Clinical trial NCT03624400: Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD
Official title: Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents with Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Sleep Disturbance
Insomnia
Keywords: Autism spectrum disorder
Sleep
Cognitive-behavioral treatment
Internet delivered treatment
Lead sponsor: Stockholm University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 240
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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.

Primary outcomes:
measure: Change in sleep impairment by using The Insomnia Severity Index (ISI)
timeFrame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Secondary outcomes:
measure: Sleep diaries by using Actigraphy
timeFrame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
measure: Quality of sleep by using Athens Insomnia Scale (AIS)
timeFrame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
measure: Everyday functioning by using Developmental disabilities modification of the Children's Global Assessment scale (DD-CGAS)
timeFrame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
measure: Anxiety problems by using Spence Children's Anxiety Scale
timeFrame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
measure: Emotion regulation difficulties by using The brief version of Difficulties in Emotion Regulation Scale (DERS-16)
timeFrame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Nora Choque Olsson
state: Sverige
Study officials:
affiliation: Stockholm University
name: Nora Choque Olsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.