Micropractices for Unhoused LGBTQ Youth
29 de abril de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
200
Estágio
- Fase inicial 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10018
- Ali Forney Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Acceptability (Acceptability of Intervention Measure [AIM])
Prazo: Assessed at post-intervention (30 days) and 3-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 3-month follow-up.
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Appropriateness (Intervention Appropriateness Measure [IAM])
Prazo: Assessed at post-intervention (30 days) and 3-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 3-month follow-up.
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Feasibility (Feasibility of Intervention Measure [FIM])
Prazo: Assessed at post-intervention (30 days) and 3-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 3-month follow-up.
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Intervention adherence
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Purpose in Life (Life Engagement Test [LET])
Prazo: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
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Depressive Symptoms (Center for Epidemiologic Studies Depression Scale [CES-D])
Prazo: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
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Anxiety Symptoms (Generalized Anxiety Disorder-7 Scale [GAD-7])
Prazo: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
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Psychological, emotional, and social well-being (Mental Health Continuum- Short Form [MHC-SF])
Prazo: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
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Self-Esteem (Rosenberg Self-Esteem Scale [RSE])
Prazo: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
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Authenticity (Authenticity Scale)
Prazo: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
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Substance Use Risk (CRAFFT Screening Test)
Prazo: Change from baseline to post-intervention (30 days), and to 3-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 3-month follow-up.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Likelihood of recommending the assigned activity to a friend
Prazo: Assessed at post-intervention (30 days) and 3-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 3-month follow-up.
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Participant feedback on barriers and overall experience
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
1 de novembro de 2026
Conclusão do estudo (Estimado)
1 de janeiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
29 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2026
Primeira postagem (Real)
5 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB0150559
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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