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

HIV Infections Clinical Trial

— PATHS  

Official title:

Developing an HIV Prevention Intervention for Young MSM Through Improved Parent-child Communication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018573
• Other study ID #: MH112445
• Secondary ID: R34MH112445
• Status: Completed
• Phase: N/A
• Start date: June 14, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	George Washington University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in HIV knowledge	17-item true/false scale assessing factual knowledge about HIV	For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up.
Other	Change in condom knowledge	Participants are presented with 13 statements, and are asked to identify which 6 describe accurate steps in correct condom use.	For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up
Other	Change in self-efficacy for communicating with a child about condoms	6-items assessing parents' confidence in their ability to talk with their sons about condom use	Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup.
Other	Change in outcome expectancy for condom communication	12-item scale assessing the degree to which parents believe positive or negative things would happen if they talked to their son about condoms.	Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup.
Primary	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.	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.
Primary	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.	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	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).	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.
Secondary	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.	Parents are queried at baseline, 8-week followup, and 12-week followup. Sons are queried at baseline and 12-week followup.
Secondary	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.	For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up