Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents with Autism Spectrum Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Stockholm University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Change in sleep impairment by using The Insomnia Severity Index (ISI)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Nora Choque Olsson
PhD, Principal investigator
Stockholm University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in sleep impairment by using The Insomnia Severity Index (ISI)
Time Frame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
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.
Secondary Outcomes
- Sleep diaries by using Actigraphy(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)(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)(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)(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(Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up)