 12
May 24
InSciEd Out 12, 13
Survey measures
HappiGenius 11, 12
Survey measures
Survey measures
Student contact materials Items will be delivered pre-, mid-way, and post-curriculum. Items will be delivered via either Mayo Clinic
REDCap or Qualtrics accounts if online or on paper in person. The questions will be preceded by the
assent document each time it is delivered.
Positive affect, PANAS-C-PA This scale consists of a number of words that describe different feelings and emotions.
Read each item and then circle your answer next to that word.
Indicate how much you have felt this way during the past few weeks.
Not much or not at all
A little Some Quite a bit A lot
Interested 1 2 3 4 5
Alert 1 2 3 4 5
Excited 1 2 3 4 5
Happy 1 2 3 4 5
Strong 1 2 3 4 5
Energetic 1 2 3 4 5
Calm 1 2 3 4 5
Cheerful 1 2 3 4 5
Proud 1 2 3 4 5
Joyful 1 2 3 4 5
Fearless 1 2 3 4 5
Delighted 1 2 3 4 5
Daring 1 2 3 4 5
Lively 1 2 3 4 5
Mindful awareness, MAAS-C
Self-kindness, SCS-C
1
2
