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NCT Number: NCT06564025

Pilot of an Online Sexual Health Program

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.

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Key information

Conditions

Program, Communication Behavior Communication

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pilot program study

Behavioral

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 outcomes

  1. Sexual knowledge

    Time frame: immediately before and immediately after the intervention

    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).

  2. Sexual Communication Self-Efficacy Scale

    Time frame: immediately before and immediately after the intervention

    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).

  3. Self-Efficacy in Relationships

    Time frame: immediately before and immediately after the intervention

    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).

  4. Self-Efficacy for Consent

    Time frame: immediately before and immediately after the intervention

    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).

  5. Self-Efficacy for Communication with Teens about Sex

    Time frame: immediately before and immediately after the intervention

    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).

  6. Comfort Talking with Family about Sex

    Time frame: immediately before and immediately after the intervention

    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).

  7. Open Communication Scale

    Time frame: immediately before and immediately after the intervention

    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).

  8. Communication about Sex and Protection

    Time frame: immediately before and immediately after the intervention

    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).

  9. Communication with family about sex & relationships

    Time frame: immediately before and immediately after the intervention

    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).

  10. Frequency of Talk with Family about Sex and Relationships

    Time frame: immediately before and immediately after the intervention

    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).

  11. Feasibility of Intervention Measure

    Time frame: immediately after the intervention

    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).

  12. Feasibility: Participants' experience of the program's ease

    Time frame: immediately after the intervention

    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).

  13. Acceptability of Intervention Measure: whether participants approve of the program

    Time frame: immediately after the intervention

    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).

  14. Intervention Acceptability and Tolerability: Participants' experience of the program's importance

    Time frame: immediately after the intervention

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Grossman, Ph.D.

CONTACT

[email protected]

781-283-2521

Michelle Sullivan, Ph.D.

CONTACT

[email protected]

781-283-3277

Sponsors and collaborators

Lead sponsor

Wellesley College

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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