Families Talking Together Plus: An Approach to Promote Sexual Delay and Strengthen Sexual Risk Avoidance Education

NCT ID: NCT04731649

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-09-27

Brief Summary

Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. Positive youth development (PYD) research has identified adolescent protective factors, such as success sequencing, self-regulation, goal setting, and strong family support [i.e., positive family development (PFD)] that are associated with increased sexual risk avoidance as well as individual life opportunities and societal benefits. Needed are programmatic efforts to strengthen adolescent protective factors among populations in greatest need, with a particular emphasis on the important role of parents in promoting sexual delay. The proposed project is designed to target Latino and Black adolescents aged 12-17 years residing in the South Bronx, New York City, a high-need community for sexual risk programming and promotion of adolescent life opportunities. The investigators evaluate a program called Families Talking Together Plus (FTT+), an online, parent-based intervention that is medically accurate, culturally tailored, and age-appropriate. To implement FTT +, the investigators draw upon an innovative and culturally competent intervention delivery approach, namely community health workers (CHWs) as "Life Opportunity Coaches."

Detailed Description

Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. The adverse short and long-term consequences of premature adolescent sexual behavior are well-documented, including negative effects on the physical, emotional, social, and economic well-being of youth. Positive youth development (PYD) research has identified adolescent protective factors, such as success sequencing, self-regulation, goal setting, and strong family support [i.e., positive family development (PFD)] that are associated with increased sexual risk avoidance as well as individual life opportunities and societal benefits.

Families Talking Together Plus (FTT +) is an online intervention designed to reduce adolescent sexual risk behavior through supporting caregiver-adolescent communication about sex. The goals of the program are to (1) delay sexual debut, (2) reduce sexual behavior, (3) increase correct and consistent condom use, and (4) increase engagement with community resources among Black and Latino adolescents aged 12-17 years (n=600) residing in a community with disparate adolescent SRH outcomes and high need for improved adolescent life opportunities and success sequencing support, the South Bronx, New York City.

The 2-arm parallel randomized controlled trial (RCT) will evaluate the efficacy of the FTT + intervention in delaying sexual debut, reducing adolescent sexual behavior, and linking adolescents to community resources and services for sexual risk behavior, PYD, and success sequencing. The investigators will recruit adolescents and the primary adult caregivers in the homes using area sampling methods piloted-tested by Center for Latino Adolescent and Family Health (CLAFH) staff with excellent results in our previous research in the target community. Parents and adolescents will complete a questionnaire (separately) at baseline assessments. Subsequently, parent-adolescent dyads will be randomly assigned to either, (1) the experimental group (who will receive the FTT + intervention), or (2) the control group that does not receive any intervention. The baseline sample size will be 600 dyads, with 300 dyads in each group.

Parents randomized to the experimental condition will receive three 60 to 90 minute virtual intervention sessions consisting of 9 modules delivered to the parent by community healthcare workers. Intervention sessions should happen within the first month following the baseline interview. FTT + modules address self-regulation, success sequencing, the benefits of delaying sex, correctly using a condom every time, healthy relationships, goal setting, resisting sexual coercion, dating violence, and other youth risk behaviors such as underage drinking or illicit drug use. In addition, parents receive guidance on effective adolescent monitoring and supervision and strengthening the relationship quality with the adolescent.

Conditions

Behavior and Behavior Mechanisms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Sex Education + Standard Care

The experimental arm will receive the FTT + intervention

Group Type: EXPERIMENTAL

Families Talking Together Plus (FTT +)

Intervention Type: BEHAVIORAL

FTT + consists of three online intervention sessions of approximately 60-90 minutes each, that cover content from nine modules designed to teach parents effective communication skills, build parent-adolescent relationships, help parents develop successful monitoring strategies, and teach adolescents assertiveness, refusal skills, and how to use a condom correctly and every time.

No Education + Standard Care

The control arm will not receive the FTT + intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Families Talking Together Plus (FTT +)

FTT + consists of three online intervention sessions of approximately 60-90 minutes each, that cover content from nine modules designed to teach parents effective communication skills, build parent-adolescent relationships, help parents develop successful monitoring strategies, and teach adolescents assertiveness, refusal skills, and how to use a condom correctly and every time.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adolescents must be between the ages of 12 and 17 years old
• Adolescent must identify as Latino or Black
• Adolescent has a primary caregiver
• Residence in Mott Haven, South Bronx

Exclusion Criteria

• Adolescent is not between the ages of 12-17
• Adolescent is not Latino or Black
• Adolescent does not have a primary caregiver
• Non-resident of Mott Haven, South Bronx

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Guilamo-Ramos, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

New York, New York, United States

Countries

United States

References

Guilamo-Ramos V, Benzekri A, Thimm-Kaiser M. Evaluating the efficacy of an online, family-based intervention to promote adolescent sexual health: a study protocol for a randomized controlled trial. Trials. 2023 Mar 11;24(1):181. doi: 10.1186/s13063-023-07205-3.

Reference Type: DERIVED

PMID: 36906589 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://link.springer.com/article/10.1186/s13063-023-07205-3

Study Protocol

Other Identifiers

90SR0113-01-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRO00108607

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00426772

Identifier Type: -

Identifier Source: org_study_id