NCT07672067

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
476

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
May 2026Aug 2029

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2029

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

2.7 years

First QC Date

June 22, 2026

Last Update Submit

July 13, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    Baseline, 3 months, 6 months, 12 months

  • 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)

    Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (4)

  • Adolescent and Parent Mental Health (Depression)

    Baseline, 3 months, 6 months, 12 months

  • Adolescent and Parent Mental Health (Anxiety)

    Baseline, 3 months, 6 months, 12 months

  • Parent-Adolescent Health Behavior (Wellness Appointment)

    Baseline, 3 months, 6 months, 12 months

  • Family Functioning

    Baseline, 3 months, 6 months, 12 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: Parents ASSIST

Control Arm

ACTIVE COMPARATOR

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.

Behavioral: Parents ASSIST

Interventions

Parents ASSISTBEHAVIORAL

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.

Also known as: Parents Advancing Supportive and Sexuality Inclusive Sex Talks
Control ArmIntervention Arm

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35010638BACKGROUND
  • 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.

    PMID: 32003286BACKGROUND

Study Officials

  • Dalmacio D Flores, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalmacio D Flores, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

August 30, 2029

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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

Locations