- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07672067
Intervention to Improve Parent Communication About Sexuality
July 13, 2026 updated by: University of Pennsylvania
The study is centered on helping parents answer and meet the sexuality-specific questions and needs of gay or bisexual males.
This study seeks to test the efficacy of Parents ASSIST as a parent-child sexuality communication intervention that educates and trains parents to be purveyors of inclusive health information as gay or bisexual sons come of age at home.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Parental acceptance after youth come out as gay 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 Parents ASSIST (Advancing Supportive and Sexuality Inclusive Sex Talks), a sexuality communication intervention for parents, after youth disclose gay or bisexual identities.
We will conduct a randomized controlled trial with parent and gay or bisexual youth dyads (N=476) to establish the efficacy of Parents ASSIST 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 Parents ASSIST 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 Parents ASSIST results in decreases in mental health symptomology (e.g.
depressive and anxiety symptoms) among parents and gay or bisexual 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 gay or bisexual child) mediate the intervention effects on adolescent and parent mental health, parent-adolescent health behavior and family functioning over time.
Study Type
Interventional
Enrollment (Estimated)
476
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dalmacio D Flores, PhD
- Phone Number: 4043944593
- Email: dalmacio@nursing.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Dalmacio D Flores, PhD
- Phone Number: 404-394-4593
- Email: dalmacio@nursing.upenn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Youth participants are:
- identify as a cisgender sexual minority male (e.g., gay or bisexual)
- 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 gay or bisexual adolescent
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
Parents randomized to receive the intervention (n=238) will be assigned to a 5-session online intervention that comprise 8-12 parents per cohort.
They will register their profiles via our secure, password-protected Parents ASSIST website.
Parents in the intervention arm will complete one session per week where they watch two videos focused on sexual health and family communication.
They will also be asked to complete homework tasks with their GBQ child.
GBQ adolescents will not be intervened upon directly; rather, we will instruct parents to engage their sons based on the information and skills learned weekly through the intervention.
|
Parents ASSIST 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 the i 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 specific GBQ issues 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.
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 GBQ youth.
Other Names:
|
|
Active Comparator: Control Arm
Control group participants (n=238 parents) will be assigned to the health promotion arm and similarly asked to register into our secure Parents ASSIST study site but will be assigned to the control group educational resources: alcohol use, bullying, sleep hygiene, tobacco use, and body image issues.
Individual participants will access via the website the videos on these non-sexual health focused conditions.
|
Parents ASSIST 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 the i 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 specific GBQ issues 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.
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 GBQ youth.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent-Adolescent Communication Quality
Time Frame: Baseline, 3 months, 6 months, 12 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, 3 months, 6 months, 12 months
|
|
Parent-Adolescent Communication Quantity
Time Frame: Baseline, 3 months, 6 months, 12 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, 3 months, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adolescent and Parent Mental Health (Depression)
Time Frame: Baseline, 3 months, 6 months, 12 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, 3 months, 6 months, 12 months
|
|
Adolescent and Parent Mental Health (Anxiety)
Time Frame: Baseline, 3 months, 6 months, 12 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, 3 months, 6 months, 12 months
|
|
Parent-Adolescent Health Behavior (Wellness Appointment)
Time Frame: Baseline, 3 months, 6 months, 12 months
|
We will measure successful setting up by both parent and GBQ 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/GBQ child looked up LGBTQ-friendly health providers in your area?
(Yes/No); (2) Since the last survey, have you and your parent/GBQ child made an appointment for a wellness appointment?
(Yes/No); and (3) Since the last survey, have you and your parent/GBQ child seek out a healthcare provider to be screened for a sexually-transmitted infection?
(Yes/No).
|
Baseline, 3 months, 6 months, 12 months
|
|
Family Functioning
Time Frame: Baseline, 3 months, 6 months, 12 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, 3 months, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dalmacio D Flores, PhD, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Flores 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2026
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
August 30, 2029
Study Registration Dates
First Submitted
June 22, 2026
First Submitted That Met QC Criteria
June 22, 2026
First Posted (Actual)
June 26, 2026
Study Record Updates
Last Update Posted (Actual)
July 15, 2026
Last Update Submitted That Met QC Criteria
July 13, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 856192 (24-1002)
- R01HD111516 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Only statistical information for primary and secondary outcomes will be shared.
Individual participant data will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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