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Mindfulness-Based Substance Use Prevention (MINDS-UP)

Study acronym: MINDS-UP
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 2 of 6 changed
Enrollment reduced 11% 45 → 40 participants
See other at-risk trials from New York State Psychiatric Institute

Record History

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  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Enrollment reduced: 45 → 40 participants
    • Interventions modified
    • Trial arms changed: 3 → 2
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 12 to 15
  2. Start date: Mar 1, 2026 to Oct 1, 2026v4
  3. Primary and study completion dates: Jan 1, 2027 to Jan 1, 2028
    • Start date: Jul 1, 2025 to Mar 1, 2026
    v3
  4. Start date: Jan 1, 2025 to Jul 1, 2025v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to test the feasibility, behavioral/neural mechanisms, and preliminary efficacy of "MINDfulness-based Substance Use Prevention Program," or "MINDS-UP", a novel substance use prevention meditation intervention for children and adolescents between the ages of 10 and 14. The aims of the study are: Aim 1: Determine feasibility and acceptability of MINDS-UP as a preventive intervention via a) retention, b) attendance, c) teacher-rated participation, d) student-rated participation, e) homework completion, and f) acceptability. Aim 2: Evaluate neuropsychological mechanisms (target engagement) of MINDS-UP. Aim 3 (Exploratory): Assess preliminary efficacy of MINDS-UP on substance use initiation (SUI).
Trial Details
NCT Number NCT06593470
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Substance Use
Related terms Substance-Related Disorders
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov