Pilot of an Online Sexual Health Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-30

Study Completion Date

2026-03-01

Brief Summary

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This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. This study involves conducting a pilot intervention with 50 pairs of fathers and their high-school aged teens. Feasibility and acceptability will be assessed through program data such as participants' pilot enrollment, lesson feedback, and program retention, survey data and member checks through debrief interviews (5 father, 5 teens). Preliminary assessment of directionality of change in participants' health-related knowledge, self-efficacy, and outcome expectations over the course of the pilot intervention (pre- and post-intervention surveys) to determine whether a full-scale R01 is warranted.

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Detailed Description

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This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. This study involves conducting a pilot intervention with 50 pairs of fathers and their high-school aged teens. Feasibility and acceptability will be assessed through program data such as participants' pilot enrollment, lesson feedback, and program retention, survey data from Acceptability of Intervention Measure and Feasibility of Intervention Measure, and member checks through debrief interviews (5 father, 5 teens). Preliminary assessment of directionality of change in participants' health-related knowledge, self-efficacy, and outcome expectations over the course of the pilot intervention (pre- and post-intervention surveys) to determine whether a full-scale R01 is warranted.

The investigators will recruit a diverse sample of father-adolescent pairs (N=50 pairs) through partnership with three community partner organizations. Fathers will be asked questions online to determine project eligibility and demographics (screener) and given an online consent form. If a father agrees to teens' participation, the teen will be sent an assent form for their own participation and a brief screener survey. If teens are 18 or older, the investigators will request their contact information from participating fathers and ask teens to provide their own consent. Only father/teen pairs who complete the screeners and consent/assent forms, meet eligibility criteria, and both agree to participate can join the study.

All pilot participants will be given a pre-and post-intervention survey to assess any change in proximal outcomes. Participants will be asked to participate in 3 online modules over 6 weeks which include 3 online lessons (father and teens complete separately) and father/teen activities (fathers and teens complete together) and 3 father support group (father only). Each module will last one week and will include an online lesson and father-teen activity (fathers and teens) and online father support group session (fathers only). Lessons and support group sessions will include feedback questions (acceptability). Tracking of enrollment, retention, and duration of lesson participation will provide feasibility assessment. To obtain in-depth feedback on participants' responses to the intervention (acceptability), and to conduct member checks on pilot lesson feedback, the investigators will conduct debrief interviews with a purposive sample of pilot participants (5 fathers, 5 teens) with variation in: teen gender and level of intervention engagement.

The 3 module, 3-week intervention will be delivered on Qualtrics and Zoom, accessible via computer or tablet. Online lessons will be self-paced within each week and will each include a father-teen activity, with text and e-mail reminders at the start and end of the week. Father support groups will occur online at a scheduled time planned based on fathers' schedules. Given the limited scope of the project, prototype technology will be relatively simple, with more advanced technology planned for a future R01.

Conditions

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Program, Communication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

To assess program feasibility, acceptability, and preliminary efficacy, the investigators will pilot the intervention with a purposive sample of 50 father-teen pairs. All participants will receive the intervention. An online screener, pre- and post-intervention surveys, and brief module feedback will assess feasibility and acceptability. Pre- and post-intervention surveys will provide initial data on directionality for correlates of teens' sexual risk behaviors to determine whether a full-scale R01 is warranted. Debrief interviews with a purposive sample of pilot participants (5 fathers, 5 teens) will obtain in-depth intervention feedback and conduct member checks on module feedback. The investigators will revise the intervention prototype based on feasibility, acceptability, and preliminary efficacy data, then write up and distribute findings for dissemination.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pilot group for program

To assess program feasibility, acceptability, and preliminary efficacy, we will pilot the intervention with a purposive sample of 50 father-teen pairs (100 participants total). All participants will receive the program.

Group Type EXPERIMENTAL

Pilot program study

Intervention Type BEHAVIORAL

To assess program feasibility, acceptability, and preliminary efficacy, we will pilot the intervention with a purposive sample of 50 father-teen pairs (100 participants total). All participants will receive the program.

Interventions

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Pilot program study

To assess program feasibility, acceptability, and preliminary efficacy, we will pilot the intervention with a purposive sample of 50 father-teen pairs (100 participants total). All participants will receive the program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* adult (18 or older)
* father (biological, step, adopted, or foster) of a participating teen and
* report regular contact with the teen
* healthy enough to participate in online surveys, an online intervention, interactive activities (either online, over the phone or in-person) with the adolescent, and an online support group
* speak English
* have a reading level of 6th grade or above.

* high-school aged child (biological, step, adopted, or foster) of a participating father
* report regular contact with their father
* healthy enough to participate in online surveys and interactive activities (either online, over the phone or in-person) with the father

Exclusion Criteria

* not a father (biological, step, adopted, or foster) of a participating high-school aged teen
* under the age of 18
* not in regular contact with their teen
* not in high school
* not in regular contact with the father
* not child (biological, step, adopted, or foster) of participating father
* cannot participate in intervention in English

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes