- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07566273
Micropractices for Unhoused LGBTQ Youth
Developing and Evaluating Collaboratively Designed Mindfulness and Identity-Affirming Practices for Unhoused LGBTQ Youth
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Raná fáze 1
Kontakty a umístění
Studijní místa
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New York
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New York, New York, Spojené státy, 10018
- Ali Forney Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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)
Studijní plán
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 |
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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.
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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.
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Intervention adherence
Časové okno: Assessed daily during the 30-day intervention period.
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Assessed by self-reported completion of the assigned daily activity during the 30-day intervention period.
Higher adherence indicates a better outcome.
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Assessed daily during the 30-day intervention period.
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Acceptability (Acceptability of Intervention Measure [AIM])
Časové okno: Assessed at post-intervention (30 days) and 1-month follow-up.
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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.
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Assessed at post-intervention (30 days) and 1-month follow-up.
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Appropriateness (Intervention Appropriateness Measure [IAM])
Časové okno: Assessed at post-intervention (30 days) and 1-month follow-up.
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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.
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Assessed at post-intervention (30 days) and 1-month follow-up.
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Feasibility (Feasibility of Intervention Measure [FIM])
Časové okno: Assessed at post-intervention (30 days) and 1-month follow-up.
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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.
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Assessed at post-intervention (30 days) and 1-month follow-up.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Purpose in Life (Life Engagement Test [LET])
Časové okno: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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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.
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Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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Depressive Symptoms (Center for Epidemiologic Studies Depression Scale [CES-D])
Časové okno: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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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.
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Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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Anxiety Symptoms (Generalized Anxiety Disorder-7 Scale [GAD-7])
Časové okno: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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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.
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Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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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 1-month follow-up.
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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.
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Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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Self-Esteem (Rosenberg Self-Esteem Scale [RSE])
Časové okno: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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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.
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Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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Authenticity (Authenticity Scale)
Časové okno: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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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.
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Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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Substance Use Risk (CRAFFT Screening Test)
Časové okno: Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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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.
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Change from baseline to post-intervention (30 days), and to 1-month follow-up.
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Daily Mood (PANAS-C)
Časové okno: Assessed daily across the 30-day intervention period.
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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.
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Assessed daily across the 30-day intervention period.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Participant feedback on barriers and overall experience
Časové okno: Assessed during the 30-day intervention period.
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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.
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Assessed during the 30-day intervention period.
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Likelihood of recommending the assigned activity to a friend
Časové okno: Assessed at post-intervention (30 days) and 1-month follow-up.
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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.
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Assessed at post-intervention (30 days) and 1-month follow-up.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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