Micropractices for Unhoused LGBTQ Youth
Developing and Evaluating Collaboratively Designed Mindfulness and Identity-Affirming Practices for Unhoused LGBTQ Youth
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10018
- Ali Forney Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Intervention adherence
時間枠：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])
時間枠：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])
時間枠：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])
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Purpose in Life (Life Engagement Test [LET])
時間枠：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])
時間枠：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])
時間枠：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])
時間枠：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])
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Participant feedback on barriers and overall experience
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB0150559
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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