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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
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.
Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.
Nora Choque Olsson
Stockholm, Sverige, Sweden
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.
Time frame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up