Autism Spectrum Disorder, Insomnia, Sleep Disturbance
Conditions
Keywords
Autism spectrum disorder, Sleep, Cognitive-behavioral treatment, Internet delivered treatment
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.
Interventions
BEHAVIORALInternet-based CBT-I
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.
BEHAVIORALInternet-based psychoeducation
Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.
Sponsors
Stockholm University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep impairment by using The Insomnia Severity Index (ISI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep diaries by using Actigraphy | Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up | An actigraph is a small instrument worn on the wrist or ankle to measure body movement and nighttime sleep parameters. |
| 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 | AIS is a self-administered questionnaire assessing the quality of sleep. |
| 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 | The DD-CGAS is an instrument used by clinicians to rate patients' global everyday functioning. |
| 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 | The SCAS is a 38-item parent report measure of children's anxiety. |
| 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 | The DERS-16 is a brief version of self-report measure of emotion regulation difficulties. |
Countries
Sweden
Contacts
Primary ContactNora Choque Olsson, PhD
Backup ContactMarkus Jansson-Fröjmark, Professor
Outcome results
None listed