Targeting Sleep in Kids With Autism Spectrum Disorder

NCT ID: NCT02755051

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-03-31

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. 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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-CI-A Therapy

Participants in this group receive Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder (CBT-CI-A)

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: 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

Interventions

Cognitive Behavioral Therapy

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

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT-CI-A

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Christina McCrae

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina S McCrae, Ph. D

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

Department of Health Psychology, University of Missouri-Columbia

Columbia, Missouri, United States

Countries

United States

Other Identifiers

2004675

Identifier Type: -

Identifier Source: org_study_id