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The DreamChanger Intervention in Combination With Imagery Rehearsal Therapy for Children's Nightmares

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Enrollment target: estimated 120 to confirmed 126
    • Primary completion date changed from estimate of Mar 2026 to Mar 30, 2026
    • Study completion date changed from estimate of Jun 2026 to Jun 30, 2026
    • Eligibility criteria expanded, about 5 words
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Sep 2025 to Mar 2026
    • Study completion date: Dec 2025 to Jun 2026
    • Start date changed from estimate of May 2024 to May 7, 2024
    • Site details revised
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial will test the efficacy of parent-delivered DreamChanger Intervention in combination with Imagery Rehearsal Therapy (IRT) for reducing the frequency and severity of nightmares in children aged 3-10. Children will be randoimized to either the combined intervention or to a waitlist control group.The intervention will include providing children with the DreamChanger remote, and providing parents with instructional videos, explaining how to use the device along with the IRT strategy to address nightmares. At baseline, mid-treatment, and post-treatment, parents in both groups will complete questionnaires asking about the child's nightmares, sleep, externalizing and internalizing symptoms, PTSD symptoms, demographic characteristics, and parent sleep and distress. Parents in the intervention group will also be asked to complete questionnaires regarding their compliance and satisfaction with the intervention, as well as a 3-month follow-up assessment.
Trial Details
NCT Number NCT06410118
Lead Sponsor Tel Aviv University
Conditions
(from sponsor)
Nightmare
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov