Parent-Mediated Telehealth Intervention for Autism and Insomnia

Not yet recruiting at 2 trial locations
LL
Overseen ByLuc Lecavalier, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

LL

Luc Lecavalier, PhD

Principal Investigator

Ohio State University

CR

Cynthia R Johnson

Principal Investigator

Cleveland Clinic Center for Autism

LS

Lawrence Scahill, MSN, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 3 and 7 years old.
* Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R)
* Score of \>30 on the Parent-Rated Insomnia Scale - ASD (PAIRS) and the Clinical Global Impression Severity (CGI-S) score of Moderate or greater (\>4 score)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Sleep Parent Treatment (SPT) or Sleep Parent Education (SPE) for 10 weeks

10 weeks
5 sessions (telehealth)

Follow-up

Participants are monitored for changes in insomnia severity and overall improvement

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Sleep Parent Treatment (SPT)Experimental Treatment1 Intervention
Group II: Sleep Parent Education (SPE)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

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

Collaborator

Trials
2,103
Recruited
2,760,000+

The Cleveland Clinic

Collaborator

Trials
1,072
Recruited
1,377,000+

Ohio State University

Collaborator

Trials
891
Recruited
2,659,000+