Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD
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|ClinicalTrials.gov Identifier: NCT03624400|
Recruitment Status : Not yet recruiting
First Posted : August 10, 2018
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Sleep Disturbance Insomnia||Behavioral: Internet-based CBT-I Behavioral: Internet-based psychoeducation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents With Autism Spectrum Disorder|
|Estimated Study Start Date :||March 4, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 30, 2023|
Experimental: Internet-based CBT-I
N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I)
Behavioral: Internet-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 10 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.
Active Comparator: Internet-based psychoeducation
N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD.
Behavioral: Internet-based psychoeducation
Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 10 weeks modules.
- Change in sleep impairment by using The Insomnia Severity Index (ISI) [ Time Frame: Baseline, post intervention (10 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.
- Sleep diaries by using Actigraphy [ Time Frame: Baseline, post intervention (10 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) [ Time Frame: Baseline, post intervention (10 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) [ Time Frame: Baseline, post intervention (10 weeks), 3 months post intervention follow-up and 6 months post itnervention 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 [ Time Frame: Baseline, post intervention (10 weeks), 3 months post intervention follow-up and 6 months post itnervention 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) [ Time Frame: Baseline, post intervention (10 weeks), 3 months post intervention follow-up and 6 months post itnervention follow-up ]The DERS-16 is a brief version of self-report measure of emotion regulation difficulties.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624400
|Contact: Nora Choque Olsson, PhDfirstname.lastname@example.org|
|Contact: Markus Jansson-Fröjmark, Professoremail@example.com|
|Principal Investigator:||Nora Choque Olsson, PhD||Karolinska Institutet|