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Testing an Online Intervention to Improve Parents' Communication With Gay and Bisexual Sons About Sex and HIV (PATHS)

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PATHS Sexual Communication Toolkit
Parent Support Film
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parent or legal guardian of a child with all of the following characteristics:

    1. cisgender male
    2. age 14-22
    3. self-identify as gay or bisexual
    4. lives in the same house with parent at least 2 days per week.

      Exclusion Criteria:

  • Child with known HIV infection

Sites / Locations

  • George Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Parent Support Film

Parent Support Film + PATHS Sexual Communication Toolkit

Arm Description

Parents will watch Lead with Love, a 35-minute documentary style film designed to provide support, information, and behavioral guidance to parents with a lesbian, gay, or bisexual child. One month later, parents will look over material that reviews the major points of the film. All of this material is presented online via our webapp.

Parents in this arm will have the option of watching Lead with Love, and then will engage with our parent toolkit, designed to increase the frequency and quality of parent-child communication about HIV and condoms. One month later, parents will engage with booster content, customized to address their self-reported barriers to communicating with their sons. All of this material is presented online via our webapp.

Outcomes

Primary Outcome Measures

Change in Sexual Health Communication Checklist score -- Parents
This is a new measure developed for this pilot study. Thus, we will first examine the measure's reliability and validity. Assuming acceptable psychometric properties, this will be the primary outcome measure. The checklist queries parents and children whether they have engaged in four different activities specifically recommended by our intervention: providing information about HIV, providing information about correct condom usage, providing information about condom acquisition, and supporting HIV testing. For each of those four activities, families have multiple ways to do the activity (e.g., for providing information about correct condom use, parents can: send a video, explain the process, or demonstrate the process). Thus, the checklist queries 11 specific behaviors. Families are coded as having completed the activity if they have engaged in any one of the multiple behaviors congruent with the corresponding activity. Thus, scores on the measure range from 0-4.
Change in Sexual Health Communication Checklist score -- Child
This is a new measure developed for this pilot study. Thus, we will first examine the measure's reliability and validity. Assuming acceptable psychometric properties, this will be the primary outcome measure. The checklist queries parents and children whether they have engaged in four different activities specifically recommended by our intervention: providing information about HIV, providing information about correct condom usage, providing information about condom acquisition, and supporting HIV testing. For each of those four activities, families have multiple ways to do the activity (e.g., for providing information about correct condom use, parents can: send a video, explain the process, or demonstrate the process). Thus, the checklist queries 11 specific behaviors. Families are coded as having completed the activity if they have engaged in any one of the multiple behaviors congruent with the corresponding activity. Thus, scores on the measure range from 0-4.

Secondary Outcome Measures

Change in parent intentions for sexual health communication
This is a new measure developed for this pilot study. It assesses parents' intentions in the "next several weeks" to engage in 11 specific sexual health activities with their sons (e.g., demonstrating condom use, taking son to get tested for HIV).
Change in Parent-Adolescent Sexual Health Communication Assessment
This measure contains subscales assessing: (a) sexual health communication frequency, (b) sexual health communication quality, and (c) negative emotionality during sexual health communication. There are both parent and child reports.
Change in condom-use self efficacy
11-item scale assessing participants' confidence in their ability to correctly use and acquire condoms. Assessed in parents and sons.

Full Information

First Posted
June 18, 2019
Last Updated
June 2, 2023
Sponsor
George Washington University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04018573
Brief Title
Testing an Online Intervention to Improve Parents' Communication With Gay and Bisexual Sons About Sex and HIV
Acronym
PATHS
Official Title
Developing an HIV Prevention Intervention for Young MSM Through Improved Parent-child Communication
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Young men who have sex with men (MSM) are at high risk for HIV infection in the United States, representing 80% of all infections among youth ages 14-24, and 92% of infections among boys ages 14-19. Despite these risks, the field has not even one HIV prevention intervention shown to be effective in decreasing sexual risks or increasing HIV testing among adolescent MSM (AMSM). Historically, reaching AMSM for HIV prevention has been challenging, given their relative geographic isolation and lack of access to traditional gay congregating spaces (e.g., bars and many gay-related social networking websites). However, the investigators have developed a novel online platform for delivering interventions to parents of LGB youth that currently sees thousands of visitors each year. HIV prevention advocates have identified parents of AMSM as an untapped resource for reducing HIV risk in this population. Parent-child communication about sex has well-demonstrated associations with adolescent risk behaviors, and interventions with parents of heterosexual youth have been shown to be effective in increasing parent-adolescent communication, and thereby, reducing adolescent health risks. Thus, the aim of the proposed study is to pilot test the efficacy of an online intervention to increase and improve parent communication with AMSM about sexuality and HIV, with the ultimate goal of decreasing adolescent sexual risk and increasing HIV testing. This will be achieved by randomizing parents who come to seek resources on the investigators' existing website to receive either (a) a film designed to support parents of LGB youth, or (b) that film + the online communication intervention materials, and then gathering longitudinal, online data from parents in both study arms and their AMSM sons over a 2-4 month period. It is hypothesized that parents in the intervention group will increase their communication with their sons about HIV and condoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Support Film
Arm Type
Active Comparator
Arm Description
Parents will watch Lead with Love, a 35-minute documentary style film designed to provide support, information, and behavioral guidance to parents with a lesbian, gay, or bisexual child. One month later, parents will look over material that reviews the major points of the film. All of this material is presented online via our webapp.
Arm Title
Parent Support Film + PATHS Sexual Communication Toolkit
Arm Type
Experimental
Arm Description
Parents in this arm will have the option of watching Lead with Love, and then will engage with our parent toolkit, designed to increase the frequency and quality of parent-child communication about HIV and condoms. One month later, parents will engage with booster content, customized to address their self-reported barriers to communicating with their sons. All of this material is presented online via our webapp.
Intervention Type
Behavioral
Intervention Name(s)
PATHS Sexual Communication Toolkit
Intervention Description
The PATHS Sexual Communication Toolkit is a self-guided, online intervention. The toolkit is comprised of 6 modules, covering a range of topics relevant to increasing parents' motivation, self-efficacy, and intention for communicating about sex. Material is presented in a variety of modalities (e.g., text, videos of experts, videos of other parents describing their experiences). Parents set personalized goals for themselves regarding activities and conversations they want to have with their sons, selecting from a menu of options provided by the intervention. A 1-month booster module queries parents about whether they have achieved their goals, and provides customized content to support the behaviors parents have yet to enact.
Intervention Type
Behavioral
Intervention Name(s)
Parent Support Film
Other Intervention Name(s)
Lead with Love
Intervention Description
Lead with Love is a 35-minute "education entertainment" film created to provide support, information, and behavioral guidance to parents of lesbian, gay, or bisexual (LGB) children. Drawing from stage-based models of behavior change, and social cognitive theory, it aims to help parents progress through the process of coming to accept their child's sexual orientation, recognizing the importance of their behaviors and reactions to their child's health, and accepting their child's sexual orientation, and engaging in behaviors that are more supportive and less rejecting. This is achieved by telling the true stories of four families and how they responded to the news that their child was LGB, and by having experts (psychologists, teachers, clergy) provide information and guidance.
Primary Outcome Measure Information:
Title
Change in Sexual Health Communication Checklist score -- Parents
Description
This is a new measure developed for this pilot study. Thus, we will first examine the measure's reliability and validity. Assuming acceptable psychometric properties, this will be the primary outcome measure. The checklist queries parents and children whether they have engaged in four different activities specifically recommended by our intervention: providing information about HIV, providing information about correct condom usage, providing information about condom acquisition, and supporting HIV testing. For each of those four activities, families have multiple ways to do the activity (e.g., for providing information about correct condom use, parents can: send a video, explain the process, or demonstrate the process). Thus, the checklist queries 11 specific behaviors. Families are coded as having completed the activity if they have engaged in any one of the multiple behaviors congruent with the corresponding activity. Thus, scores on the measure range from 0-4.
Time Frame
Parents are queried about whether they engaged in these behaviors at three time points: baseline, 4-6 week follow-up, and 8-12 week follow-up. We will assess change from baseline to each of the two followup points.
Title
Change in Sexual Health Communication Checklist score -- Child
Description
This is a new measure developed for this pilot study. Thus, we will first examine the measure's reliability and validity. Assuming acceptable psychometric properties, this will be the primary outcome measure. The checklist queries parents and children whether they have engaged in four different activities specifically recommended by our intervention: providing information about HIV, providing information about correct condom usage, providing information about condom acquisition, and supporting HIV testing. For each of those four activities, families have multiple ways to do the activity (e.g., for providing information about correct condom use, parents can: send a video, explain the process, or demonstrate the process). Thus, the checklist queries 11 specific behaviors. Families are coded as having completed the activity if they have engaged in any one of the multiple behaviors congruent with the corresponding activity. Thus, scores on the measure range from 0-4.
Time Frame
Sons are queried about whether their parents engaged in these behaviors at baseline and at 12 week followup. We will assess change from baseline to followup.
Secondary Outcome Measure Information:
Title
Change in parent intentions for sexual health communication
Description
This is a new measure developed for this pilot study. It assesses parents' intentions in the "next several weeks" to engage in 11 specific sexual health activities with their sons (e.g., demonstrating condom use, taking son to get tested for HIV).
Time Frame
Parents are given this measure at baseline, immediately post-intervention, and at 4-6 week follow-up after engaging with booster material. We will assess change from baseline to post intervention and from baseline to 4-6 week followup.
Title
Change in Parent-Adolescent Sexual Health Communication Assessment
Description
This measure contains subscales assessing: (a) sexual health communication frequency, (b) sexual health communication quality, and (c) negative emotionality during sexual health communication. There are both parent and child reports.
Time Frame
Parents are queried at baseline, 8-week followup, and 12-week followup. Sons are queried at baseline and 12-week followup.
Title
Change in condom-use self efficacy
Description
11-item scale assessing participants' confidence in their ability to correctly use and acquire condoms. Assessed in parents and sons.
Time Frame
For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up
Other Pre-specified Outcome Measures:
Title
Change in HIV knowledge
Description
17-item true/false scale assessing factual knowledge about HIV
Time Frame
For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up.
Title
Change in condom knowledge
Description
Participants are presented with 13 statements, and are asked to identify which 6 describe accurate steps in correct condom use.
Time Frame
For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up
Title
Change in self-efficacy for communicating with a child about condoms
Description
6-items assessing parents' confidence in their ability to talk with their sons about condom use
Time Frame
Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup.
Title
Change in outcome expectancy for condom communication
Description
12-item scale assessing the degree to which parents believe positive or negative things would happen if they talked to their son about condoms.
Time Frame
Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parent or legal guardian of a child with all of the following characteristics: cisgender male age 14-22 self-identify as gay or bisexual lives in the same house with parent at least 2 days per week. Exclusion Criteria: Child with known HIV infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Huebner, PhD, MPH
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36352294
Citation
Huebner DM, Barnett AP, Baucom BRW, Guilamo-Ramos V. Effects of a Parent-Focused HIV Prevention Intervention for Young Men Who have Sex with Men: A Pilot Randomized Clinical Trial. AIDS Behav. 2023 May;27(5):1502-1513. doi: 10.1007/s10461-022-03885-1. Epub 2022 Nov 10.
Results Reference
derived

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Testing an Online Intervention to Improve Parents' Communication With Gay and Bisexual Sons About Sex and HIV

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