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RECRUITING
NCT04545606
NA

Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Sponsor: University of Missouri-Columbia

View on ClinicalTrials.gov

Summary

Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 4 sessions of behavioral therapy for sleep problems followed by 4 bimonthly booster sessions. Children and their families will be randomly assigned to one of three conditions: cognitive behavioral therapy (in-person), cognitive behavioral therapy (remote), or behavioral therapy (remote). Arousal will be measured through heart-rate variability. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline (weeks 1-2 before starting the treatment), post-treatment (weeks 6-8 from baseline), 6-month follow-up, and 12-month follow-up.

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2020-09-15

Completion Date

2030-08

Last Updated

2024-03-15

Healthy Volunteers

No

Interventions

BEHAVIORAL

In-Person CBT for insomnia in children with autism

7 modules administered in-person 1. Sleep Hygiene \& Sleep Prescription 2. Bedtime Routine \& Parent Management 3. Cue Control \& Parent Management 4. Co-Sleeping \& Parents Fading out of Room 5. Circadian Education, Morning Routine, \& Relaxation 6. Cognitive Therapy Basics 7. Nighttime Fears, Anxiety, \& Nightmares

BEHAVIORAL

Remote CBT for insomnia in children with autism

7 modules administered over telehealth/videoconferencing 1. Sleep Hygiene \& Sleep Prescription 2. Bedtime Routine \& Parent Management 3. Cue Control \& Parent Management 4. Co-Sleeping \& Parents Fading out of Room 5. Circadian Education, Morning Routine, \& Relaxation 6. Cognitive Therapy Basics 7. Nighttime Fears, Anxiety, \& Nightmares

BEHAVIORAL

Remote sleep hygiene and related education (SHARE) for insomnia in children with autism

7 modules administered over telehealth/videoconferencing 1. Sleep Education 2. Sleep Architecture \& Parasomnias 3. Physical Activity \& Sleep 4. Nutrition, My Plate, \& Breathing during Sleep 5. Stress, Sleep, Dreams, \& Nightmares Connections 6. Mood, Self-Esteem, \& Sleep 7. Light \& Dark Cycle

Locations (1)

Thompson Center for Autism and Neurodevelopmental Disorders

Columbia, Missouri, United States