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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
Sponsor:
Information provided by (Responsible Party):
Nora Choque Olsson, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Sleep Disturbance Insomnia Behavioral: Internet-based CBT-I Behavioral: Internet-based psychoeducation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Nora Choque Olsson, PhD +46703788827 nora.choque-olsson@ki.se
Contact: Markus Jansson-Fröjmark, Professor markus.jansson-frojmark@ki.se

Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Nora Choque Olsson, PhD Karolinska Institutet

Publications:
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Responsible Party: Nora Choque Olsson, PhD, Principal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03624400     History of Changes
Other Study ID Numbers: Sleep Good Autism
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nora Choque Olsson, Karolinska Institutet:
Autism spectrum disorder
Sleep
Cognitive-behavioral treatment
Internet delivered treatment
Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms