NCT03668873

Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 2 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

Study Design: Ninety children with Autism Spectrum Disorder (ASD), between the ages of 2 to less than 7 years, and their parents will be recruited for this 10 week randomized clinical trial. Participants will be randomized to five individually delivered sessions of Sleep Parent Training (SPT) or five individually delivered sessions of Sleep Parent Education (SPE). Delivery of the programs will be via telehealth platform which also includes parent-child coaching in real-time. In addition to baseline, outcome measures will be collected at week 5 (midpoint of trial) and week 10 (endpoint of trial) as well as follow-up at week 16 to determine durability of treatment.

Detailed description

This study will deliver an already initially tested manualized parent training program specially targeting bedtime and sleep disturbances, but delivered via telehealth platform and enhancing the program using live parent coaching at bedtime. Utilizing REDCap automated survey invitations feature, investigators will provide reminders of the intervention recommendations and data collection requirements. In a randomized clinical trial of 90 children with ASD, ages 2 to less than 7 years, a parent training program targeting sleep disturbance (Sleep Parent Training; SPT), will be compared to Sleep Parent Education (SPE). The investigators hypothesize that SPT will be superior in improving child sleep, child daytime functioning as well as parent well-being compared to SPE. Specific Aims: Aim 1. To evaluate the efficacy of Sleep Parent Training program (SPT) delivered via telehealth for sleep disturbances compared Sleep Parent Educational Program (SPE, time and attention control) also delivered via telehealth in 90 children with ASD (ages \>2 to \<7 years) with moderate or greater sleep disturbances as measured by the Composite Sleep Index (CSI) of the modified Simonds and Parraga Sleep Questionnaire (MSPSQ).97 Aim 2. To evaluate the impact of SPT on child and parent quality of life (daytime child behavior, parental stress, parent sense of competency, mental health) compared to SPE.

Conditions

• Autism Spectrum Disorder
• Sleep Disturbance

Interventions

Type	Name	Description
BEHAVIORAL	Sleep Parent Training	SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.
BEHAVIORAL	Sleep Parent Education	SPE is a structured program intended to mimic treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.

Timeline

• Start date: 2018-11-01
• Primary completion: 2022-11-20
• Completion: 2022-12-26
• First posted: 2018-09-13
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States