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The purpose of this research study is to evaluate a brief parent-based adolescent sexual health intervention called Families Talking Together Plus (FTT+). FTT+ is based on an established intervention called Families Talking Together (FTT) and will enhance FTT by adding modules on human papillomavirus (HPV). The goal of the study is to evaluate whether FTT will help parents increase sexual health communication, delay adolescent sexual debut, and increase HPV vaccination. FTT will be delivered to parents of minority youth and will be delivered by student nurses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Families Talking Together Plus (FTT+HPV) | Experimental | Parents in the experimental group will attend a 1-hour intervention session, receive program materials to use with youth at home, and receive 2 booster phone calls post-intervention. Content of the experimental intervention includes parent-child sexual health communication and HPV vaccination navigation. |
|
| Brief motivational interviewing (BMI) | Active Comparator | Parents in the brief motivational interviewing (BMI) group will attend a 1-hour intervention session, receive program materials to use with youth at home, and receive 2 booster phone calls post-intervention. Content of the control intervention includes obesity prevention strategies using motivational interviewing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Families Talking Together Plus (FTT+HPV) | Behavioral | Intervention parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the experimental intervention includes parent child sexual health communication and HPV vaccination navigation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in parent child communication as assessed by the Families Talking Together Plus HPV (FTT + HPV) survey administered to parents | The FTT + HPV survey is a survey that has been developed by the investigator for this study. The survey is administered at baseline, 1, and 6 months using iPads and is available as Audio Computer-Assisted Self-Interviews in both English and Spanish. | 1 month |
| Change in parent child communication as assessed by the FTT + HPV survey administered to parents | 6 months | |
| Change in intentions for sex as assessed by the FTT + HPV survey administered to youths | 1 month | |
| Change in intentions for sex as assessed by the FTT + HPV survey administered to youths | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in parental monitoring as assessed by the FTT + HPV survey administered to parents | 1 month | |
| Change in parental monitoring as assessed by the FTT + HPV survey administered to parents | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses | 1 month | |
| Change in confidence as sex educators as assessed by the FTT + HPV survey administered to student nurses | 6 months |
Age limit for parents: minimum = N/A (No limit); maximum = N/A (No limit) Age limit for children: minimum = 11 years; maximum = 14 years
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Santa Maria, DrPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37817237 | Derived | Coleman DC, Frederick A, Cron S, Markham C, Guilamo-Ramos V, Santa Maria D. Impact of preparing nursing students to deliver a parent-based sexual health intervention on attitudes and intentions for sexual health education and parent communication counseling: a mixed methods study. BMC Nurs. 2023 Oct 10;22(1):375. doi: 10.1186/s12912-023-01531-2. | |
| 33761920 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2015 | Oct 30, 2023 | ICF_000.pdf |
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|
| Brief motivational interviewing (BMI) | Behavioral | Control parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the control intervention includes obesity prevention strategies using motivational interviewing. |
|
| Change in parental involvement as Assessed by the FTT + HPV survey administered to parents | 1 month |
| Change in parental involvement as assessed by the FTT + HPV survey administered to parents | 6 months |
| Change in intentions for communication as assessed by the FTT + HPV survey administered to parents | 1 month |
| Change in intentions for communication as assessed by the FTT + HPV survey administered to parents | 6 months |
| Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents | 1 month |
| Change in intentions for HPV vaccination of child as assessed by the FTT + HPV survey administered to parents | 6 months |
| Change in sexual activity as assessed by the FTT + HPV survey administered to youths | 1 month |
| Change in sexual activity as assessed by the FTT + HPV survey administered to youths | 6 months |
| Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths | 1 month |
| Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to youths | 6 months |
| Change in parental communication as assessed by the FTT + HPV survey administered to youths | 1 month |
| Change in parental communication as assessed by the FTT + HPV survey administered to youths | 6 months |
| Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths | 1 month |
| Change in HPV vaccine received as assessed by the FTT + HPV survey administered to youths | 6 months |
| Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses | 1 month |
| Change in intentions to endorse HPV vaccination as assessed by the FTT + HPV survey administered to student nurses | 6 months |
| Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to student nurses | 1 month |
| Change in knowledge of HPV risk factors as assessed by the FTT + HPV survey administered to student nurses | 6 months |
| Change in beliefs as assessed by the FTT + HPV survey administered to student nurses | 1 month |
| Change in beliefs as assessed by the FTT + HPV survey administered to student nurses | 6 months |
| Santa Maria D, Markham C, Misra SM, Coleman DC, Lyons M, Desormeaux C, Cron S, Guilamo-Ramos V. Effects of a randomized controlled trial of a brief, student-nurse led, parent-based sexual health intervention on parental protective factors and HPV vaccination uptake. BMC Public Health. 2021 Mar 24;21(1):585. doi: 10.1186/s12889-021-10534-0. |