Pilot of an Online Sexual Health Program
NCT Number: NCT06564025
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Program, Communication
Interventions: BEHAVIORAL: Pilot program study
Sponsor: Wellesley College
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2025-03

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.

Primary Outcome Measures: Sexual knowledge, Participants' knowledge about contraception, condom use, and sexually transmitted infections for fathers and teens (3 sub-scales, self-report, true/false with higher score indicating greater knowledge)., immediately before and immediately after the intervention|Sexual Communication Self-Efficacy Scale, Teen participants' confidence in their capacity to talk with a partner about sexual issues including using protection during sex (5 subscales, self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy)., immediately before and immediately after the intervention|Self-Efficacy in Relationships, Teen participants' confidence in their capacity to talk with a partner what they want and do not want in a relationship such as breaking up with someone they no longer like (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy)., immediately before and immediately after the intervention|Self-Efficacy for Consent, Teen participants' confidence in their capacity to talk with a partner about consent, including asking for consent for sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy)., immediately before and immediately after the intervention|Self-Efficacy for Communication with Teens about Sex, Father participants' confidence in their capacity to talk with their teen about sexual issues and relationships (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy)., immediately before and immediately after the intervention|Comfort Talking with Family about Sex, Participants' comfort to talk with their father/teen about sexual issues and relationships for fathers and teens including being able to talk openly and honestly about sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher comfort)., immediately before and immediately after the intervention|Open Communication Scale, Participants' comfort to talk with their father/teen about sex and relationships for fathers and teens including comfort talking through questions about sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher comfort)., immediately before and immediately after the intervention|Communication about Sex and Protection, Participants' reported frequency of talk with their father/teen about sex and relationships including talking with your father/teen about how to use condoms (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating more frequent communication)., immediately before and immediately after the intervention|Communication with family about sex & relationships, Participants' reported frequency of talk with their father/teen about sex and relationships including talk about value about sex and relationships (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating more frequent communication)., immediately before and immediately after the intervention|Frequency of Talk with Family about Sex and Relationships, Participants' reported frequency of talk with their father/teen about sex and relationships including when it is ok to have sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating more frequent communication)., immediately before and immediately after the intervention|Feasibility of Intervention Measure, Participants' experience of the program's accessibility including whether the program seems doable for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher feasibility)., immediately after the intervention|Feasibility, Participants' experience of the program's ease of use including whether the program was well-organized for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher feasibility)., immediately after the intervention|Acceptability of Intervention Measure, Participants' experience of the program including whether they approve of the program for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher acceptability)., immediately after the intervention|Intervention Acceptability and Tolerability, Participants' experience of the program's importance including whether they think the program was helpful for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher acceptability)., immediately after the intervention