Evaluating a Digital Sexual Assertiveness Intervention for ASMM

NCT ID: NCT06878755

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-07-31

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.

Conditions

Condomless Sex; Sexual Assault

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Promoting Assertive Communication among Teens (PACT)

Intervention Type: OTHER

See Arm Description

Healthy Minds

An attention-matched digital program focused on growth mindsets and mental health, designed for a general population of adolescents.

Group Type: ACTIVE_COMPARATOR

Healthy Minds

Intervention Type: OTHER

See Arm Description

Interventions

Promoting Assertive Communication among Teens (PACT)

See Arm Description

Intervention Type: OTHER

Healthy Minds

See Arm Description

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Eric R. Walsh-Buhi

Professor Applied Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University

Bloomington, Indiana, United States

Countries

United States

Central Contacts

Hannah Javidi, PhD

Role: CONTACT

hsjavidi@iu.edu

7042807859

Eric Walsh-Buhi, PhD, MPH

Role: CONTACT

erwals@iu.edu

Facility Contacts

Hannah Javidi, PhD

Role: primary

hsjavidi@iu.edu

7042807859

References

Javidi H, Widman L, Maheux AJ, McCrimmon J, Evans-Paulson R, Becker W. PACT: Developing and Evaluating a Digital Sexual Consent Program for Youth. J Sex Res. 2024 Mar-Apr;61(3):466-480. doi: 10.1080/00224499.2023.2208560. Epub 2023 May 15.

Reference Type: BACKGROUND

PMID: 37186689 (View on PubMed)

Other Identifiers

20740

Identifier Type: -

Identifier Source: org_study_id