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Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)

Study acronym: HEART
StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Interventions: Hamburg Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART (Behavioral) to Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART (Behavioral)
    • Study description revised
    • Study title revised
  2. Phase: Phase 1 to Early Phase 1v3 Show 5 more changesShow less
    • Enrollment target: 42 to 21
    • Start date: Sep 30, 2025 to Jan 15, 2026
    • Eligibility criteria shortened, about 18 words
    • Study description shortened, about 13 words
    • Study arms: 2 to 1
  3. Phase: Early Phase 1 to Phase 1v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study focuses on a group training program called HEART aimed at helping adolescents with Autism Spectrum Disorder improve emotional regulation. It will use a pilot trial to evaluate the program's feasibility and effectiveness. The findings aim to advance scientific understanding and support the development of effective, evidence-based interventions to strengthen psychosocial support for autistic adolescents.
Trial Details
NCT Number NCT07009522
Lead Sponsor Universitätsklinikum Hamburg-Eppendorf
Conditions
(from sponsor)		 Study Group
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov