Telehealth Delivery of Treatment for Sleep Disturbances in Young Children

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03668873
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 1, 2018
Completion date	August 1, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms