Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07435740
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 7 Years
Healthy Volunteers
Not accepted

Interventions

  • Sleep Parent Training (SPT) — BEHAVIORAL
    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) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2031

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory School Of MedicineAtlantaGeorgia30322-
Case Western Reserve UniversityClevelandOhio44106-
Ohio State UniversityColumbusOhio43210-

Find similar trials in Atlanta, GA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Emory School Of Medicine· Atlanta, GACase Western Reserve University· Cleveland, OHOhio State University· Columbus, OH

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