NCT06564025

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

August 2, 2024

Last Update Submit

April 4, 2025

Conditions

Program, Communication

Keywords

sex educationfather-teen programfamily intervention

Outcome Measures

Primary Outcomes (14)

  • 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

Study Arms (1)

Pilot group for program

EXPERIMENTAL

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

Interventions

Pilot program studyBEHAVIORAL

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.

Pilot group for program

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellesley College

Wellesley, Massachusetts, 02481, United States

RECRUITING

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Jennifer Grossman, Ph.D.

CONTACT

781-283-2521jgrossma@wellesley.edu

Michelle Sullivan, Ph.D.

CONTACT

781-283-3277ms154@wellesley.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 21, 2024

Study Start

January 30, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL
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.
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.

Locations

US(1)