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Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Sponsor changed: Emory University to The Cleveland Clinic Show 4 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study sites revised (3)
    • Collaborators: 3 to 2
  2. Recruitment opened
    • Start date changed from estimate of Jun 2026 to Jun 5, 2026
    • Site details revised at 3 of 3 sites
    v3
  3. Start date: Mar 2026 to Jun 2026
    • Enrollment reduced: 180 → 130 participants
    • Eligibility criteria expanded, about 6 words
    • Study description expanded, about 117 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07435740
Lead Sponsor The Cleveland Clinic
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ohio State University
Conditions
(from sponsor)		 Insomnia
Related terms Autistic Disorder, Sleep Initiation and Maintenance Disorders
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov