NCT07825571 · University of Pennsylvania
The Gender Inclusive Sexuality Talks Program
(GIST)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Parent-Adolescent Communication Quantity
Time frame: 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
Time frame: 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2026 · Source of record for eligibility and locations