Pilot of an Online Sexual Health Program

Pilot of a Father-based Intervention to Support Adolescents' Reproductive Health

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.

Study Overview

• Status: Recruiting
• Conditions: Program, Communication
• Intervention / Treatment: Behavioral: Pilot program study

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Grossman, Ph.D.; Phone Number: 781-283-2521; Email: jgrossma@wellesley.edu
• Study Contact Backup: Name: Michelle Sullivan, Ph.D.; Phone Number: 781-283-3277; Email: ms154@wellesley.edu

Study Locations

• United States
  • Massachusetts
    • Wellesley, Massachusetts, United States, 02481
      • Recruiting
      • Wellesley College
      • Contact: Michelle Sullivan, Ph.D.; Phone Number: 781-283-3277; Email: ms154@wellesley.edu
      • Contact: Jennifer M Grossman, Ph.D.; Phone Number: 781-283-2521; Email: jgrossma@wellesley.edu
      • Contact: Jennifer M Grossman, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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: whether participants approve of the program	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	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

Collaborators and Investigators

• Sponsor: Wellesley College
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: family intervention; sex education; father-teen program
• Other Study ID Numbers: 23139 (Other Identifier: City of Hope Medical Center); 1R21HD109744-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Documentation to be made publicly available to the research community will include pilot surveys and interview protocols, along with a detailed User Guide for interviews. A survey codebook will include a description of all items and survey measures as well as variable names, variable labels, and standard codes for missing values. Interview data will include a description of recoded data categories. We expect study data and associated documentation will be made available to the research community free of charge through the Inter-university Consortium for Political and Social Research (ICPSR).
• IPD Sharing Time Frame: Final submission and release of the study data will occur approximately 1 year following the end of fieldwork. Study data deposited in the Inter-university Consortium for Political and Social Research will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date as appropriate.

IPD Sharing Access Criteria

Deidentified pilot survey data will be made available as public use data to the research community via the Inter-university Consortium for Political and Social Research (ICPSR). Users of this data must register with ICPSR and agree to the Terms of Use. Data users also agree not to share or redistribute any data downloads.

Recoded interview data that is determined to be potentially identifying through indirect or deductive disclosure are provided under restricted data contract to users who demonstrate a valid research need and meet conditions of use.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No