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

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder, Sleep Disturbance

In brief

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.

Key facts

Study ID

NCT03668873

Run by

The Cleveland Clinic

People needed

91

Starts

2018-11-01

Expected to finish

2022-12-26

Last updated by the study team

2024-09-19

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Both genders >2 and <7 years of age
• Clinical diagnosis of ASD corroborated by the Modified Checklist for Autism in Toddlers169 or the Social Communication Questionnaire.170
• Score of >5 on the CSI and a Clinical Global Impression Severity (CGI-S) score of Moderate or greater.
• Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 16 weeks).
• Parental proficiency in spoken and written English language.

You may not qualify if…

• Children with a serious medical condition or a known or suspected medical cause for sleep disturbances (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation).
• Children with a psychiatric disorder or serious behavioral problems requiring immediate treatment.
• Children with known or suspected sleep apnea, restless legs, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g. delayed or advanced sleep phase syndrome) based on history and all available information.

Where it is running

• Cleveland Clinic Centerl for Autism — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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