HIV/STI IncidenceGISTNCT07825571
The Gender Inclusive Sexuality Talks Program
A study testing The Gender Inclusive Sexuality Talks Program in people with HIV/STI Incidence and Communication About Health Information, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- HIV/STI Incidence, Communication About Health Information
- What is being tested?
- The Gender Inclusive Sexuality Talks Program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn Nursing
Philadelphia, Pennsylvania, 19104
Dalmacio Flores, PhD, RN, 215-573-8253, dalmacio@nursing.upenn.edu
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- The Gender Inclusive Sexuality Talks Program, GIST Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Gender Inclusive Sexuality Talks ProgramBehavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GIST Intervention Arm | Experimental | Parents randomized to this arm will receive five, online based group sessions. Receives: Behavioral: The Gender Inclusive Sexuality Talks Program |
| 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. Receives: Behavioral: GIST Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-Adolescent Communication Quantity
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)
Measured: Baseline, 1 week, 3 months, 6 months
Parent-Adolescent Communication Quality
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)
Measured: Baseline, 1 week, 3 months, 6 months
Secondary outcomes (4)
Adolescent and Parent Mental Health (Depression)
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)
Measured: Baseline, 1 week, 3 months, 6 months
Adolescent and Parent Mental Health (Anxiety)
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)
Measured: Baseline, 1 week, 3 months, 6 months
Parent-Adolescent Health Behavior (Wellness Appointment)
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).
Measured: Baseline, 1 week, 3 months, 6 months
Family Functioning
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)
Measured: Baseline, 1 week, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jan 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/STI IncidenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each parent will receive both study conditions: (1) the intervention workshop and (2) control videos, with sequencing order of the two arms randomized. Following completion of participation in a study arm, there will be a 4-week washout, which is sufficient to assess short-term retention while minimizing contamination across conditions.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalmacio Flores, University of Pennsylvania
- Investigators
- Dalmacio D Flores, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825571
- Sponsor's protocol ID
- 24-0991 (856181)
- Acronym
- GIST
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only statistical information for primary and secondary outcomes will be shared. Individual participant data will not be shared.
Publications
Flores DD, Rosario AA, Bond KT, Villarruel AM, Bauermeister JA. Parents ASSIST (Advancing Supportive and Sexuality-Inclusive Sex Talks): Iterative Development of a Sex Communication Video Series for Parents of Gay, Bisexual, and Queer Male Adolescents. J Fam Nurs. 2020 May;26(2):90-101. doi: 10.1177/1074840719897905. Epub 2020 Jan 31.
PubMed 32003286Flores DD, Hennessy K, Rosario A, Chung J, Wood S, Kershaw T, Villarruel A, Bauermeister J. Parents ASSIST: Acceptability and Feasibility of a Video-Based Educational Series for Sexuality-Inclusive Communication between Parents and Gay, Bisexual, and Queer Sons. Int J Environ Res Public Health. 2021 Dec 30;19(1):379. doi: 10.3390/ijerph19010379.
PubMed 35010638
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents ASSIST for All LGBTQ Youth (Hillman)
- ClinicalTrials.gov ID
- NCT07825571
- Acronym / sponsor ID
- GIST / 24-0991 (856181)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each parent will receive both study conditions: (1) the intervention workshop and (2) control videos, with sequencing order of the two arms randomized. Following completion of participation in a study arm, there will be a 4-week washout, which is sufficient to assess short-term retention while minimizing contamination across conditions.
| Arm | Type | Receives |
|---|---|---|
| GIST Intervention Arm | Experimental | Behavioral: The Gender Inclusive Sexuality Talks ProgramParents randomized to this arm will receive five, online based group sessions. |
| Control Arm | Active comparator | Behavioral: GIST ControlParents 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. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (4 listed)
- non-transgender or gender diverse or lesbian or bisexual female youth
- parents whose child does not meet eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Gender Inclusive Sexuality Talks ProgramThe 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. | Behavioural | GIST Intervention Arm |
| GIST ControlThe 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. | Behavioural | Control Arm |
Primary outcome
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)
4 secondary outcomes
Adolescent and Parent Mental Health (Depression)
Time frame: Baseline, 1 week, 3 months, 6 months
Adolescent and Parent Mental Health (Anxiety)
Time frame: Baseline, 1 week, 3 months, 6 months
Parent-Adolescent Health Behavior (Wellness Appointment)
Time frame: Baseline, 1 week, 3 months, 6 months
Family Functioning
Time frame: Baseline, 1 week, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 32003286Flores DD, Rosario AA, Bond KT, Villarruel AM, Bauermeister JA. Parents ASSIST (Advancing Supportive and Sexuality-Inclusive Sex Talks): Iterative Development of a Sex Communication Video Series for Parents of Gay, Bisexual, and Queer Male Adolescents. J Fam Nurs. 2020 May;26(2):90-101. doi: 10.1177/1074840719897905. Epub 2020 Jan 31.
- Background: PubMed 35010638Flores DD, Hennessy K, Rosario A, Chung J, Wood S, Kershaw T, Villarruel A, Bauermeister J. Parents ASSIST: Acceptability and Feasibility of a Video-Based Educational Series for Sexuality-Inclusive Communication between Parents and Gay, Bisexual, and Queer Sons. Int J Environ Res Public Health. 2021 Dec 30;19(1):379. doi: 10.3390/ijerph19010379.
- Individual participant dataSharing planned: No. Only statistical information for primary and secondary outcomes will be shared. Individual participant data will not be shared.
Related trials for HIV/STI Incidence
Recruiting
Intervention to Improve Parent Communication About Sexuality
HIV/STI Incidence, Communication About Health Information
Not yet recruitingObservational study
Disease Evolution and Risk Factors of AIDS-related Prevalent Cancers
HIV (Human Immunodeficiency Virus), AIDS
Recruiting
Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys
HIV Infections
Active, not recruiting
Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy
Hiv
Recruiting
Effectiveness of Relationship Education for Reducing HIV Incidence Among Men Who Have Sex With Men
Hiv, Chlamydia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dalmacio D Flores principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Gender Inclusive Sexuality Talks Program in people with HIV/STI Incidence and Communication About Health Information, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalmacio Flores, PhD, RN (215-573-8253, dalmacio@nursing.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-Adolescent Communication Quantity (time frame: Baseline, 1 week, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07825571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.