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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

Tracking Information
First Submitted Date  ICMJE June 23, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date August 14, 2019
Estimated Study Start Date  ICMJE March 4, 2020
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03624400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD
Official Title  ICMJE Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents With Autism Spectrum Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism Spectrum Disorder
  • Sleep Disturbance
  • Insomnia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Internet-based CBT-I
    N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I)
    Intervention: Behavioral: Internet-based CBT-I
  • Active Comparator: Internet-based psychoeducation
    N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD.
    Intervention: Behavioral: Internet-based psychoeducation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nora Choque Olsson, PhD +46703788827 nora.choque-olsson@ki.se
Contact: Markus Jansson-Fröjmark, Professor markus.jansson-frojmark@ki.se
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03624400
Other Study ID Numbers  ICMJE Sleep Good Autism
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nora Choque Olsson, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nora Choque Olsson, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP