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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based CBT-I | Experimental | N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I) |
|
| Internet-based psychoeducation | Active Comparator | N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based CBT-I | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nora Choque Olsson, PhD | Contact | +46703788827 | nora.choque-olsson@psychology.su.se | |
| Markus Jansson-Fröjmark, Professor | Contact | markus.jansson-frojmark@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Nora Choque Olsson, PhD | Stockholm University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nora Choque Olsson | Stockholm | Sverige | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18710669 | Background | Owens J. Classification and epidemiology of childhood sleep disorders. Prim Care. 2008 Sep;35(3):533-46, vii. doi: 10.1016/j.pop.2008.06.003. | |
| 15301650 | Background | Bastien CH, Morin CM, Ouellet MC, Blais FC, Bouchard S. Cognitive-behavioral therapy for insomnia: comparison of individual therapy, group therapy, and telephone consultations. J Consult Clin Psychol. 2004 Aug;72(4):653-9. doi: 10.1037/0022-006X.72.4.653. |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
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|
| Internet-based psychoeducation | Behavioral | Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules. |
|
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 |
| 35651733 | Background | Georen L, Jansson-Frojmark M, Nordenstam L, Andersson G, Olsson NC. Internet-delivered Cognitive Behavioral Therapy for insomnia in youth with autism spectrum disorder: A pilot study. Internet Interv. 2022 May 23;29:100548. doi: 10.1016/j.invent.2022.100548. eCollection 2022 Sep. |
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |