Clinical Trials

MainTitle

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

This study has been enrolling by invitation
Sponsor
George Washington University

Collaborator
National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
David Huebner, George Washington University

ClinicalTrials.gov Identifier
NCT04018573

First received: June 18, 2019
Last updated: July 11, 2019
Last Verified: July 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections

Behavioral : PATHS Sexual Communication Toolkit
Behavioral : Parent Support Film

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developing an HIV Prevention Intervention for Young MSM Through Improved Parent-child Communication

Further study details as provided by David Huebner, George Washington University:

Primary Outcome Measures

  • Change in Sexual Health Communication Checklist score -- Parents [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ Time Frame: Parents are queried at baseline, 8-week followup, and 12-week followup. Sons are queried at baseline and 12-week followup. ]
    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 [ Time Frame: For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up ]
    11-item scale assessing participants' confidence in their ability to correctly use and acquire condoms. Assessed in parents and sons.
Other Outcome Measures:
  • Change in HIV knowledge [ Time Frame: For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up. ]
    17-item true/false scale assessing factual knowledge about HIV
  • Change in condom knowledge [ Time Frame: For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up ]
    Participants are presented with 13 statements, and are asked to identify which 6 describe accurate steps in correct condom use.
  • Change in self-efficacy for communicating with a child about condoms [ Time Frame: Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup. ]
    6-items assessing parents' confidence in their ability to talk with their sons about condom use
  • Change in outcome expectancy for condom communication [ Time Frame: Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup. ]
    12-item scale assessing the degree to which parents believe positive or negative things would happen if they talked to their son about condoms.

Estimated Enrollment: 60
Study Start Date: June 14, 2019
Estimated Study Completion Date: June 1, 2020
Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Parent Support Film
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.
Behavioral: Parent Support Film

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.

Other Name: Lead with Love
Experimental: Parent Support Film + PATHS Sexual Communication Toolkit
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.
Behavioral: PATHS Sexual Communication Toolkit

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.

Behavioral: Parent Support Film

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.

Other Name: Lead with Love
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04018573

Locations

United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052

Sponsors and Collaborators

George Washington University
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: David M Huebner, PhD, MPH George Washington University
More Information

More Information


Responsible Party: David Huebner, Associate Professor, George Washington University  
ClinicalTrials.gov Identifier: NCT04018573   History of Changes  
Other Study ID Numbers: MH112445  
  R34MH112445  
Study First Received: June 18, 2019  
Last Updated: July 11, 2019  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.