Developing and Evaluating Collaboratively Designed Mindfulness and Identity-Affirming Practices for Unhoused LGBTQ Youth
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Cornell University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Acceptability (Acceptability of Intervention Measure [AIM])
Study Overview
Brief Summary
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.
Detailed Description
Specific Aim 1: Evaluate the feasibility and acceptability of delivering co-designed mindfulness and identity-based micropractices to LGBTQ youth receiving shelter or services from an LGBTQ youth-serving organization over a 30-day period.
Hypothesis 1: Participants assigned to the mindfulness and identity-based micropractice condition will demonstrate higher overall adherence across the 30-day intervention period and report greater acceptability, appropriateness, and feasibility at post-intervention and one-month post-intervention follow-up than participants assigned to the active control condition.
Specific Aim 2: Determine whether the mindfulness and identity-based micropractice condition, relative to the active control condition, improves psychosocial functioning and daily affect.
Hypothesis 2: Participants assigned to the mindfulness and identity-based micropractice condition will show greater increases in purpose in life, psychological, emotional, and social well-being, self-esteem, and authentic living, and greater reductions in self-alienation, depressive symptoms, anxiety symptoms, and substance use risk from baseline to post-intervention and one-month post-intervention follow-up than participants assigned to the active control condition. Participants in the intervention condition are also expected to report more favorable outcomes than participants in the active control condition at both follow-up assessments.
Hypothesis 3: Participants assigned to the mindfulness and identity-based micropractice condition will report higher average daily positive affect and lower average daily negative affect across the 30-day intervention period than participants assigned to the active control condition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to 26 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 16 to 26 years
- •Self-identify as LGBTQ
- •Currently or recently received services from an LGBTQ community organization (within the past six months)
- •Have access to a mobile device with internet capability to complete study activities
Exclusion Criteria
- •Unable to complete study procedures (e.g., lack of device access)
Arms & Interventions
Mindfulness and Identity Condition
Participants will be assigned to complete a brief daily micropractice that integrates mindfulness (e.g., attention to breathing or present-moment awareness) with reflection on personally meaningful aspects of identity. The micropractice is delivered via a mobile-accessible platform over a 30-day period.
Intervention: Mindfulness and Identity-Based Micropractice (Behavioral)
Control Condition
Participants will be assigned to complete a brief daily activity matched in structure, duration, and delivery format, but without mindfulness or identity-based content. Activities focus on neutral reflections (e.g., daily routines or surroundings) and are delivered via a mobile-accessible platform over a 30-day period.
Intervention: Control Condition Micropractice (Behavioral)
Outcomes
Primary Outcomes
Acceptability (Acceptability of Intervention Measure [AIM])
Time Frame: Assessed at post-intervention (30 days) and 1-month follow-up.
Assessed using four items measuring participant-reported implementation outcome items evaluating approval, liking, and overall acceptance of the assigned activity. Responses are given on a 5-point Likert scale. Higher scores indicate greater acceptability.
Appropriateness (Intervention Appropriateness Measure [IAM])
Time Frame: Assessed at post-intervention (30 days) and 1-month follow-up.
Assessed using four items measuring participant-reported implementation outcome items evaluating whether the assigned activity seems relevant, fitting, and compatible with participants' lives. Responses are given on a 5-point Likert scale. Higher scores indicate greater appropriateness.
Feasibility (Feasibility of Intervention Measure [FIM])
Time Frame: Assessed at post-intervention (30 days) and 1-month follow-up.
Assessed using four items measuring participant-reported implementation outcome items evaluating whether the assigned activity seems workable, possible, and easy to do in daily life. Responses are given on a 5-point Likert scale. Higher scores indicate greater feasibility.
Secondary Outcomes
- Purpose in Life (Life Engagement Test [LET])(Change from baseline to post-intervention (30 days), and to 1-month follow-up.)
- Depressive Symptoms (Center for Epidemiologic Studies Depression Scale [CES-D])(Change from baseline to post-intervention (30 days), and to 1-month follow-up.)
- Anxiety Symptoms (Generalized Anxiety Disorder-7 Scale [GAD-7])(Change from baseline to post-intervention (30 days), and to 1-month follow-up.)
- Psychological, emotional, and social well-being (Mental Health Continuum- Short Form [MHC-SF])(Change from baseline to post-intervention (30 days), and to 1-month follow-up.)
- Self-Esteem (Rosenberg Self-Esteem Scale [RSE])(Change from baseline to post-intervention (30 days), and to 1-month follow-up.)
- Authenticity (Authenticity Scale)(Change from baseline to post-intervention (30 days), and to 1-month follow-up.)
- Substance Use Risk (CRAFFT Screening Test)(Change from baseline to post-intervention (30 days), and to 1-month follow-up.)
- Daily Mood (PANAS-C)(Assessed daily across the 30-day intervention period.)