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Micropractices for Unhoused LGBTQ Youth

29. dubna 2026 aktualizováno: 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 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

200

Fáze

  • Raná fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • New York
      • New York, New York, Spojené státy, 10018
        • Ali Forney Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Aktivní komparátor: 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.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Acceptability (Acceptability of Intervention Measure [AIM])
Časové okno: Assessed at post-intervention (30 days) and 3-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 3-month follow-up.
Appropriateness (Intervention Appropriateness Measure [IAM])
Časové okno: Assessed at post-intervention (30 days) and 3-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 3-month follow-up.
Feasibility (Feasibility of Intervention Measure [FIM])
Časové okno: Assessed at post-intervention (30 days) and 3-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 3-month follow-up.
Intervention adherence
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Purpose in Life (Life Engagement Test [LET])
Časové okno: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale [CES-D])
Časové okno: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
Anxiety Symptoms (Generalized Anxiety Disorder-7 Scale [GAD-7])
Časové okno: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
Psychological, emotional, and social well-being (Mental Health Continuum- Short Form [MHC-SF])
Časové okno: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
Self-Esteem (Rosenberg Self-Esteem Scale [RSE])
Časové okno: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
Authenticity (Authenticity Scale)
Časové okno: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
Substance Use Risk (CRAFFT Screening Test)
Časové okno: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Likelihood of recommending the assigned activity to a friend
Časové okno: Assessed at post-intervention (30 days) and 3-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 3-month follow-up.
Participant feedback on barriers and overall experience
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Cornell University

Spolupracovníci

Mind & Life Institute

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. října 2026

Primární dokončení (Odhadovaný)

1. listopadu 2026

Dokončení studie (Odhadovaný)

1. ledna 2027

Termíny zápisu do studia

První předloženo

29. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

29. dubna 2026

První zveřejněno (Aktuální)

5. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRB0150559

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu 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.

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Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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