Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

Study Overview
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Brief Summary
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This trial investigates the behavioural effects of Internet-based Cognitive behaviour therapy for insomnia (CBT-I) in adolescents with autism spectrum disorder with sleep problems. This is a randomised controlled trial.

Detailed Description
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Sleep problems are common in adolescents with autism spectrum disorder (ASD)1. Internet-based Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia 2. To date, no Internet-based CBT-I delivered treatment for sleep problems in adolescents with ASD has been undertaken. The objective of the study is to investigate the efficacy and effectiveness of the Internet-based CBT-I for sleep problems in adolescents with ASD.

Official Title
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Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents With Autism Spectrum Disorder

Conditions
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Sleep Disturbance, Autism Spectrum Disorder, Insomnia

Intervention / Treatment
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* Behavioral: Internet-based CBT-I
* Behavioral: Internet-based psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents with a clinical ASD diagnosis based on the Diagnostic and Statistical Manual-fifth edition (DSM-5). Participants have been investigated with the Autism Diagnostic Observation Schedule (ADOS). Insomnia diagnosis or sleep problems according to DSM-5 Intelligence quotient (IQ) > 70 according to Wechsler Intelligence Scale for Children - fourth edition Psychiatric comorbidities according to DSM-5: anxiety disorders or depression. Exclusion Criteria: The presence of clinically assessed self-injury High risk of suicidal behaviour borderline personality disorder or any form of schizophrenia or related disorders; substance abuse as well as physical illness or condition that was largely influence sleep condition.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based CBT-I<br>N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I) | Behavioral: Internet-based CBT-I<br>* The adapted Internet-based CBT-I for adolescents with ASD includes sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. The treatment consists of 8 weekly modules and each module consists of several website pages that will be presented in a fixed order, with preprogrammed modules containing information, interactive questionnaires, descriptions of exercises and movies.<br>|
| Active Comparator: Internet-based psychoeducation<br>N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD. | Behavioral: Internet-based psychoeducation<br>* Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep impairment by using The Insomnia Severity Index (ISI) | The ISI is a seven-item measure that yields a quantitative index of sleep impairment and treatment outcome. Participants rate the following components on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely): (a) severity of sleep-onset, sleep-maintenance, and early morning awakening problems; (b) satisfaction with current sleep pattern; (c) interference with daily functioning; (d) noticeability of impairment attributed to the sleep problem; and (e) level of distress caused by the sleep problem. Total scores range from 0 to 28, with higher scores indicating greater perceived insomnia severity. | Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep diaries by using Actigraphy | An actigraph is a small instrument worn on the wrist or ankle to measure body movement and nighttime sleep parameters. | Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up | 
| Quality of sleep by using Athens Insomnia Scale (AIS) | AIS is a self-administered questionnaire assessing the quality of sleep. | Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up | 
| Everyday functioning by using Developmental disabilities modification of the Children's Global Assessment scale (DD-CGAS) | The DD-CGAS is an instrument used by clinicians to rate patients' global everyday functioning. | Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up | 
| Anxiety problems by using Spence Children's Anxiety Scale | The SCAS is a 38-item parent report measure of children's anxiety. | Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up | 
| Emotion regulation difficulties by using The brief version of Difficulties in Emotion Regulation Scale (DERS-16) | The DERS-16 is a brief version of self-report measure of emotion regulation difficulties. | Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism spectrum disorder, Sleep, Cognitive-behavioral treatment, Internet delivered treatment