Autism Spectrum DisorderNCT03624400
Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD
A study testing Internet-based CBT-I and Internet-based psychoeducation in people with Autism Spectrum Disorder and Sleep Disturbance, run by Stockholm University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder, Sleep Disturbance, Insomnia
- What is being tested?
- Internet-based CBT-I and Internet-based psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2025to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Markus Jansson-Fröjmark, Professor contact
Sweden1 site
Nora Choque Olsson
Stockholm, Sverige
Nora Choque Olsson, PhD
Markus Jansson-Fröjmark, PhD
About this study
Official title: Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents with Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Sleep Disturbance, Insomnia
- Being tested
- Internet-based CBT-I, Internet-based psychoeducation
- Keywords
- Autism spectrum disorder, Sleep, Cognitive-behavioral treatment, Internet delivered treatment
- Medical subject headings
- Autism Spectrum Disorder, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based CBT-IBehavioural
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 psychoeducationBehavioural
Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based CBT-I | Experimental | N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I) Receives: Behavioral: Internet-based CBT-I |
| Internet-based psychoeducation | Active comparator | N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD. Receives: Behavioral: Internet-based psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Secondary outcomes (5)
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.
Measured: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Quality of sleep by using Athens Insomnia Scale (AIS)
AIS is a self-administered questionnaire assessing the quality of sleep.
Measured: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
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.
Measured: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Anxiety problems by using Spence Children's Anxiety Scale
The SCAS is a 38-item parent report measure of children's anxiety.
Measured: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
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.
Measured: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start15 Jan 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Choque Olsson, Stockholm University
- Investigators
- Nora Choque Olsson, PhD, Principal investigator, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624400
- Sponsor's protocol ID
- Sleep Good Autism
- Status last verified
- Nov 2024
- First submitted
- 23 Jun 2018
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18710669Bastien 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.
PubMed 15301650Georen 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.
PubMed 35651733
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents with Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03624400
- Acronym / sponsor ID
- Sleep Good Autism
- Conditions
- Autism Spectrum Disorder, Sleep Disturbance, Insomnia
- Keywords
- Autism spectrum disorder, Sleep, Cognitive-behavioral treatment, Internet delivered treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based CBT-I | Experimental | Behavioral: Internet-based CBT-IN= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I) |
| Internet-based psychoeducation | Active comparator | Behavioral: Internet-based psychoeducationN= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based CBT-IThe 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. | Behavioural | Internet-based CBT-I |
| Internet-based psychoeducationInternet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules. | Behavioural | Internet-based psychoeducation |
Primary outcome
Change in sleep impairment by using The Insomnia Severity Index (ISI)
Time frame: Baseline, post intervention (8 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.
5 secondary outcomes
Sleep diaries by using Actigraphy
Time frame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Quality of sleep by using Athens Insomnia Scale (AIS)
Time frame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Everyday functioning by using Developmental disabilities modification of the Children's Global Assessment scale (DD-CGAS)
Time frame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Anxiety problems by using Spence Children's Anxiety Scale
Time frame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Emotion regulation difficulties by using The brief version of Difficulties in Emotion Regulation Scale (DERS-16)
Time frame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 18710669Owens 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.
- Background: PubMed 15301650Bastien 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.
- Background: PubMed 35651733Georen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markus Jansson-Fröjmark, Professor contact
Nora Choque Olsson, PhD principal investigator
Stockholm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based CBT-I and Internet-based psychoeducation in people with Autism Spectrum Disorder and Sleep Disturbance, run by Stockholm University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora Choque Olsson, PhD (+46703788827, nora.choque-olsson@psychology.su.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep impairment by using The Insomnia Severity Index (ISI) (time frame: Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624400, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.