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临床试验/NCT07825571
NCT07825571招募中不适用

Parents ASSIST for All LGBTQ Youth (Hillman)

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Parent-Adolescent Communication Quantity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

GIST Intervention Arm

Experimental

Parents randomized to this arm will receive five, online based group sessions.

干预措施: The Gender Inclusive Sexuality Talks Program (Behavioral)

Control Arm

Active Comparator

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.

干预措施: GIST Control (Behavioral)

结局指标

主要结局

Parent-Adolescent Communication Quantity

时间窗: 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)

Parent-Adolescent Communication Quality

时间窗: 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)

次要结局

  • Adolescent and Parent Mental Health (Depression)(Baseline, 1 week, 3 months, 6 months)
  • Adolescent and Parent Mental Health (Anxiety)(Baseline, 1 week, 3 months, 6 months)
  • Parent-Adolescent Health Behavior (Wellness Appointment)(Baseline, 1 week, 3 months, 6 months)
  • Family Functioning(Baseline, 1 week, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dalmacio Flores

Associate Professor

University of Pennsylvania

研究点 (1)

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