이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Micropractices for Unhoused LGBTQ Youth

2026년 9월 15일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

200

단계

  • 초기 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • New York
      • New York, New York, 미국, 10018
        • Ali Forney Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
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.
활성 비교기: 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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Intervention adherence
기간: 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])
기간: 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])
기간: 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])
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Purpose in Life (Life Engagement Test [LET])
기간: 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])
기간: 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])
기간: 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])
기간: 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])
기간: 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)
기간: 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)
기간: 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)
기간: 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.

기타 결과 측정

결과 측정
측정값 설명
기간
Participant feedback on barriers and overall experience
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2026년 11월 1일

연구 완료 (추정된)

2027년 1월 1일

연구 등록 날짜

최초 제출

2026년 4월 29일

QC 기준을 충족하는 최초 제출

2026년 4월 29일

처음 게시됨 (실제)

2026년 5월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 15일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다