Autism Spectrum DisorderNCT02755051
Targeting Sleep in Kids With Autism Spectrum Disorder
A study testing Cognitive Behavioral Therapy in people with Autism Spectrum Disorder and Chronic Insomnia, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 8 sessions of Cognitive Behavioral Therapy designed for Children with Chronic Insomnia and ASD (CBT-CI-A). Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Chronic Insomnia
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- previous Diagnostic and Statistical Manual of Mental Disorders diagnosis of Autism Spectrum Disorder, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).
- Who have IQ>75.
- Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night >30 minutes that is confirmed by baseline sleep diaries.
- Participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level.
Who cannot join
- unable to provide informed consent
- unable to implement treatment due to sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI >15], Periodic Limb Movement Disorder (PLMD [myoclonus arousals per hour >15])
- bipolar or seizure disorder (due to risk of sleep restriction treatment)
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health Psychology, University of Missouri-Columbia
Columbia, Missouri, 65203
About this study
Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 8 sessions of Cognitive Behavioral Therapy designed for Children with Chronic Insomnia and ASD (CBT-CI-A). Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Treatment enactment will be assessed throughout treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month follow-up.
Study Flow:
Read more
Baseline (wk1-2) ---> CBT-CI-A (wk3-10) ---> Post-Treatment (wk11-12) --->Wks 13-16 --->Follow-up (wk 17-18)
Session:
- Sleep education
- Sleep scheduling, limit setting, and stimulus control
- Teaching relaxation strategies and other adaptive coping skills
- Parenting strategies (differential attention, rewards, consequences)
- Identification of maladaptive \& adaptive cognitions
- Problem solving \& communication skills
- Sleep restriction; bright light to change circadian rhythms
- Review gains and plan for long-term maintenance
Read the detailed description
Children with ASD and insomnia, and their parent(s) will undergo 8 sessions of CBT-CI-A. Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Treatment enactment will be assessed throughout treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month follow-up.
Children (6-12 yrs; n = 30) who meet full DSM (Diagnostic and Statistical Manual) criteria18 for ASD and insomnia will be recruited from an existing clinical registry database. Eligibility criteria for initial recruitment will include IQ (intelligence quotient) of 75 or above (to ensure ability to participate in cognitive components of treatment), previous DSM diagnosis of ASD, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).28 The Thompson Center database currently includes 337 children with ASD ages 6-12 who have completed the ADOS and/or ADIR and have IQ>75. Following initial recruitment, eligibility for participation will include DSM diagnosis of insomnia. Insomnia will be diagnosed by study staff using gold standard diagnostic tools, a brief (10 min.) structured interview, Child Sleep Habits Questionnaire29, and sleep diaries.30 Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night >30 minutes that is confirmed by baseline sleep diaries. Dr. Sahota will provide referrals for children with suspected sleep apnea. Additional criteria will include participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level. Given previous experience, size of the database and insomnia prevalence in ASD, the investigators expect no difficulty recruiting our target sample size.
Treatment will be manualized and individually administered by graduate students trained by Drs. McCrae and Mazurek. Parent and child will be actively involved in treatment.
CBT-CI-A will use established behavioral sleep strategies.5-7 Treatment will be adapted from a manualized protocol developed and tested by Dr. McCrae in TD children. Adaptations for children with ASD will be based on Dr. Mazurek's experience and expertise, practice pathway recommendations of the ATN, and previously published CBT adaptations for treatment of anxiety in children with ASD. Adaptations will include increased use of visual supports, greater opportunities for repetition/practice, incorporation of special interests, and video modeling.
- Conditions
- Autism Spectrum Disorder, Chronic Insomnia
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Autism Spectrum Disorder, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT-CI-A
Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder involves 8, one-hour sessions of a non-drug cognitive behavioral intervention. Session content listed below:
- Sleep education
- Sleep scheduling, limit setting, and stimulus control
- Teaching relaxation strategies and other adaptive coping skills
- Parenting strategies (differential attention, rewards, consequences)
- Identification of maladaptive \& adaptive cognitions
- Problem solving \& communication skills
- Sleep restriction; bright light to change circadian rhythms
- Review gains and plan for long-term maintenance
| Study group | Role | What they receive |
|---|---|---|
| CBT-CI-A Therapy | Experimental | Participants in this group receive Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder (CBT-CI-A) Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Subjective Sleep at 12 weeks
With parental assistance, all child participants will complete daily sleep diaries each morning
Measured: Daily for 12 weeks from Baseline thru Post-treatment
Change from Baseline Objective Sleep at 12 weeks
Child participants will wear an actigraph all day for those weeks
Measured: Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment
Change from Baseline Subjective Sleep at 18 weeks
With parental assistance, all child participants will complete daily sleep diaries each morning
Measured: Daily 18 weeks from Baseline thru Follow-up
Change from Baseline Objective Sleep at 18 weeks
Child participants will wear an actigraph during those weeks
Measured: Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment and 2 weeks at Follow-up
Secondary outcomes (7)
Child Behavior at Baseline
The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors
Measured: To be completed at 2 weeks
Child Behavior at Post-treatment
The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors
Measured: To be completed at 12 weeks
Child Behavior at Follow-up
The Aberrant Behavior Checklist is a 58-item parent-report measure of daytime problem behaviors
Measured: To be completed at 18 weeks
Change in subjective Parent Sleep from Baseline at 12 weeks
Parents will complete daily sleep diaries each morning
Measured: Daily for 12 weeks from Baseline thru Post-treatment
Change in subjective Parent Sleep from Baseline at 18 weeks
Parents will complete daily sleep diaries each morning
Measured: Daily for 18 weeks from Baseline thru Follow-up
Change in objective Parent Sleep from Baseline at 12 weeks
Parents will wear an actigraph during those weeks
Measured: Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment
Change in objective Parent Sleep from Baseline at 18 weeks
Parents will wear an actigraph during those weeks
Measured: Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment, and 2 weeks at Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina McCrae, University of Missouri-Columbia
- Investigators
- Christina S McCrae, Ph. D, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755051
- Sponsor's protocol ID
- 2004675
- Status last verified
- Jul 2018
- First submitted
- 11 Mar 2016
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Sleep in Kids With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02755051
- Acronym / sponsor ID
- 2004675
- Conditions
- Autism Spectrum Disorder, Chronic Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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.
Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 8 sessions of Cognitive Behavioral Therapy designed for Children with Chronic Insomnia and ASD (CBT-CI-A). Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Treatment enactment will be assessed throughout treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month follow-up.
Study Flow:
Baseline (wk1-2) ---> CBT-CI-A (wk3-10) ---> Post-Treatment (wk11-12) --->Wks 13-16 --->Follow-up (wk 17-18)
Session:
- Sleep education
- Sleep scheduling, limit setting, and stimulus control
- Teaching relaxation strategies and other adaptive coping skills
- Parenting strategies (differential attention, rewards, consequences)
- Identification of maladaptive \& adaptive cognitions
- Problem solving \& communication skills
- Sleep restriction; bright light to change circadian rhythms
- Review gains and plan for long-term maintenance
Detailed description
Children with ASD and insomnia, and their parent(s) will undergo 8 sessions of CBT-CI-A. Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Treatment enactment will be assessed throughout treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month follow-up.
Children (6-12 yrs; n = 30) who meet full DSM (Diagnostic and Statistical Manual) criteria18 for ASD and insomnia will be recruited from an existing clinical registry database. Eligibility criteria for initial recruitment will include IQ (intelligence quotient) of 75 or above (to ensure ability to participate in cognitive components of treatment), previous DSM diagnosis of ASD, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).28 The Thompson Center database currently includes 337 children with ASD ages 6-12 who have completed the ADOS and/or ADIR and have IQ>75. Following initial recruitment, eligibility for participation will include DSM diagnosis of insomnia. Insomnia will be diagnosed by study staff using gold standard diagnostic tools, a brief (10 min.) structured interview, Child Sleep Habits Questionnaire29, and sleep diaries.30 Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night >30 minutes that is confirmed by baseline sleep diaries. Dr. Sahota will provide referrals for children with suspected sleep apnea. Additional criteria will include participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level. Given previous experience, size of the database and insomnia prevalence in ASD, the investigators expect no difficulty recruiting our target sample size.
Treatment will be manualized and individually administered by graduate students trained by Drs. McCrae and Mazurek. Parent and child will be actively involved in treatment.
CBT-CI-A will use established behavioral sleep strategies.5-7 Treatment will be adapted from a manualized protocol developed and tested by Dr. McCrae in TD children. Adaptations for children with ASD will be based on Dr. Mazurek's experience and expertise, practice pathway recommendations of the ATN, and previously published CBT adaptations for treatment of anxiety in children with ASD. Adaptations will include increased use of visual supports, greater opportunities for repetition/practice, incorporation of special interests, and video modeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT-CI-A Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyParticipants in this group receive Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder (CBT-CI-A) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- previous Diagnostic and Statistical Manual of Mental Disorders diagnosis of Autism Spectrum Disorder, and previous evaluation using gold standard diagnostic tools, including the Autism Diagnostic Observation Schedule (ADOS)27 and/or Autism Diagnostic Interview - Revised (ADI-R).
- Who have IQ>75.
- Child will report or parent will observe sleep latency (time to fall asleep) or wake during the night >30 minutes that is confirmed by baseline sleep diaries.
- Participation of the child's parent or legal guardian living in the same home, and parental ability to read and understand English at the 5th grade level.
Key exclusion criteria (4 listed)
- unable to provide informed consent
- unable to implement treatment due to sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI >15], Periodic Limb Movement Disorder (PLMD [myoclonus arousals per hour >15])
- bipolar or seizure disorder (due to risk of sleep restriction treatment)
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBT-CI-ACognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder involves 8, one-hour sessions of a non-drug cognitive behavioral intervention. Session content listed below: 1. Sleep education 2. Sleep scheduling, limit setting, and stimulus control 3. Teaching relaxation strategies and other adaptive coping skills 4. Parenting strategies (differential attention, rewards, consequences) 5. Identification of maladaptive \& adaptive cognitions 6. Problem solving \& communication skills 7. Sleep restriction; bright light to change circadian rhythms 8. Review gains and plan for long-term maintenance | Behavioural | CBT-CI-A Therapy |
Primary outcome
Change from Baseline Subjective Sleep at 12 weeks
Time frame: Daily for 12 weeks from Baseline thru Post-treatment
With parental assistance, all child participants will complete daily sleep diaries each morning
Change from Baseline Objective Sleep at 12 weeks
Time frame: Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment
Child participants will wear an actigraph all day for those weeks
Change from Baseline Subjective Sleep at 18 weeks
Time frame: Daily 18 weeks from Baseline thru Follow-up
With parental assistance, all child participants will complete daily sleep diaries each morning
Change from Baseline Objective Sleep at 18 weeks
Time frame: Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment and 2 weeks at Follow-up
Child participants will wear an actigraph during those weeks
7 secondary outcomes
Child Behavior at Baseline
Time frame: To be completed at 2 weeks
Child Behavior at Post-treatment
Time frame: To be completed at 12 weeks
Child Behavior at Follow-up
Time frame: To be completed at 18 weeks
Change in subjective Parent Sleep from Baseline at 12 weeks
Time frame: Daily for 12 weeks from Baseline thru Post-treatment
Change in subjective Parent Sleep from Baseline at 18 weeks
Time frame: Daily for 18 weeks from Baseline thru Follow-up
Change in objective Parent Sleep from Baseline at 12 weeks
Time frame: Continuously for 2 weeks at Baseline and 2 weeks at Post-treatment
Change in objective Parent Sleep from Baseline at 18 weeks
Time frame: Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment, and 2 weeks at Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christina S McCrae, Ph. D principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Autism Spectrum Disorder and Chronic Insomnia, run by University of Missouri-Columbia at 1 site in United States.
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: finished, as of the sponsor's last update on 20 Jul 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Subjective Sleep at 12 weeks (time frame: Daily for 12 weeks from Baseline thru Post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2018.