Online Sexual Health Program for Fathers and Teens

Overseen By Michelle Sullivan, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Wellesley College

Disqualifiers: Not a father, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Online Sexual Health Program for fathers and teens?

Research shows that online sexual health programs can be effective because they are widely accessible, comfortable, and can provide tailored information. Additionally, studies indicate that online interventions can empower individuals by increasing their health knowledge and encouraging them to seek further medical advice. ^{1 2 3 4 5}

Is the Online Sexual Health Program for Fathers and Teens safe for participants?

The research does not provide specific safety data for the Online Sexual Health Program for Fathers and Teens, but similar web-based sexual health programs have been used in public health settings without reported safety concerns. ^{6 7 8 9 10}

How does the Online Sexual Health Program for Fathers and Teens differ from other treatments for sexual health education?

This program is unique because it specifically involves fathers in the conversation about sexual health with their teens, addressing a gap where few programs engage parents, especially fathers. It is delivered online, making it accessible and scalable, and focuses on improving communication between fathers and teens about sex and relationships. ^{4 11 12 13 14}

Eligibility Criteria

This trial is for fathers aged 18 or older who have regular contact with their high-school aged teens. Participants must speak English, read at a 6th-grade level or higher, and be healthy enough to engage in online surveys, interventions, activities with their teen, and an online support group.

Inclusion Criteria

Have a reading level of 6th grade or above

I am capable of engaging in online activities and surveys.

Speak English

Exclusion Criteria

I am not a father of a high-school aged teen.

I cannot participate in studies in English.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online screener and consent forms

Intervention

Participants engage in a 3-week online intervention with modules including lessons, activities, and support groups

3 weeks

3 online modules, self-paced

Follow-up

Participants complete post-intervention surveys to assess changes in knowledge, self-efficacy, and communication

1 week

Online survey

Treatment Details

Interventions

• Online Sexual Health Program

Trial Overview The study tests an online program designed to help fathers discuss sex and relationships with their autistic teens. It's based on Social Cognitive Theory and checks if the program is liked, practical, and somewhat effective by looking at enrollment rates, feedback on lessons, how many stay until the end of the pilot study as well as changes in knowledge and confidence before and after the program.

Participant Groups

Group I: Pilot group for program Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Wellesley College

Lead Sponsor

Trials

6

Recruited

3,100+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Online interventions for cancer patients' sexual health have shown significant improvements in sexual function and interest, as well as addressing psychological aspects of sexual problems.

The review of four studies indicates that these interventions effectively combine education, interactive methods, and cognitive behavior therapy to support both cancer survivors and their partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online-based interventions for sexual health among individuals with cancer: a systematic review. Kang, HS., Kim, HK., Park, SM., et al.[2018]

The Men's Safer Sex website was developed to improve condom use among men, and a feasibility randomized controlled trial (RCT) involving 159 participants showed that while the intervention did not significantly reduce condomless sex or STI diagnoses compared to usual care, it provided valuable insights for future research.

Challenges included technical issues and low response rates for online questionnaires, but the study indicated that integrating digital health interventions with clinical services could be feasible, highlighting the need for improved software and data collection methods in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men. Bailey, JV., Webster, R., Hunter, R., et al.[2022]

The study involved 159 men from UK sexual health clinics and aimed to assess the feasibility of an online intervention for promoting safer sex, but faced significant challenges such as poor online response rates and technical issues.

While there was no significant difference in condomless sex between the intervention and control groups, the intervention group had a lower rate of new acute STI diagnoses (8.8% vs. 13.0%), suggesting potential benefits that warrant further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men. Bailey, JV., Webster, R., Griffin, M., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Sexual Health Advice Centre. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The University Hospital Zurich Offers a Medical Online Consultation Service for Men With Intimate Health Problems. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Online-based interventions for sexual health among individuals with cancer: a systematic review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of an online, family-based intervention to promote adolescent sexual health: a study protocol for a randomized controlled trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

An Electronic Sexual Health Module for Hospitalized Adolescent Girls. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Participant views and experiences of sexual health research: The Contraception Choices online trial. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

An Implementation Pilot of Web-Based Self-Training Programs on Sexual Dysfunctions in the Dutch Public Sexual Health Setting: Mixed Methods Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Medical students help bridge the gap in sexual health education among middle school youth. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Talking parents, healthy teens: a worksite-based program for parents to promote adolescent sexual health. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial to evaluate a web-based comprehensive sexual health and media literacy education program for high school students. [2020]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Moving from Needs Assessment to Intervention: Fathers' Perspectives on Their Needs and Support for Talk with Teens about Sex. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

A review of sexual health web sites for adolescents. [2012]