Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564025
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Pilot of an Online Sexual Health Program
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot of a Father-based Intervention to Support Adolescents Reproductive Health
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 interventions 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 interventions 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 N50 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 fatherteen pairs who complete the screeners and consentassent 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 fatherteen 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
The investigators will recruit a diverse sample of father-adolescent pairs N50 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 fatherteen pairs who complete the screeners and consentassent 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 fatherteen 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None