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

NCT04018573 | Completed

• 2 other identifiers: MH112445R34MH112445
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (3)

• Change in parent intentions for sexual health communication

  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.

• Change in Parent-Adolescent Sexual Health Communication Assessment

  Parents are queried at baseline, 8-week followup, and 12-week followup. Sons are queried at baseline and 12-week followup.

• Change in condom-use self efficacy

  For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up

Other Outcomes (4)

• Change in HIV knowledge

  For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up.

• Change in condom knowledge

  For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up

• Change in self-efficacy for communicating with a child about condoms

  Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup.

Study Arms (2)

Parent Support Film

ACTIVE COMPARATOR

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

Parent Support Film + PATHS Sexual Communication Toolkit

EXPERIMENTAL

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; Behavioral: Parent Support Film

Interventions

PATHS Sexual Communication Toolkit BEHAVIORAL

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 + PATHS Sexual Communication Toolkit

Parent Support Film BEHAVIORAL

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.

Also known as: Lead with Love

Parent Support Film; Parent Support Film + PATHS Sexual Communication Toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Child with known HIV infection

Sponsors & Collaborators

• George Washington University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Related Publications (1)

• 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.

  PMID: 36352294 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Lead

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• David M Huebner, PhD, MPH

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 12, 2019
• Study Start: June 14, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

US (1)