Pediatric Insomnia Journal

7/30/2019 Pediatric Insomnia Journal

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EffectsofaStandardizedPamphletonInsomniainChildrenWithAutismSpectrumDisorders

KarenW.Adkins,CindyMolloy,ShellyK.Weiss,AnnReynolds,SuzanneE.Goldman,CourtneyBurnette,TraciClemons,DianeFawkesandBethA.MalowPediatrics2012;130;S139

DOI:10.1542/peds.2012-0900K

Theonlineversionofthisarticle,alongwithupdatedinformationandservices,islocatedontheWorldWideWebat:

http://pediatrics.aappublications.org/content/130/Supplement_2/S139.full.html

PEDIATRICSistheofficialjournaloftheAmericanAcademyofPediatrics.Amonthlypublication,ithasbeenpublishedcontinuouslysince1948.PEDIATRICSisowned,published,andtrademarkedbytheAmericanAcademyofPediatrics,141NorthwestPointBoulevard,ElkGroveVillage,Illinois,60007.Copyright2012bytheAmericanAcademyofPediatrics.Allrightsreserved.PrintISSN:0031-4005.OnlineISSN:1098-4275.

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SUPPLEMENTARTICLE

EffectsofaStandardizedPamphletonInsomniainChildrenWithAutismSpectrumDisordersAUTHORS:KarenW.Adkins,MA,RN,aCindyMolloy,MD,MS,bShellyK.Weiss,MD,FRCPC,cAnnReynolds,MD,dSuzanneE.Goldman,PhD,aCourtneyBurnette,PhD,eTraciClemons,PhD,fDianeFawkes,BS,aandBethA.Malow,MD,MSaaSleepDisordersDivision,DepartmentofNeurology,VanderbiltUniversityMedicalCenter,Nashville,Tennessee; bDepartmentofPediatrics,AutismSpeaksCommunityPartner,Cincinnati,Ohio;cDepartmentofPaediatricsUniversityofTorontoHospitalforSickChildren,Toronto,Ontario,Canada; dDepartmentofPediatrics,ChildrensHospitalColorado,Aurora,Colorado; eDepartmentofPediatrics,VanderbiltUniversityMedicalCenter,Nashville,Tennessee;and fEMMESCorporation,Rockville,MarylandKEYWORDSsleep,education,actigraphy,sleeplatencyABBREVIATIONSASDautismspectrumdisorderATNAutismTreatmentNetworkCSHQChildrensSleepHabitsQuestionnaireSESsocioeconomicstatusThismanuscripthasbeenreadandapprovedbyallauthors.Thispaperisuniqueandnotunderconsiderationbyanyotherpublicationandhasnotbeenpublishedelsewhere.www.pediatrics.org/cgi/doi/10.1542/peds.2012-0900Kdoi:10.1542/peds.2012-0900KAcceptedforpublicationAug8,2012AddresscorrespondencetoBethA.Malow,MD,MS,VanderbiltUniversityMedicalCenter,Nashville,Tennessee37232.E-mail:[email protected](ISSNNumbers:Print,0031-4005;Online,1098-4275).Copyright2012bytheAmericanAcademyofPediatricsFINANCIALDISCLOSURE:Theauthorshaveindicatedtheyhavenofinancialrelationshipsrelevanttothisarticletodisclose.

abstractOBJECTIVE:Sleepdifficultiesarecommonreasonswhyparentsseekmedical intervention in children with autism spectrum disorders(ASDs). We determined whether a pamphlet alone could be used byparentstohelptheirchilds insomnia.METHODS: Thirty-six children with ASD, ages 2 to 10 years, wereenrolled. All had prolonged sleep latency confirmed by actigraphyshowing a mean sleep latency of 30 minutes or more. Parentswererandomly assigned to receive the sleep education pamphlet or nointervention. Children wore an actigraphy device to record baselinesleep

parameters,

with

the

primary

outcome

variable

being

change

in sleep latency. Actigraphy data were collected a second time 2weeks after the parent received the randomization assignment andanalyzed byusing Students t test.Parentswere also asked aseriesof questions to gather information about the pamphlet and itsusefulness.RESULTS:Althoughparticipantsrandomizedtothe2armsdidnotdif-ferstatisticallyinage,gender,socioeconomicstatus,totalChildrensSleep Habits Questionnaire score, or actigraphy parameters, somedifferences may be large enough to affect results. Mean change insleep-onset latency did not differ between the randomized groups(pamphlet

versus

no

pamphlet).

Parents

commented

that

the

pamphlet contained good information, but indicated that it wouldhave been more useful to be given specific examples of how totaketheinformationandputit intopractice.CONCLUSIONS:AsleepeducationpamphletdidnotappeartoimprovesleeplatencyinchildrenwithASDs. Pediatrics2012;130:S139S144

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Childrenwithautismspectrumdisorder(ASD)haveaneurologicdevelopmentaldisability withimpairments insocial in-teraction and communication that mayalso be accompanied by restrictive, re-petitive, and stereotypical behaviors.Currentstatisticsestimatethatonaver-age,1of110childrenintheUnitedStateshave an ASD diagnosis.1 Approximately40%to80%ofparentsofchildrenwithASD report sleep problems comparedwith 9% to 50% of parents of typicallydevelopingchildren.25Themostcommonreported parental concern is insomnia,definedashavingdifficultyfallingasleep.Behavioral and pharmacologic inter-ventionshavebeenadvocatedtoaddressthese

parental

sleep

concerns

6,7Inanearlierstudy,wereportedsuccessinanopen-labelstudyof 20childrenwithASD with parent-based sleep educationworkshops using a small-group formatwith 6 hours of education. Sleep-onsetlatency, measured by actigraphy, im-provedwithtreatmentfrom62.2minutesto 45.6 minutes.8 The objective of thecurrentstudywastofurtherevaluatetheefficacyofsleepeducationforparentsofchildren

with

ASD

within

a

controlled

randomized clinical trial. The specificobjectivesweretodetermineifdistribu-tion of a sleep pamphlet, developedwithin a large autism patient network,could help parents assist theirchild tohavebettersleep.Webelievethattestingtheefficacyofapamphlet,beforemoreinteractiveeducation,isimportantgiventhe costs associated with providing in-teractive education. Educational pam-phlets have been developed for otheraspectsofmedicalcareforchildrenwithASD, including phlebotomy.9 Sleep pam-phlets have been developed for infantsandtoddlerswithtypicaldevelopment.10Ourreviewoftheliteraturedidnotiden-tifyanASD-specificpamphletforsleep.METHODSThestudywasconductedinparentsandtheirchildrenwithASDtodeterminethe

efficacyofparentaluseofasleepedu-cationpamphlettohelptheirchildim-provesleeplatency(timetofallasleep).The Autism Speaks Autism TreatmentNetwork(ATN)isanetworkof17sitesacrossNorthAmericadedicatedtode-velopingstandardsofcareforchildrenwith ASD that includes standardizedcollection of data, such as autism di-agnosis,diagnostichistory,andcomor-bidconditionsassociatedwithASD.Thechildrenwererecruitedforthisstudyat2 different sites, Vanderbilt UniversityMedicalCenterandCincinnatiHospitalChildrensMedicalCenter,byscreeningATNparticipants whoseparentsrepor-ted prolonged sleep latency on theChildren

sSleep

Habits

Questionnaire

(CSHQ)(oneofthestandardizedques-tionnaires in the ATN protocol). Theseparentswerecalledtospecificallyaskiftheirchildtookat least30minutestofallasleepon3ormorenightsaweek,and actigraphy was used toverify pa-rentalreport.ParticipantsandStudyCriteriaInstitutionalreviewboardapprovalwasreceived at both sites. All parents ofchildren with ASD provided informedconsent. Study criteria included thefollowing: (1) ages 2 to 10 years; (2)diagnosisofASD,basedonainterviewthatincorporatedDiagnosticandSta-tistical Manual of Mental Disorders,FourthEdition,TextRevisioncriteria11with confirmation by the Autism Di-agnostic Observation Schedule12; (3)sleep-onsetlatency(timetofallasleep)ofatleast30minuteson3of7nightsa week based on parent report andconfirmed by 14 scorable days ofactigraphy showing a mean sleep la-tency of 30 minutes or more; (4)medication-freeoronastabledoseofmedications(nochangewithin30daysofenrollmentinthetrial)withparentsagreeing to avoid changes in cur-rent medications or the start of newmedications during the time of study

participation;(5)abilityforthechildtotolerateactigraphyandwillingnessofparent(s) to complete the corre-spondingsleepdiary;(6)Englishasthefamilys primary language as thepamphletisinEnglish.All children were screened by a de-velopmental pediatrician to excludemedicalandbehavioralcomorbiditiesthataffectsleep,includingsleepapnea,epilepsy,gastrointestinalrefluxdisease,depression, anxiety, and attention-deficit/hyperactivity disorder. Thosechildren found to have untreated co-morbidconditionswereexcludedfromthestudy.Intervention: SleepEducationPamphletThe main study intervention was theprovision of a sleep education pam-phlet to parents. The pamphlet is 4pages in length and written at aneighth-gradereadinglevel.Itisavail-ableatwww.autismspeaks.org/atn.ItwasdevelopedbytheATNSleepCom-mitteeforuseinATNclinicalsettings.Itincludesinformationabout6areasrelevant to promoting sleep amongchildren with ASD: (1) providinga comfortable sleep setting; (2)establishing regular bedtime habits;(3) keeping a regular schedule; (4)teaching your child to fall asleepalone; (5) avoiding naps (in childrenwho have outgrown the need fora daytime nap); and (6) encouragingdaytimeactivitiesthatpromoteabet-tersleep/wakeschedule.Attheendoftheintervention,parentswhoreceivedthepamphletwereaskedfor feedback about what was mostuseful about the pamphlet and whatmight have been more useful. Theprimaryintentofaskingthisquestionwastoensurethatparentshadreadthe pamphlet; the secondary intentwastolearnwhatthepamphletmightbe contributing to help their childsleep.

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SUPPLEMENTARTICLE

ActigraphyandSleepDiaryDataCollectionActigraphyisalow-cost,well-validatedmethodology for measuring sleepparameters,particularlysleep-onsetlatency, including change with inter-vention,inchildrenwithASD.8,13,14Theparental report of sleep latency of atleast 30 minutes on at least 3 of 7nightswasconfirmedusingactigraphydevices for sleep data collection. Allchildren wore the AW Spectrum Acti-watch device (Phillips Respironics,Bend, OR). The device was configuredby using a 1-minute epoch with me-dium threshold, andavalidated Mini-Mitter software (version 5.9, PhillipsRespironics) algorithm was used toestimate sleep parameters, based onthresholdsforwakeandsleep,asde-scribedinpreviouswork.1517Parentswereintroducedtotheactigraphydevice procedures via a structuredtrainingsessionthatincludedhands-ondemonstration with visual supportsthat include both graphic and de-scriptivedetails.Parentswererequiredto demonstrate understanding of themethods by successfully completingawrittenexaminationregardingdetailsof the actigraphy device and the ac-companyingdailysleepdiary.Parentswere asked to record sleep/wakedetailsonthesleepdiaryeachdayofthetrialandhavetheirchildwearthedeviceforatleast21days.Duringthetrainingsession,theparentand child were introduced to theactigraphydeviceforplacementonthenondominantwrist.Childrenwhohaddifficulty tolerating the device on thewristwereallowedtouseanalternatevalidated method, which consisted ofplacing the device on a nondominantshoulderlocation.5,18Oncethedeviceplacementprocedurewasestablished,theparentsweregiven2devicesandthecorrespondingdailydiaryformstocollectatleast21daysofcontinuoussleepdata.Thefirstdevice

was programmed for 7 days of con-tinuous data collection with parentalinstructiontomailthedevicetothesiteonthemorningofday8.Theparentwasinstructedtoplacetheseconddeviceonthechildinthesamemanner(wristorshoulder)onthemorningofday8forcollection of an additional 14 days ofsleepdata.Oncethedeviceswerere-ceived by the study investigators, theparentswerecontactedbyphoneandfeedbackwasprovidedtoparentsre-gardingaccuracyofsleepdatacollec-tion and a report of the number ofscorabledaysofthedeviceandsleepdiary data. All actigraphy data wereuploadedtoadatabasehousedattheVanderbilt

site

for

centralized

scoring,

byasingleindividual,asavaliditymea-sure.Asanadditionalvaliditymeasure,thecentralizedscoringstaffmemberhadno other contact with participants ortheirfamilies.AdditionalStudyMeasuresCSHQThetotalsleepscorewasderivedfromthe CSHQ, a parental questionnairedescribingsleepbehaviorsinchildren.TheCSHQhasbeenvalidatedinchildrenages2to10years19andhasbeenusedwidely in the ASD literature.2022 Addi-tionaldatadocumentingsocioeconomicstatus(SES)(4-factorHollingsheadIndexof Social Status) were collected toensure that our groups randomizedtothepamphletornopamphletarmdidnotdiffer.23WealsoassessedtheIQforeachchildusingtheStanford-Binet5or theMullenScalesofEarlyLearning.RandomizationSimplerandomizationstratifiedbyagegroup(25yearsand610years)andparticipating sitewereusedtoassigntreatmentgroups.Stratificationbyagewasdonetoensurethatno1agegroupwasoverrepresentedineitherarmofthe study. Participantswere assigned

equallytothepamphletorno-pamphletgroups.Thoseparentswhowererandomizedtothepamphletarmreceivedacopyofthepamphletandwereinstructedtoreaditwithoutfurtherinstructionsfromstudystaff.Thestaffdidnotanswerquestionsregarding the pamphlet. Parents ran-domizedtotheno-pamphletarmwerenotifiedthattheywouldbereceivingthepamphletattheendofthestudy,afterthey had completed all study proce-dures.Twoweeksafterrandomization,all parents were asked to have theirchild wear the actigraphy device andrecordonthedailysleepdiaryforanadditional2weeksofpostintervention(pamphlet versus no-pamphlet) datacollection.Allchildrenworethedevicefor these final 2 weeks in the samemanner (nondominant wrist versusnondominant shoulder pocket) thatwas tolerated in the initial weeks ofactigraphy data collection. Once post-intervention actigraphy data were re-ceived by the site, those parentsrandomizedtothepamphletarmwereaskedaseriesofquestionstocollectparent

feedback

on

pamphlet

use.

Those parents randomized to the no-pamphlet arm received a copy of thepamphlet for review after receipt oftheirpostinterventionactigraphy.DataAnalysisDatafromtheactigraphsweredown-loadedtoacentralizedcomputerwhereall sleep intervals were manuallyplaced on the actogram for visualrepresentationoftheactigraphydata.Thesleepmeasuresofsleep-onsetla-tency(primaryoutcomevariable),totalsleeptime,sleepefficiency,andwakeaftersleeponsetwerecalculatedbasedontherecommendationsofBuysseandcolleagues.24Totalsleeptimewasde-finedasactualtimeslept,whichisthesumofallsleepepochs,measuredinminutes, within the interval betweenthe time set on the actogram fornighttime sleep and morning wake



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time. Sleep-onset latency was definedas the numberof minutes it took thechild to fall asleep when the parentturnedthelightsoutandexpectedthechild to fall asleep. This time wasdocumented by the parent using thedeviceeventmarkerandthesleepdi-ary. Sleep efficiency was defined aspercentageoftotalsleeptime/timeinbed. Wake after sleep onset was de-fined as the total time the child wasawakeduringthenightafterthesleep-onsetlatencywasexcluded.Wakeaftersleeponsetwasmeasuredasthesumof all wake epochs during the sleepperiod. Fragmentation index, whichcaptures all movement regardless oftheintensityofthemovement,wasalsoincluded,aspreviousworkhasshownan association with poor sleep conti-nuity,17andinchildrenwithASD.Frag-mentation index is a measure ofnocturnalmovementthatiscalculatedbyusingthefollowingformula:(num-berofmobileepochslasting4epochs1 number of immobile epochs , 1minute duration/number of immobileepochs . 1 minute duration) 3 100.The

participants

in

our

study

got

out

of

bedforthedayonawakening,withthistimedesignatedbytheparentpushingtheeventmarkeranddocumentingthissameinformationontothesleepdiaryform. Wake after sleep onset did notinclude wake time in bed before thefinalarisingandwedidnotencounterterminalwakefulness.Theprimaryanalysiswastodetermineifchangeinactigraphicallymeasuredsleep-onset

latency

from

baseline

to

treatmentdifferedamongparticipantsrandomizedtothepamphletversusnopamphletstudygroup.Wealsoanalyzedthe change in sleep-onset latency forindividual participants and comparedthischangebetweenthe2randomiza-tion groups (pamphlet versus no-pamphletstudygroup).The study was designed to enroll 36participants (18 subjects perarm) to

provide at least 80% power to detectadifferenceinmeanchangeintimetofall asleep of at least 30 minutes, as-suming a common SD of 30 minutesusinga3-groupttestwitha.052-sidedsignificance level and a 10% loss tofollow-up rate. This 30-minute differ-encewaschosentorepresentaclini-callymeaningfulresult.Secondaryanalyseswereconductedtodetermine whether other actigraphicvariables, including total sleep time,sleepefficiency,waketimeaftersleeponset, and fragmentation, differedamong participants based on ran-domization.Finally,wewantedtocon-firmthatactigraphyplacement(wristversusshoulder)didnotaffectchangein sleep-onset latency with an inter-vention by examining differences be-tween sleep-onset latency before andafter intervention. Our previous pub-lished work had shown comparableresults for the 2 devices worn simul-taneously.Fortheprimaryanalysis,meanchangein sleep-onset latency (baseline valuetreatmentvalueforeachparticipant)betweenthe2armsandthesecondaryanalysesofmeanchangeintotalsleeptime,sleepefficiency,waketimeaftersleeponset,andfragmentation(base-line value treatment value for eachparticipant)betweenthe2armswerecomparedbyusingStudentsttest.In-dependent analyses of the baselinecharacteristics and actigraphy place-mentwerealsoconductedbyusingtheStudentsttest.RESULTSThe study population consisted of 36children,ofwhom24(67%)weremale.Theageofthechildrenwas6.462.6years (mean 6 SD). Eighteen partic-ipants were randomized to the pam-phlet arm and 18 subjects wererandomizedtotheno-pamphletarm.Ofthe16childrenonmedications,mela-toninwasthemostcommonlyused(in

8 children). Other medications usedwere risperidone, aripiprazole, sertra-line,lamotrigine,andfluoxetine.Demo-graphics and other characteristics ofourstudypopulationarelistedinTable1.Allparticipantswhowereconsentedto the study were able to tolerate theactigraphydevice.There were no significant differencesbetween the participants randomizedtothe2armsintermsofage,gender,SES, total CSHQ score, or actigraphyparameters (P . .05 for each com-parison), although, as Table 1 indi-cates,someofthesedifferencescouldhave affected response to the in-terventioninthe2groups.Inaddition,no significant differences were foundfor the change in sleep-onset latencyacrossgenderandagestrata,andnosignificantcorrelationswerefoundonsleep-onset latency in relation to SESscore or total CSHQ score (data notshown).Inourprimaryanalysis,subjectsran-domized to pamphlet or no-pamphletbased on treatment arm were com-pared. Mean change in sleep-onsetlatency did not differ between therandomized groups (pamphlet versusno-pamphlet). In addition, the meanchangeintotalsleeptime,waketimeTABLE1 DemographicsandStudy

PopulationCharacteristicsIntervention Control

Age,y25 9 6610 9 12

Male 10 14RaceWhite 15 14

AfricanAmerican 3 3SESmean(SD) 34.0(16.7) 41.1(11.9)Diagnosis

Autism 16 13Aspergers 2 4PDDNOS 0 1

IQmean(SD) 75.1(25.5) 85.6(27.1)Medicationsa

Psychotropic 5 9Melatonin 3 3Stimulants 2 2

aSomechildrenwereonmorethan1medication.S142 ADKINSetal



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SUPPLEMENTARTICLE

after sleep onset, and fragmentationdidnotdifferbetweentherandomizedgroups.Theonlysleepparameterthatshowed significance with randomizedtreatment was the mean change insleepefficiency(Table2).WristVersusShoulderPlacementThewristplacementwastoleratedby27 (75%) children, whereas 9 (25%)children required the shoulder place-ment.Therewerenosignificantdiffer-encesbetweenthewristandshoulderplacements for mean sleep-onset la-tencyoranyotheractigraphically mea-sured sleep parameters at baselineor treatment. Analysis of the meanchangeinsleepparametersfrombase-line to treatment, when comparedacross actigraphy placement (wristversusshoulder)didnotshowsignifi-cantdifferences.PostinterventionFeedbackAboutthePamphletParentscommentedthatthepamphletwas useful in that it contained goodinformation, and cited specifics in-cluding basic rules for sleep, andimportance of consistent bedtime.They indicated that what might havebeenmoreusefulwouldhavebeentohavemore-specificideasofhowtotaketheinformationandputitintopractice.DISCUSSIONInthisrandomizedcontrolledstudyin36childrenwithASD,theparentswere

randomizedtoreceiveasleeppamphletornosleeppamphlet.Wemeasuredtheactigraphy parameters of sleep-onsetlatency (primary outcome variable),totalsleeptime,sleepefficiency,wakeafter sleep onset, and sleep fragmen-tation before randomization proce-duresandagainaftertherandomizationprocedures. We determined that thepamphlet alone, without further in-structionforitsuse,appearsinsufficientto significantly improve the sleep pat-terns of children with ASD. Althoughsleep efficiency showed a statisticallysignificant improvement, a 2-point im-provement in sleep efficiency from75%to77%isunlikelytobeclinicallymeaningful.

Ourstudyhasseveralstrengths.First,we used a well-defined sample withprecisediagnosticprocedurestocon-firmthediagnosisofASD.Second,werandomized parents to receive thepamphletornopamphlet,andincludeda series of questions to ensure thatparentswhoreceivedthepamphlethadrevieweditscontent.Third,sleep-onsetlatencywasconfirmedbytheobjectivemeasure

of

actigraphy.

Finally,

our

studywaspoweredtoensurethatwehad a sufficient sample to determineadifferenceinmeanchangeinsleep-onset latency of at least 30 minutesbetweenthe2groups.Werecognizethatthissamplesizeassumeshomogeneitywithin the groups and that the ran-domizationdidnotachievefullysimilarsamplesintheexperimentalandcon-trolgroups.Thus,itispossiblethatour

study findings were confounded bysampledifferences.Oursmallsamplesizedidnotpermitcontrollingforthese.We set a high bar for the pamphlet,especiallygiventhatinapreviousstudyofgroupparenteducation,weachievedanimprovementofonly17minutesinsleep-onset latency.10 We felt it wasimportant, however, to determinewhether the pamphlet was able toachieve a clinically meaningful differ-ence, not only adifference consistentwith results from a small pilot study,before moving forward with a largerparenteducationtrial.Study weaknesses included a smallsample size that did not allow us toadjust for covariates including age,gender,andSES,althoughthesevaria-bleswerenotsignificantlydifferentinthe 2 groups. We also recognize thatchildren with ASD often have chronicand intractable sleep-related difficul-ties.Theyfrequentlyresistchangesintheirroutineandrequireincrementalchange for effectiveness. Therefore,alongerfollow-upperiodthan2weeksmighthaveresultedinmoreimprove-mentwiththepamphlet; however,wewereconcernedthatparentswouldgetdiscouragedandimplementadditionaltreatments, including medications ormore intensive educational programsthat would confound our results. Wealso recognize that we could haveprovidedthecontrolgroupwithadif-ferentintervention,suchasapamphleton feeding issues to better blind thestudyparticipants.

TABLE2 GroupDifferencesinPamphletVersusNoPamphletforSleepParametersPamphlet(n=19) NoPamphlet(n=17) P

valueaWealsoshowedthatashoulderplace-ment foractigraphy can be used suc-cessfullyinaninterventionalstudy.We

BaselineMean(SD) TreatmentMean(SD) BaselineMean(SD) TreatmentMean(SD) previously published on reliability of

shoulder and wrist placement in chil-Sleeplatency,min 56.7(27.1) 49.5(26.7) 52.1(25.1) 61.3(47.0) .16Sleepefficiency,% 75.5(6.1) 77.8(7.0) 76.8(6.0) 75.1(6.7) .04Wakeaftersleeponset, 61.9(27.4) 60.4(32.1) 53.2(20.2) 59.9(24.2) .22

minTotalsleeptime,min 465.7(66.3) 483.0(67.8) 461.4(42.4) 470.8(35.3) .55Fragmentation, min 36.8 (9.0) 36.3 (10.9) 32.2 (7.2) 33.3 (7.5) .52aPvaluesforthesleepparameterswerebasedonpairedttestcomparingthemeanchangeinthesleepparameter(baselinetreatment)forthe2groups.

drenwithASD16andothershaveshownsimilar results in typically developingchildren.7Thisalternativeplacementforactigraphy extends the population ofchildren with ASD who can partici-pate in studiesusingactigraphy. Such



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childrenmayincludethosewithtactilesensitivities or other aversions towearingwristdevices.Inthisstudy,theuse of the alternative placement al-lowed us to include participants whomight otherwise have screen-failed.The number of children receiving theshoulder placement was small; futurelarger controlled trials will be neces-sarytoconfirmtheabilityoftheshoul-derplacementtodemonstratechange.Although the pamphlet alone did notresultinimprovedsleepinthissample,itandothereducationalmaterialsmaybe

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EffectsofaStandardizedPamphletonInsomniainChildrenWithAutismSpectrumDisorders

KarenW.Adkins,CindyMolloy,ShellyK.Weiss,AnnReynolds,SuzanneE.Goldman,CourtneyBurnette,TraciClemons,DianeFawkesandBethA.Malow

Pediatrics2012;130;S139DOI:10.1542/peds.2012-0900K

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Pediatric Insomnia Journal