Targeting Sleep in Kids With Autism Spectrum Disorder

NCT02755051 | Completed

• 1 other identifier: 2004675
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Sleep education
2. 2.Sleep scheduling, limit setting, and stimulus control
3. 3.Teaching relaxation strategies and other adaptive coping skills
4. 4.Parenting strategies (differential attention, rewards, consequences)
5. 5.Identification of maladaptive \& adaptive cognitions
6. 6.Problem solving \& communication skills
7. 7.Sleep restriction; bright light to change circadian rhythms
8. 8.Review gains and plan for long-term maintenance

Conditions

Autism Spectrum Disorder; Chronic Insomnia

Outcome Measures

Primary Outcomes (4)

• Change from Baseline Subjective Sleep at 12 weeks

  With parental assistance, all child participants will complete daily sleep diaries each morning

  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

  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

  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

  Continuously for 2 weeks at Baseline, 2 weeks at Post-treatment and 2 weeks at Follow-up

Secondary Outcomes (7)

• Child Behavior at Baseline

  To be completed at 2 weeks

• Child Behavior at Post-treatment

  To be completed at 12 weeks

• Child Behavior at Follow-up

  To be completed at 18 weeks

• Change in subjective Parent Sleep from Baseline at 12 weeks

  Daily for 12 weeks from Baseline thru Post-treatment

• Change in subjective Parent Sleep from Baseline at 18 weeks

  Daily for 18 weeks from Baseline thru Follow-up

Study Arms (1)

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)

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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: 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

Also known as: CBT-CI-A

CBT-CI-A Therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Department of Health Psychology, University of Missouri-Columbia

Columbia, Missouri, 65203, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christina S McCrae, Ph. D

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: April 28, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)