An interventional study of Internet-based CBT-I and Internet-based psychoeducation in Autism Spectrum Disorder, Sleep Disturbance and Insomnia, sponsored by Stockholm University. Not yet recruiting at 1 site in Sweden. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Stockholm University · Not applicable, Interventional, and Treatment
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 240 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Stockholm University is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I)
Behavioral: Internet-based CBT-I
N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD.
Behavioral: Internet-based psychoeducation
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.
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.
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
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Stockholm University