- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018573
Testing an Online Intervention to Improve Parents' Communication With Gay and Bisexual Sons About Sex and HIV (PATHS)
June 2, 2023 updated by: David Huebner, George Washington University
Developing an HIV Prevention Intervention for Young MSM Through Improved Parent-child Communication
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20052
- George Washington University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
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.
|
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 Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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
Time Frame: Parents are queried at baseline, 8-week followup, and 12-week followup. Sons are queried at baseline and 12-week followup.
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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.
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Parents are queried at baseline, 8-week followup, and 12-week followup. Sons are queried at baseline and 12-week followup.
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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
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11-item scale assessing participants' confidence in their ability to correctly use and acquire condoms.
Assessed in parents and sons.
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For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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For parents: change from baseline to immediate post-intervention. For sons: change from baseline to 12-week follow-up.
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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
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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
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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
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Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup.
|
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.
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Change from baseline to (a) immediate post-intervention, (b) 8 week followup, and (c) 12 week followup.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David M Huebner, PhD, MPH, George Washington University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2019
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
June 18, 2019
First Submitted That Met QC Criteria
July 11, 2019
First Posted (Actual)
July 12, 2019
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
June 2, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- MH112445
- R34MH112445 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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