A Randomized Controlled Trial to Evaluate a Digital Sexual Assertiveness Intervention for Adolescent Sexual Minority Males
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Indiana University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Condom negotiation intentions
Study Overview
Brief Summary
The purpose of this study is to test the effectiveness, likability, and implementation potential of PACT, an adapted digital program to teach non-heterosexual adolescent boys about sexual consent and condom negotiation in a randomized controlled trial over 9 months.
Detailed Description
Because the PACT (Promoting Affirmative Consent among Teens) digital health intervention showed evidence of effectiveness at improving sexual consent cognitions in its first trial, and was found generally likable among adolescents, the research team has adapted the program to serve as sexual assertiveness (consent and condom negotiation) training. This adapted version is tailored to the specific needs of adolescent sexual minority males (ASMM), a population that has been historically underserved by traditional sex education while also experiencing disproportionately high rates of both sexual violence victimization and condom non-use. The evaluation of the adapted PACT program (now titled Promoting Assertive Communication among Teens) will take place in an RCT with a Type 1 effectiveness-implementation hybrid design. Surveys will be administered at pre-intervention, post-intervention, 3-month follow-up, and 9-month follow-up. The investigators will assess acceptability, implementation factors, and main and secondary outcomes related to consent and condom negotiation/use.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 14 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •14-17 years old
- •lives in the U.S.
- •identifies as a queer teen guy or sexual minority male
Exclusion Criteria
- •younger than 14
- •older than 17
- •does not live in U.S.
- •does not identify as a queer teen guy or sexual minority male
Arms & Interventions
Promoting Assertive Communication among Teens (PACT)
A 30-minute digital program designed to teach adolescent sexual minority males information and skills regarding two dimensions of sexual assertiveness: consent and condom negotiation.
Intervention: Promoting Assertive Communication among Teens (PACT) (Other)
Healthy Minds
An attention-matched digital program focused on growth mindsets and mental health, designed for a general population of adolescents.
Intervention: Healthy Minds (Other)
Outcomes
Primary Outcomes
Condom negotiation intentions
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
Participants' likelihood of using a condom during sexual intercourse with a partner
Affirmative consent intentions
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
Participants' likelihood of 1) ensuring consent is obtained from a partner prior to sexual intercourse and 2) communicating their consent affirmatively to a partner prior to intercourse
Condom negotiation self-efficacy
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
Participants' confidence in their ability to assert their desire to use a condom with a partner (5-point likert, strongly disagree to strongly agree, higher scores = higher self-efficacy)
Affirmative consent self-efficacy
Time Frame: Baseline, immediately post-intervention, 3 months, 9 months
Participants' confidence in their ability to communicate sexual consent with a partner (4-point likert, "not at all confident" to "very confident", higher scores = higher self-efficacy)
Secondary Outcomes
- Condom use(Baseline, 3 months, 9 months)
- Condom negotiation(Baseline, 3 months, 9 months)
- Affirmative consent communication(Baseline, 3 months, 9 months)
- Condom attitudes(Baseline, immediately post-intervention, 3 months, 9 months)
- Affirmative consent attitudes(Baseline, immediately post-intervention, 3 months, 9 months)
- Condom norms(Baseline, immediately post-intervention, 3 months, 9 months)
- Affirmative consent norms(Baseline, immediately post-intervention, 3 months, 9 months)
- Acceptability(Immediately post-intervention)
Investigators
Eric R. Walsh-Buhi
Professor Applied Health Sciences
Indiana University