Набор скоро начнётся NCT07566273

Micropractices for Unhoused LGBTQ Youth

Ранняя фаза I С лечением Well-Being (Psychological Flourishing) Internalizing Mental Health Symptoms Substance Abuse

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Mindfulness and Identity-Based Micropractice, Control Condition Micropractice.
Кому может быть актуально: Состояния в реестре: Well-Being (Psychological Flourishing), Internalizing Mental Health Symptoms, Substance Abuse. Базовые параметры: 16 лет — 26 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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.
Поведенческое 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.

Первичные конечные точки

Acceptability (Acceptability of Intervention Measure [AIM]) [Срок оценки: Assessed at post-intervention (30 days) and 3-month follow-up.]
Appropriateness (Intervention Appropriateness Measure [IAM]) [Срок оценки: Assessed at post-intervention (30 days) and 3-month follow-up.]
Feasibility (Feasibility of Intervention Measure [FIM]) [Срок оценки: Assessed at post-intervention (30 days) and 3-month follow-up.]
Intervention adherence [Срок оценки: Assessed daily during the 30-day intervention period.]

Вторичные конечные точки (7)

Purpose in Life (Life Engagement Test [LET]) [Срок оценки: Change from baseline to post-intervention (30 days), and to 3-month follow-up.]
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale [CES-D]) [Срок оценки: Change from baseline to post-intervention (30 days), and to 3-month follow-up.]
Anxiety Symptoms (Generalized Anxiety Disorder-7 Scale [GAD-7]) [Срок оценки: 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]) [Срок оценки: Change from baseline to post-intervention (30 days), and to 3-month follow-up.]
Self-Esteem (Rosenberg Self-Esteem Scale [RSE]) [Срок оценки: Change from baseline to post-intervention (30 days), and to 3-month follow-up.]
Authenticity (Authenticity Scale) [Срок оценки: Change from baseline to post-intervention (30 days), and to 3-month follow-up.]
Substance Use Risk (CRAFFT Screening Test) [Срок оценки: Change from baseline to post-intervention (30 days), and to 3-month follow-up.]

Критерии участия

Критерии включения

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