NCT03994939

Brief Summary

Power to Decide, The National Campaign to Prevent Teen and Unplanned Pregnancy, partnered with the Center for Latino Adolescent and Family Health at New York University's Silver School of Social Work, Healthy Futures of Texas, and the Rio Grande Valley Council to implement Families Talking Together (FTT), an evidence-based teen pregnancy prevention program in Texas. This was a randomized clinical trial of a parent-based sexual and reproductive health intervention (SRH) to foster parent-adolescent communication about sex among Latino adolescents. The FTT intervention focuses on the parenting practices that are important to supporting healthy adolescent sexual behavior. As part of the intervention, families also received a module on the Affordable Care Act (ACA) to influence greater linkages to health care.The study was conducted with 634 parent-adolescent dyads in Willacy, Starr, Hidalgo, and Cameron counties in South Texas. Parent-adolescent dyads completed a baseline survey and were allocated to either an experimental or control group. Participating dyads completed follow-up surveys 3 and 9 months' post-baseline assessment. The proposed outcomes of the study were increased adolescent report of parent-adolescent communication about sex, decrease in sexual risk behaviors (e.g., sexual debut) as well as increased health care insurance enrollment among Latino families.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
634

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

December 5, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

June 18, 2019

Last Update Submit

June 20, 2019

Conditions

Sexual Risk Behavior

Keywords

Sexual and reproductive healthPromotores de SaludParent-adolescent communicationHealth care insurance enrollment

Outcome Measures

Primary Outcomes (1)

  • Change in Parent-Adolescent Communication about Sex and Contraception

    Report of parent-adolescent communication about delay of sex and contraceptive use

    3 and 9 months post-baseline

Secondary Outcomes (3)

  • Change in Parent-Adolescent Communication about HIV/STDs

    3 and 9 months post-baseline

  • Change in Sexual Risk Behaviors

    3 and 9 months post-baseline

  • Change in Health Care Insurance Enrollment

    3 and 9 months post-baseline

Study Arms (2)

Intervention

EXPERIMENTAL

Received Families Talking Together (FTT) intervention, an evidence-based program designed to increase parent-adolescent communication about sex in order to delay sexual debut and prevent negative sexual and reproductive health outcomes in adolescents age 10-14. The FTT intervention consisted of two components. Component 1 was comprised of 2 FTT intervention sessions between a parent and bilingual/bicultural promotor trained to deliver FTT in English or Spanish. These sessions highlighted adverse health consequences of sex to motivate parents to communicate with their adolescent and provided guidance to parents on communication strategies. Component 2 was comprised of written supplemental materials that promotores used to guide each intervention session. Experimental condition families will complete all measurement assessments.

Behavioral: Families Talking Together (FTT)

Control

NO INTERVENTION

Parents randomized to the control group did not receive any intervention sessions and only completed assessment questionnaires.

Interventions

Families Talking Together (FTT)BEHAVIORAL

FTT is an evidence-based program designed to increase parent-adolescent communication about sex in order to delay sexual debut and prevent negative SRH outcomes in young adolescents (aged 10 to 14). The FTT intervention has been delivered with efficacy in multiple settings, including schools and clinics (Guilamo-Ramos et al., 2011a; Guilamo-Ramos et al., 2011b).

Intervention

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Self-identify as Latino
  • At least one a parent present in home, defined as a biological or non-biological primary caregiver
  • Resident of target geographic community (Willacy, Starr, Hidalgo, or Cameron) in the Rio Grande Valley

You may not qualify if:

  • Self-identify as non-Latino
  • Lack of parent or caregiver in home during recruitment
  • Resident of non-target community in the Rio Grande Valley

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Guilamo-Ramos V, Bouris A, Jaccard J, Gonzalez B, McCoy W, Aranda D. A parent-based intervention to reduce sexual risk behavior in early adolescence: building alliances between physicians, social workers, and parents. J Adolesc Health. 2011 Feb;48(2):159-63. doi: 10.1016/j.jadohealth.2010.06.007.

    PMID: 21257114BACKGROUND

  • Guilamo-Ramos V, Jaccard J, Dittus P, Bouris A, Gonzalez B, Casillas E, Banspach S. A comparative study of interventions for delaying the initiation of sexual intercourse among Latino and black youth. Perspect Sex Reprod Health. 2011 Dec;43(4):247-54. doi: 10.1363/4324711. Epub 2011 Nov 15.

    PMID: 22151512BACKGROUND

  • Office of Adolescent Health. (2017). Families Talking Together (FTT). Retrieved from http://www.hhs.gov/ash/oah/oah-initiatives/tpp_program/db/programs/ebp-ftt.html.

    BACKGROUND

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Gillian Sealy, PhD

    Power to Decide, The National Campaign to Prevent Unplanned Pregnancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A computer random number generation program was used to create a randomly permutated scheme that assigned specific subject identification numbers to either the experimental or passive control group in a one-to-one ratio. An allocation sequence was generated by the principal investigator. Each experimental/control group allocation sequence was placed in a sealed envelope which remained concealed until after participants had enrolled into the study. After the baseline was completed, the sealed envelope was opened with the family's allocation tied to their specific ID. Data collectors administering the immediate and delayed follow-up surveys were blinded to the condition of participants.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two-arm parallel RCT designed to test the efficacy of a teen pregnancy prevention program conducted in the Rio Grande Valley from 2013-2018. Parent-adolescent dyads were randomly assigned to either a passive control group that received no intervention or an experimental group which received the promotor delivered family-based SRH prevention program Families Talking Together (FTT) with added Affordable Care Act (ACA) module.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 21, 2019

Study Start

December 5, 2015

Primary Completion

June 15, 2017

Study Completion

August 31, 2018

Last Updated

June 21, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share