Pilot of an Online Sexual Health Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pilot program study.
- Who it may be relevant to
- Registry conditions: Program, Communication. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot of a Father-based Intervention to Support Adolescents' Reproductive Health
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Wellesley College — Wellesley
Identifiers
NCT: NCT06564025 · 23139 · 1R21HD109744-01A1