Targeting Insomnia in School Aged Children With Autism Spectrum Disorder — RECHArge  

Autism Spectrum Disorder Clinical Trial

Official title: Targeting Insomnia in School Aged Children With Autism Spectrum Disorder

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Children with autism often have difficulties falling and staying asleep at night. Those sleep difficulties can contribute to daytime problems with irritability, learning, and behavior. Parents are often stressed about their child's sleep difficulties and as a result, their sleep can suffer as well. Treatment that focuses on establishing behaviors and routines that help reduce arousal and support good sleep are helpful for improving the sleep of children without autism, but have not yet been tested in children with autism.

Previous studies have indicated that distance can make it difficult for families to participate in treatment. As such, we will conduct treatment remotely for two of treatment arms. Having remote versions of the treatment can expand the number of children and families that are able to receive these promising treatments. This may be particularly important for children with ASD living in rural and underserved areas as well as those in military families that may not have access to a healthcare provider with training in behavioral sleep treatments. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT04545606
• Study type: Interventional
• Source: University of Missouri-Columbia
• Contact: Melanie Stearns, PhD
• Phone: 859-327-7762
• Email: mastearns@health.missouri.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Completion date: August 2030