Micropractices for Unhoused LGBTQ Youth

Developing and Evaluating Collaboratively Designed Mindfulness and Identity-Affirming Practices for Unhoused LGBTQ Youth

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 three-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.

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Abuse; Well-Being (Psychological Flourishing); Internalizing Mental Health Symptoms
• Intervention / Treatment: Behavioral: Mindfulness and Identity-Based Micropractice; Behavioral: Control Condition Micropractice

Detailed Description

Specific Aim 1: Evaluate the feasibility and acceptability of delivering co-designed mindfulness and identity-affirming micropractices to LGBTQ youth experiencing housing instability over a 30-day period. Hypothesis 1: Participants in the mindfulness and identity-based condition will demonstrate higher adherence (e.g., daily completion rates) and report greater acceptability compared to the neutral control condition. Specific Aim 2: Determine whether the mindfulness and identity-based micropractice condition, relative to the control condition, is associated with improvements in psychological and emotional well-being and reductions in distress and substance use. Hypothesis 2: Participants in the mindfulness and identity-based condition will show greater increases in well-being and greater reductions in anxiety, depressive symptoms, and substance use from baseline to post-intervention and to three-month follow-up compared to the control condition. Specific Aim 3: Assess whether engagement with the intervention (e.g., adherence to daily micropractices) is associated with improvements in psychosocial outcomes. Hypothesis 3: Greater engagement with the mindfulness and identity-based micropractices will be associated with greater improvements in well-being and greater reductions in distress across the study period. Exploratory Aim: Evaluate participants' experiences with the intervention, including perceived benefits, challenges, and contextual relevance of the micropractices. This aim will be addressed through qualitative feedback collected during the study period. The investigators will characterize common themes related to usability, relevance, and barriers to engagement, and will examine whether the intervention meets predefined criteria for feasibility and acceptability.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10018
      • Ali Forney Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 16 to 26 years
• Self-identify as LGBTQ
• Currently or recently experiencing housing instability (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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindfulness and Identity-Based Micropractice; Participants will complete a brief daily micropractice (approximately 1-5 minutes per day) that integrates mindfulness (e.g., attention to breathing or present-moment awareness) with reflection on personally meaningful aspects of identity. The micropractice is co-designed with members of the target population, standardized prior to the trial, and delivered via a mobile-accessible platform.
Active Comparator: 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.	Behavioral: Control Condition Micropractice; Participants will complete a brief daily activity (approximately 1-5 minutes per day) matched in structure and delivery format to the intervention condition, but without mindfulness or identity-based content. Activities include neutral reflections (e.g., daily routines or surroundings) and are delivered via a mobile-accessible platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability (Acceptability of Intervention Measure [AIM])	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.	Assessed at post-intervention (30 days) and 3-month follow-up.
Appropriateness (Intervention Appropriateness Measure [IAM])	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.	Assessed at post-intervention (30 days) and 3-month follow-up.
Feasibility (Feasibility of Intervention Measure [FIM])	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.	Assessed at post-intervention (30 days) and 3-month follow-up.
Intervention adherence	Assessed by self-reported completion of the assigned daily activity during the 30-day intervention period. Higher adherence indicates a better outcome.	Assessed daily during the 30-day intervention period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Purpose in Life (Life Engagement Test [LET])	Assessed using 6 items measuring the extent to which participants experience purpose, meaning, and value in their daily activities. Responses are given on a 5-point Likert scale. Higher scores indicate greater purpose.	Change from baseline to post-intervention (30 days), and to 3-month follow-up.
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale [CES-D])	Assessed using 10 items measuring depressive symptoms during the past week. Responses are given on a 4-point Likert scale. Higher scores indicate greater depressive symptoms. Lower scores indicate a better outcome.	Change from baseline to post-intervention (30 days), and to 3-month follow-up.
Anxiety Symptoms (Generalized Anxiety Disorder-7 Scale [GAD-7])	Assessed using 7 items measuring anxiety symptoms over the last 2 weeks. Responses are given on a 4-point Likert scale. Higher scores indicate greater anxiety symptoms. Lower scores indicate a better outcome.	Change from baseline to post-intervention (30 days), and to 3-month follow-up.
Psychological, emotional, and social well-being (Mental Health Continuum- Short Form [MHC-SF])	Assessed using 14 items measuring emotional, psychological, and social well-being during the past month. Responses are given on a 6-point Likert scale. Higher scores indicate greater well-being.	Change from baseline to post-intervention (30 days), and to 3-month follow-up.
Self-Esteem (Rosenberg Self-Esteem Scale [RSE])	Assessed using 10 items measuring global self-esteem over the past 30 days. Responses are given on a 5-point Likert scale. Higher scores indicate greater self-esteem.	Change from baseline to post-intervention (30 days), and to 3-month follow-up.
Authenticity (Authenticity Scale)	Includes two dimensions of the Authenticity Scale: Self-Alienation and Authentic Living. Self-Alienation is assessed using 4 items measuring participants' sense of being out of touch with the "real me". Higher scores indicate lower authenticity. Authentic Living is assessed using 4 items measuring participants' sense of being true to themselves, their beliefs, and values. Higher scores indicate greater authenticity. Responses are given on a 7-point Likert scale.	Change from baseline to post-intervention (30 days), and to 3-month follow-up.
Substance Use Risk (CRAFFT Screening Test)	Assessed using 11 items measuring likelihood of alcohol- and drug-related risk behaviors over the past 30 days. Responses are given on a 5-point Likert scale. Higher scores indicate greater substance use risk. Lower scores indicate a better outcome.	Change from baseline to post-intervention (30 days), and to 3-month follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likelihood of recommending the assigned activity to a friend	Assessed using a single item asking how likely participants are to recommend the assigned activity to a friend, rated from 0 to 10. Higher scores indicate greater willingness to recommend the activity.	Assessed at post-intervention (30 days) and 3-month follow-up.
Participant feedback on barriers and overall experience	Assessed using open-ended items asking participants about reasons for not completing daily activities, comments about the study, and perceived benefits or challenges related to participation. Responses will be analyzed qualitatively.	Assessed during the 30-day intervention period.

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: Mind & Life Institute

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Substance Abuse; Well-Being; LGBTQ; Micropractice; Unhoused; Internalizing Mental Health Symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness
• Other Study ID Numbers: IRB0150559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: As this study involves community-based work with a marginalized population, we want to ensure that researchers accurately represent the population in future research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No