Recruiting

SPT vs. SPE

Sponsor:

Emory University

Code:

NCT07435740

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

Interventions

Sleep Parent Training (SPT)

Sleep Parent Education (SPE)

Study Details

Brief summary:

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.

Conditions

Insomnia

Study ID

NCT07435740

Start date

Jun 5, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 7

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)
  • Parental proficiency in spoken and written English language. Study materials and many of the study measures are only available in English

Exclusion Criteria:

  • 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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sleep Parent Treatment (SPT)

Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Treatment (SPT) delivered over 10 weeks.

active comparator: Sleep Parent Education (SPE)

Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Education (SPE) delivered over 10 weeks.

Interventions

Sleep Parent Training (SPT)

Five SPT sessions, each 60-90 minutes in duration, are individually delivered over 10 weeks. Each session employs direct instruction, modeling, and role-playing to promote parental skill acquisition. The SPT manual includes a therapist script and parent activity sheets for each session. Video vignettes for each session model specific techniques, including correct application of a technique and ineffective strategies. To supplement the 5 sessions, three virtual parent-child coaching sessions occur to ensure implementation fidelity. A sleep plan for the child is developed with the parent and is revised, as needed, at each session.

Sleep Parent Education (SPE)

SPE includes five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and insomnia. The sessions cover a review of autism, sleep hygiene, interpretation of clinical evaluations, child advocacy and evaluation of available treatments, and information on evidence-based treatments.

Primary outcome measure

  • Pediatric Autism Insomnia Scale (PAIRS) Score [ Time Frame: Baseline, Week 5, Week 10 ]

Central Contacts and Locations

Central contacts

Cynthia Johnson, PhD

(216) 448-6440johnsoc@ccf.org

Luc Lecavalier, PhD

(614) 685-8722luc.lecavalier@osumc.edu

Locations

Emory School Of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Emory University

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • autism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-18.