Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD

Autism Spectrum Disorder Clinical Trial

Official title:

Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents With Autism Spectrum Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03624400
• Other study ID #: Sleep Good Autism
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: November 2023
• Source: Stockholm University
• Contact: Nora Choque Olsson, PhD
• Phone: +46703788827
• Email: nora.choque-olsson[@]psychology.su.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Dyssomnias
• Insomnia
• Parasomnias
• Sleep Disturbance

Intervention

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 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
Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.

Locations

Country	Name	City	State
Sweden	Nora Choque Olsson	Stockholm	Sverige

Sponsors (1)

Lead Sponsor	Collaborator
Stockholm University

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Quality of sleep by using Athens Insomnia Scale (AIS)	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
Secondary	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
Secondary	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
Secondary	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