Micropractices for Unhoused LGBTQ Youth
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age16-26
SponsorCornell University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Unable to complete study procedures (e.g., lack of device access)
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness and Identity-Based Micropractice
BehavioralParticipants 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.
Control Condition Micropractice
BehavioralParticipants 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Mindfulness and Identity ConditionExperimental treatment 1 intervention
Group B: Control ConditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed at post-intervention (30 days) and 1-month follow-up.2
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.
Time frame
Assessed at post-intervention (30 days) and 1-month follow-up.3
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.
Time frame
Assessed at post-intervention (30 days) and 1-month follow-up.4
Intervention adherence
Assessed by self-reported completion of the assigned daily activity during the 30-day intervention period. Higher adherence indicates a better outcome.
Time frame
Assessed daily during the 30-day intervention period.Secondary outcomes
1
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.
Time frame
Change from baseline to post-intervention (30 days), and to 1-month follow-up.2
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.
Time frame
Change from baseline to post-intervention (30 days), and to 1-month follow-up.3
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.
Time frame
Change from baseline to post-intervention (30 days), and to 1-month follow-up.4
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.
Time frame
Change from baseline to post-intervention (30 days), and to 1-month follow-up.Other outcomes
1
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.
Time frame
Assessed at post-intervention (30 days) and 1-month follow-up.2
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.
Time frame
Assessed during the 30-day intervention period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cornell University
Lead sponsor
Mind & Life Institute
Collaborator
Source ClinicalTrials.gov
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