Clinical trial NCT06564025: Pilot of an Online Sexual Health Program
Official title: Pilot of a Father-based Intervention to Support Adolescents' Reproductive Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Program, Communication
Keywords: sex education
father-teen program
family intervention
Lead sponsor: Wellesley College
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria for fathers:

* 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.

Exclusion criteria for fathers:

* 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
* cannot participate in intervention in English Inclusion criteria for adolescents
* 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
* have a reading level of 6th grade or above Exclusion criteria for adolescents
* 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

Primary outcomes:
measure: Sexual knowledge
timeFrame: immediately before and immediately after the intervention
measure: Sexual Communication Self-Efficacy Scale
timeFrame: immediately before and immediately after the intervention
measure: Self-Efficacy in Relationships
timeFrame: immediately before and immediately after the intervention
measure: Self-Efficacy for Consent
timeFrame: immediately before and immediately after the intervention
measure: Self-Efficacy for Communication with Teens about Sex
timeFrame: immediately before and immediately after the intervention
measure: Comfort Talking with Family about Sex
timeFrame: immediately before and immediately after the intervention
measure: Open Communication Scale
timeFrame: immediately before and immediately after the intervention
measure: Communication about Sex and Protection
timeFrame: immediately before and immediately after the intervention
measure: Communication with family about sex & relationships
timeFrame: immediately before and immediately after the intervention
measure: Frequency of Talk with Family about Sex and Relationships
timeFrame: immediately before and immediately after the intervention
measure: Feasibility of Intervention Measure
timeFrame: immediately after the intervention
measure: Feasibility: Participants' experience of the program's ease
timeFrame: immediately after the intervention
measure: Acceptability of Intervention Measure: whether participants approve of the program
timeFrame: immediately after the intervention
measure: Intervention Acceptability and Tolerability: Participants' experience of the program's importance
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Wellesley
country: United States
facility: Wellesley College
state: Massachusetts
Study officials:
References: