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Micropractices for Unhoused LGBTQ Youth

15 settembre 2026 aggiornato da: Cornell University

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 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Hypothesis 4: Participants assigned to the mindfulness and identity-based micropractice condition will show greater increases in daily positive affect and greater decreases in daily negative affect across the 30-day intervention period than participants assigned to the active control condition.

Specific Aim 3: Examine whether engagement with the assigned daily activity is associated with changes in psychosocial outcomes and whether these associations differ by intervention condition.

Hypothesis 5: Greater adherence to the assigned daily activity will be associated with greater improvements in well-being and greater reductions in psychological distress from baseline to post-intervention and one-month post-intervention follow-up, with stronger associations expected in the mindfulness and identity-based micropractice condition than in the active control condition.

Hypothesis 6: Associations between daily activity completion and affect will be stronger in the mindfulness and identity-based micropractice condition than in the active control condition. Daily activity completion will be more strongly associated with higher same-day positive affect and lower same-day negative affect in the intervention condition, and greater overall adherence across the 30-day intervention period will be more strongly associated with higher average positive affect and lower average negative affect.

Exploratory Aim: Characterize participants' experiences with the assigned daily activity, including perceived benefits, challenges, relevance, and barriers to engagement. Open-ended responses collected during the study will be examined qualitatively to identify recurring patterns in participants' experiences with the intervention and active control activities.

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Prima fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • New York
      • New York, New York, Stati Uniti, 10018
        • Ali Forney Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

Sì

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intervention adherence
Lasso di tempo: Assessed daily during the 30-day intervention period.
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.
Acceptability (Acceptability of Intervention Measure [AIM])
Lasso di tempo: 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.
Assessed at post-intervention (30 days) and 1-month follow-up.
Appropriateness (Intervention Appropriateness Measure [IAM])
Lasso di tempo: 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.
Assessed at post-intervention (30 days) and 1-month follow-up.
Feasibility (Feasibility of Intervention Measure [FIM])
Lasso di tempo: 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.
Assessed at post-intervention (30 days) and 1-month follow-up.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Purpose in Life (Life Engagement Test [LET])
Lasso di tempo: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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 1-month follow-up.
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale [CES-D])
Lasso di tempo: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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 1-month follow-up.
Anxiety Symptoms (Generalized Anxiety Disorder-7 Scale [GAD-7])
Lasso di tempo: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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 1-month follow-up.
Psychological, emotional, and social well-being (Mental Health Continuum- Short Form [MHC-SF])
Lasso di tempo: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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 1-month follow-up.
Self-Esteem (Rosenberg Self-Esteem Scale [RSE])
Lasso di tempo: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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 1-month follow-up.
Authenticity (Authenticity Scale)
Lasso di tempo: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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 1-month follow-up.
Substance Use Risk (CRAFFT Screening Test)
Lasso di tempo: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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 1-month follow-up.
Daily Mood (PANAS-C)
Lasso di tempo: Assessed daily across the 30-day intervention period.
Assessed using 10 items measuring positive and negative affect throughout the day. Responses are given on a 5-point Likert scale. Higher positive affect scores and lower negative affect scores indicate better outcomes.
Assessed daily across the 30-day intervention period.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant feedback on barriers and overall experience
Lasso di tempo: Assessed during the 30-day intervention period.
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.
Likelihood of recommending the assigned activity to a friend
Lasso di tempo: Assessed at post-intervention (30 days) and 1-month follow-up.
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 1-month follow-up.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cornell University

Collaboratori

Mind & Life Institute

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB0150559

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

As this study involves community-based work with a marginalized population, we want to ensure that researchers accurately represent the population in future research.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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