Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

ConditionInsomnia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3-7

SponsorEmory University

About this trial

This study will evaluate the efficacy of a structured parent-mediated behavioral intervention called Sleep Parent Treatment (SPT) for insomnia in autistic children ages 3 to 7 years 11 months, compared to another behavioral intervention called Sleep Parent Education (SPE). Eligible children will be randomly assigned to either the SPT or SPE intervention for 10 weeks.

Eligibility criteria

Qualifiers

Age >3 to 7 years 11 months

Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R)

Score of 30 or more on the Parent-Rated Insomnia Scale - ASD (PAIRS) and the Clinical Global Impression Severity (CGI-S) score of Moderate or greater (a score of 4 or more)

Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 10 weeks of the randomized trial)

Disqualifiers

Children with a history of serious medical condition or known medical cause insomnia (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation)

Children with a psychiatric disorder or serious behavioral problem requiring a different treatment

Children with known sleep apnea, restless leg syndrome, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)

Children of non-English language speaking caregivers will be excluded because study intervention materials and many of the study measures are only available in English

Trial design

Treatments tested in this trial

Sleep Parent Training (SPT)
Sleep Parent Education (SPE)

Treatment groups

130 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

The Cleveland Clinic

Collaborator

Ohio State University

Collaborator

Source ClinicalTrials.gov