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The Gender Inclusive Sexuality Talks Program (GIST)

2026年9月13日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

300

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • 募集
        • Penn Nursing
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：GIST Intervention Arm
Parents randomized to this arm will receive five, online based group sessions.
行動：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.
アクティブコンパレータ：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.
行動：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.

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
Parent-Adolescent Communication Quantity
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Adolescent and Parent Mental Health (Depression)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Pennsylvania

捜査官

  • 主任研究者：Dalmacio D Flores、University of Pennsylvania

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月1日

一次修了 (推定)

2027年12月30日

研究の完了 (推定)

2027年12月30日

試験登録日

最初に提出

2026年9月13日

QC基準を満たした最初の提出物

2026年9月13日

最初の投稿 (実際)

2026年9月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月17日

QC基準を満たした最後の更新が送信されました

2026年9月13日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 24-0991 (856181)

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?

いいえ

IPD プランの説明

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

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