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Micropractices for Unhoused LGBTQ Youth

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 213 words
    • Collaborators: details revised at 1 of 1 entry
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In the present study, the investigators will conduct a pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of brief, co-designed mindfulness and identity-affirming micropractices for LGBTQ youth and young adults experiencing housing instability. Participants (n = 200, accounting for anticipated attrition) will be randomly assigned to one of two conditions: (1) a mindfulness and identity-based micropractice condition or (2) a structurally equivalent neutral control condition. The intervention content will be developed using a participatory co-design process with members of the target population and standardized prior to trial implementation. The mindfulness and identity condition integrates brief practices targeting present-moment awareness and identity affirmation, whereas the control condition accounts for time and attention without including these components. Assessments will be conducted at baseline, post-intervention, and one-month follow-up. Primary outcomes include feasibility and acceptability, assessed using standardized implementation outcome measures and indicators of intervention adherence. Secondary outcomes include changes in mental health symptoms, psychological and emotional well-being, and substance use. The investigators will evaluate whether the mindfulness and identity-based condition demonstrates greater improvements in outcomes compared to the control condition and will estimate effect sizes to inform the design of future fully powered trials. The intervention will be delivered via a mobile-accessible platform.
Trial Details
NCT Number NCT07566273
Lead Sponsor Cornell University
Collaborators: Mind & Life Institute
Conditions
(from sponsor)
Well-Being (Psychological Flourishing), Internalizing Mental Health Symptoms, Substance Abuse
Related terms Substance-Related Disorders
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov