Recruiting

Sexual Health Program

Sponsor:

Wellesley College

Code:

NCT06564025

Conditions

Program, Communication

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Interventions

Pilot program study

Study Details

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.

Conditions

Program, Communication

Study ID

NCT06564025

Start date

Jan 30, 2025

Status verified date

Apr, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Sexual knowledge [ Time Frame: immediately before and immediately after the intervention ]
  • Sexual Communication Self-Efficacy Scale [ Time Frame: immediately before and immediately after the intervention ]
  • Self-Efficacy in Relationships [ Time Frame: immediately before and immediately after the intervention ]
  • Self-Efficacy for Consent [ Time Frame: immediately before and immediately after the intervention ]
  • Self-Efficacy for Communication with Teens about Sex [ Time Frame: immediately before and immediately after the intervention ]
  • Comfort Talking with Family about Sex [ Time Frame: immediately before and immediately after the intervention ]
  • Open Communication Scale [ Time Frame: immediately before and immediately after the intervention ]
  • Communication about Sex and Protection [ Time Frame: immediately before and immediately after the intervention ]
  • Communication with family about sex & relationships [ Time Frame: immediately before and immediately after the intervention ]
  • Frequency of Talk with Family about Sex and Relationships [ Time Frame: immediately before and immediately after the intervention ]
  • Feasibility of Intervention Measure [ Time Frame: immediately after the intervention ]
  • Feasibility: Participants' experience of the program's ease [ Time Frame: immediately after the intervention ]
  • Acceptability of Intervention Measure: whether participants approve of the program [ Time Frame: immediately after the intervention ]
  • Intervention Acceptability and Tolerability: Participants' experience of the program's importance [ Time Frame: immediately after the intervention ]

Central Contacts and Locations

Central contacts

Jennifer Grossman, Ph.D.

781-283-2521jgrossma@wellesley.edu

Michelle Sullivan, Ph.D.

781-283-3277ms154@wellesley.edu

Locations

Wellesley College

Recruiting

Wellesley, Massachusetts, United States, 02481

Contacts

Jennifer M Grossman, Ph.D.

781-283-2521jgrossma@wellesley.edu

Michelle Sullivan, Ph.D.

781-283-3277ms154@wellesley.edu

Principal Investigator:

Jennifer M Grossman, Ph.D.

More Information

Sponsor

Wellesley College

Last update posted

Apr 9, 2025

Last verified

Apr, 2025

Keywords

  • sex education
  • father-teen program
  • family intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wellesley College on 2025-04-09.