NCT04731649

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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

3.6 years

First QC Date

January 26, 2021

Last Update Submit

October 9, 2024

Conditions

Behavior and Behavior Mechanisms

Keywords

Families Talking TogetherAdolescent Sexual HealthCommunity Health WorkersPrevention

Outcome Measures

Primary Outcomes (3)

  • Sexual Debut/Ever Sex (Vaginal)

    Defined as adolescent report of having engaged in vaginal sex.

    9-month post-intervention

  • Sexual Debut/Ever Sex (Anal)

    Defined as adolescent report of having engaged in anal sex.

    9-month post-intervention

  • Sexual Debut/Ever Sex (Oral)

    Defined as adolescent report of having engaged in oral sex.

    9-month post-intervention

Secondary Outcomes (17)

  • Frequency of Vaginal Sex Acts

    9-month post-intervention

  • Frequency of Anal Sex Acts

    9-month post-intervention

  • Frequency of Oral Sex Acts

    9-month post-intervention

  • Number of Sexual Partners

    9-month post-intervention

  • Adolescent Consistency of Condom Use: As Measured by the Condom Use Among Hispanics Scale

    9-month post-intervention

  • +12 more secondary outcomes

Study Arms (2)

Sex Education + Standard Care

EXPERIMENTAL

The experimental arm will receive the FTT + intervention

Behavioral: Families Talking Together Plus (FTT +)

No Education + Standard Care

NO INTERVENTION

The control arm will not receive the FTT + intervention

Interventions

Families Talking Together Plus (FTT +)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.

Sex Education + Standard Care

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

New York, New York, 10017, United States

Location

Related Publications (1)

  • 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.

    PMID: 36906589DERIVED

Related Links

MeSH Terms

Conditions

Behavior

Study Officials

  • Vincent Guilamo-Ramos, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 1, 2021

Study Start

March 1, 2021

Primary Completion

September 27, 2024

Study Completion

September 27, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)