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


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
11 Mar 2023
Historique:
received: 22 11 2022
accepted: 28 02 2023
entrez: 11 3 2023
pubmed: 13 3 2023
medline: 15 3 2023
Statut: epublish

Résumé

Adolescents in the U.S. experience significant negative sexual health outcomes, representing a public health priority in the U.S. Research shows that while parents play an influential role in shaping adolescent sexual behavior, surprisingly few programs engage parents in existing programming. Moreover, most efficacious parent-based programs focus on young adolescents, and few utilize delivery mechanisms that facilitate broad reach and scale-up. To address these gaps, we propose to test the efficacy of an online-delivered, parent-based intervention adapted to address both younger and older adolescent sexual risk behavior. In this parallel, two-arm, superiority randomized controlled trial (RCT), we propose to evaluate Families Talking Together Plus (FTT+), an adaptation of an existing and efficacious FTT parent-based intervention, in shaping sexual risk behavior among adolescents aged 12-17 and delivered via a teleconferencing application (e.g., Zoom). The study population will include n=750 parent-adolescent dyads recruited from public housing developments in the Bronx, New York. Adolescents will be eligible if they are between the ages of 12 and 17 years of age, self-report as Latino and/or Black, have a parent or primary caregiver, and are South Bronx residents. Parent-adolescent dyads will complete a baseline survey, after which they will be assigned to either the FTT+ intervention condition (n=375) or the passive control condition (n=375) in a 1:1 allocation ratio. Parents and adolescents in each condition will complete follow-up assessments 3 and 9 months post-baseline. The primary outcomes will include sexual debut and ever sex, and the secondary outcomes will include the frequency of sex acts, number of lifetime sexual partners, number of unprotected sex acts, and linkage to health and educational/vocational services in the community. We will utilize intent-to-treat analyses of 9-month outcomes and single degree of freedom contrasts comparing the intervention to the control group for primary and secondary outcomes. The proposed evaluation and analysis of the FTT+ intervention will address gaps in the current cadre of parent-based programs. If efficacious, FTT+ would represent a model for scale-up and adoption of parent-based approaches designed to address adolescent sexual health in the U.S. ClinicalTrials.gov NCT04731649. Registered on February 1, 2021.

Sections du résumé

BACKGROUND BACKGROUND
Adolescents in the U.S. experience significant negative sexual health outcomes, representing a public health priority in the U.S. Research shows that while parents play an influential role in shaping adolescent sexual behavior, surprisingly few programs engage parents in existing programming. Moreover, most efficacious parent-based programs focus on young adolescents, and few utilize delivery mechanisms that facilitate broad reach and scale-up. To address these gaps, we propose to test the efficacy of an online-delivered, parent-based intervention adapted to address both younger and older adolescent sexual risk behavior.
METHODS METHODS
In this parallel, two-arm, superiority randomized controlled trial (RCT), we propose to evaluate Families Talking Together Plus (FTT+), an adaptation of an existing and efficacious FTT parent-based intervention, in shaping sexual risk behavior among adolescents aged 12-17 and delivered via a teleconferencing application (e.g., Zoom). The study population will include n=750 parent-adolescent dyads recruited from public housing developments in the Bronx, New York. Adolescents will be eligible if they are between the ages of 12 and 17 years of age, self-report as Latino and/or Black, have a parent or primary caregiver, and are South Bronx residents. Parent-adolescent dyads will complete a baseline survey, after which they will be assigned to either the FTT+ intervention condition (n=375) or the passive control condition (n=375) in a 1:1 allocation ratio. Parents and adolescents in each condition will complete follow-up assessments 3 and 9 months post-baseline. The primary outcomes will include sexual debut and ever sex, and the secondary outcomes will include the frequency of sex acts, number of lifetime sexual partners, number of unprotected sex acts, and linkage to health and educational/vocational services in the community. We will utilize intent-to-treat analyses of 9-month outcomes and single degree of freedom contrasts comparing the intervention to the control group for primary and secondary outcomes.
DISCUSSION CONCLUSIONS
The proposed evaluation and analysis of the FTT+ intervention will address gaps in the current cadre of parent-based programs. If efficacious, FTT+ would represent a model for scale-up and adoption of parent-based approaches designed to address adolescent sexual health in the U.S.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov NCT04731649. Registered on February 1, 2021.

Identifiants

pubmed: 36906589
doi: 10.1186/s13063-023-07205-3
pii: 10.1186/s13063-023-07205-3
pmc: PMC10008101
doi:

Banques de données

ClinicalTrials.gov
['NCT04731649']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

181

Subventions

Organisme : ACF HHS
ID : 90SR0113-01-00
Pays : United States

Informations de copyright

© 2023. The Author(s).

Références

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Auteurs

Vincent Guilamo-Ramos (V)

Center for Latino Adolescent and Family Health, Duke University School of Nursing, Durham, NC, USA. vincent.ramos@duke.edu.
School of Nursing, Duke University, 307 Trent Dr, Durham, NC, 27710, USA. vincent.ramos@duke.edu.
School of Medicine, Department of Family Medicine and Community Health, Department of Infectious Diseases, Duke University, 40 Duke Medicine Circle, Durham, NC, USA. vincent.ramos@duke.edu.
Presidential Advisory Council on HIV AIDS, U.S. Department of Health and Human Services, Washington, D.C., USA. vincent.ramos@duke.edu.

Adam Benzekri (A)

Center for Latino Adolescent and Family Health, Duke University School of Nursing, Durham, NC, USA.
School of Nursing, Duke University, 307 Trent Dr, Durham, NC, 27710, USA.

Marco Thimm-Kaiser (M)

Center for Latino Adolescent and Family Health, Duke University School of Nursing, Durham, NC, USA.
School of Nursing, Duke University, 307 Trent Dr, Durham, NC, 27710, USA.

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Classifications MeSH