Evaluating the efficacy of an online, family-based intervention to promote adolescent sexual health: a study protocol for a randomized controlled trial.
Adolescents
HIV
Parents
STI
Sexual and reproductive health
Teen pregnancy
Unprotected sex acts
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
11 Mar 2023
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
181Subventions
Organisme : ACF HHS
ID : 90SR0113-01-00
Pays : United States
Informations de copyright
© 2023. The Author(s).
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