Recruiting

GIST Program

Sponsor:

University of Pennsylvania

Code:

NCT07825571

Conditions

HIV/STI Incidence

Communication About Health Information

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

The Gender Inclusive Sexuality Talks Program

GIST Control

Study Details

Brief summary:

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.

Conditions

HIV/STI Incidence

Communication About Health Information

Study ID

NCT07825571

Start date

Jan 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: GIST Intervention Arm

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

active comparator: 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.

Interventions

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.

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.

Primary outcome measure

  • Parent-Adolescent Communication Quantity [ Time Frame: Baseline, 1 week, 3 months, 6 months ]
  • Parent-Adolescent Communication Quality [ Time Frame: Baseline, 1 week, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Dalmacio Flores, PhD, RN

215-573-8253dalmacio@nursing.upenn.edu

Locations

Penn Nursing

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Dalmacio Flores, PhD, RN

215-573-8253dalmacio@nursing.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-09-17.