Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT04545606
Brief 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.
Detailed 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.
Study:
NCT04545606
Study Brief:
Protocol Section:
NCT04545606