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The Gender Inclusive Sexuality Talks Program (GIST)

13 de setembro de 2026 atualizado por: Dalmacio Flores, University of Pennsylvania

Parents ASSIST for All LGBTQ Youth (Hillman)

The study is centered on helping parents answer and meet the sexuality-specific questions and needs of transgender, gender diverse, lesbian or bisexual female youth. This study seeks to test the efficacy of the GIST Program as a parent-child sexuality communication intervention that educates and trains parents to be purveyors of inclusive health information as transgender, gender diverse, lesbian or bisexual female youth come of age at home.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Parental acceptance after youth come out as transgender, gender diverse, lesbian or bisexual is a protective factor for the health of this youth group; however, parents lack support in initiating and sustaining sexuality discussions inclusive of their teens' attractions, behaviors and identities. Thus, in the absence of skills and supports, adolescents' and parents' mental health, health behaviors and overall family functioning tend to be negatively impacted after sons come out as gay or bisexual. The overall objective of this study is to test the efficacy of the GIST Program (Gender Inclusive Sexuality Talks), a sexuality communication intervention for parents, after youth disclose transgender, gender diverse, lesbian or bisexual identities.

We will conduct a randomized controlled trial with parent and youth dyads (N=300) to establish the efficacy of the GIST Program as a hybrid 5-session online intervention that educates parents about germane sexuality-specific topics and provide communication skills for family discussions. Our Specific Aims are to (1) determine whether the GIST Program enhances parent-adolescent sexuality communication quality (e.g. parent- and child-reported comfort) and quantity (e.g. frequency and range of topics discussed) compared to the control group, (2) establish whether the GIST Program results in decreases in mental health symptomology (e.g. depressive and anxiety symptoms) among parents and youth, increases dyadic health behavior (e.g. accessing preventive health services, health screening behaviors), and improves family functioning (e.g. affective response, communication, general functioning) over 12 months of follow-up, and (3) examine how theory-based variables (e.g. attitudes and norms, self-efficacy and intentions to discuss sexuality with transgender, gender diverse, lesbian or bisexual child) mediate the intervention effects on adolescent and parent mental health, parent-adolescent health behavior and family functioning over time.

Tipo de estudo

Intervencional

Inscrição (Estimado)

300

Estágio

  • Não aplicável

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.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Recrutamento
        • Penn Nursing
        • Contato:

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
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

Youth participants are:

identify as transgender or gender diverse, or lebian or bisexual female be between ages 12-18 years able to comprehend spoken English resides in the United States consents or assents to study participation

Parent participants are:

the parent, legal guardians, legal custodians (hereinafter "parent") of index youth age 18 or older able to comprehend spoken English resides in the United States consents to study participation consents to their child's study participation

Exclusion Criteria:

Excluded youth participants are:

non-transgender or gender diverse or lesbian or bisexual female youth

Excluded participants are:

parents whose child does not meet eligibility criteria

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 cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: GIST Intervention Arm
Parents randomized to this arm will receive five, online based group sessions.
Comportamental: The Gender Inclusive Sexuality Talks Program
The GIST Program is a 5-session intervention where an interventionist will facilitate sessions that will include 8-12 parents per group. Each parent will have access to intervention content (e.g., videos, activities) across five synchronous sessions. Session I will focus on the issue of coming out and its impact on the family as well as on youth mental health. Session II centers on communication-based content. Sessions III and IV focuses on topic-centered content to address the knowledge gap parents have reported regarding general LGBTQ concerns and builds on the communication skills learned in Session I. Session V provides a communication recap and focuses on how parents may have follow-up conversations with healthcare providers. In between the sessions, asynchronous interactive homework assignments will be provided to review concepts learned in the previous sessions and to initiate joint activities between parents and youth.
Comparador Ativo: Control Arm
Parents randomized to this arm will have individual access to an online series of five modules that they can complete at their own pace. The content for each module are LGBTQ-specific health issues such as sleep hygiene, bullying, tobacco and alcohol use, and body image concerns.
Comportamental: GIST Control
The control arm consists of access to five online modules. Parents in this condition will be able to view video content focused on health issues germane for LGBTQ youth that are not focused on sexual health. These outcomes are on bullying, alcohol and tobacco use, sleep hygiene and body image concerns.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Parent-Adolescent Communication Quantity
Prazo: Baseline, 1 week, 3 months, 6 months
The Parent- Teen Sexual Risk Communication Topic Scale will be adopted and used to measure the quantity of topics discussed. Participants are asked if they had ever discussed the topics with their child/parent, and if so, which ones. To measure quantity, sample questions would be "To what extent have you ever discussed any of the following topics with your mother/father?" Sample items: coming out/disclosure of sexual orientation, using a condom, peer pressure and sexual pressure from dating partners, penilevaginal or other types of intercourse. Response options: (1) none, (2) a little, (3) some, (4) a lot, or (5) extensive. (8 items; alpha = .85-.95)
Baseline, 1 week, 3 months, 6 months
Parent-Adolescent Communication Quality
Prazo: Baseline, 1 week, 3 months, 6 months
The quality of sexuality-sensitive communication will be determined using the Family Sexuality Communication Quotient - a measure of a general family orientation to discussion about sexuality between parents and children; this is an 18-item scale with options (1-Strongly Agree to 5-Strongly Disagree). The first subscale on comfort measures the perceived degree of openness with which sexuality is discussed in the family (e.g., I feel free to ask my parents questions about sexuality). The second subscale on information measures perception of the amount of information learned and shared during discussions (e.g., I feel better informed about sexuality if I talk to my parents.) (18 items; alpha = .91)
Baseline, 1 week, 3 months, 6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Adolescent and Parent Mental Health (Depression)
Prazo: Baseline, 1 week, 3 months, 6 months
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool. This 9-item questionnaire lists varying depression symptoms and inquires about how much each depression symptom has been noted as bothersome within the past two weeks. Response options are: (0) not at all, (1) several days a week, (2) more than half the days, (3) nearly every day. (9 items; alpha = .95)
Baseline, 1 week, 3 months, 6 months
Adolescent and Parent Mental Health (Anxiety)
Prazo: Baseline, 1 week, 3 months, 6 months
The GAD-7 is a valid and efficient tool for screening for Generalized Anxiety Disorder and assessing its severity in clinical practice and research. There was good agreement between self-report and interviewer-administered versions of the scale. This 7-item questionnaire lists varying anxiety symptoms and inquires about how much each symptom has been noted as bothersome within the past two weeks. Response options are: (0) not at all, (1) several days a week, (2) more than half the days, (3) nearly every day. (7 items; alpha = .92)
Baseline, 1 week, 3 months, 6 months
Parent-Adolescent Health Behavior (Wellness Appointment)
Prazo: Baseline, 1 week, 3 months, 6 months
We will measure successful setting up by both parent and child of screening appointments with an LGBTQ-competent provider during each follow-up survey. Three questions will asked: (1) Since the last survey, have you and your parent/child looked up LGBTQ-friendly health providers in your area? (Yes/No); (2) Since the last survey, have you and your parent/child made an appointment for a wellness appointment? (Yes/No); and (3) Since the last survey, have you and your parent/child seek out a healthcare provider to be screened for a sexually-transmitted infection? (Yes/No).
Baseline, 1 week, 3 months, 6 months
Family Functioning
Prazo: Baseline, 1 week, 3 months, 6 months
The Family Assessment Device (FAD) is based on the McMaster Model of Family Functioning (MMFF), a clinically oriented conceptualization of families. It is a screening instrument consisting of 60-items. The model identifies seven dimensions of family functioning and this study will use the questions from three subscales (affective response, communication and general functioning). Response categories are as follows: strongly agree, agree, disagree, and strongly disagree. Scores range from 1 to 4 with 1 reflecting healthy functioning and 4 reflecting unhealthy functioning. (24 items; alpha = .92)
Baseline, 1 week, 3 months, 6 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Pennsylvania

Investigadores

  • Investigador principal: Dalmacio D Flores, University of Pennsylvania

Publicações e links úteis

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Publicações Gerais

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 (Real)

1 de janeiro de 2026

Conclusão Primária (Estimado)

30 de dezembro de 2027

Conclusão do estudo (Estimado)

30 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

13 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de setembro de 2026

Primeira postagem (Real)

17 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 24-0991 (856181)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Only statistical information for primary and secondary outcomes will be shared. Individual participant data will not be shared.

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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