Sexual Risk Behavior Clinical Trial
Official title:
The National Campaign - FTT: A Family-based Teen Pregnancy Prevention Program in Texas
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.
The study was a 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 an added Affordable Care Act (ACA) module.
Parent-adolescent dyads completed baseline, immediate post-baseline (3 months) and delayed
(9-month) follow-up assessments.
A combination of venue-based and area sampling methods was used in 4 Rio Grande Valley
counties to recruit Latino adolescents and their parents residing in colonias for study
participation. The 4 counties (Willacy, Starr, Hidalgo, Cameron) were chosen due to well
documented SRH disparities among youth.Trained recruitment promotores attended local
community health fairs, shopping malls, supermarkets, etc. where large numbers of resident
families could be engaged. During these events, recruitment promotores made initial contact
with potentially eligible youth and their families in order to screen for study inclusion
criteria. In addition, recruiters went door-to-door in targeted communities conducting active
outreach and engagement of families directly within their homes. Eligible families were
informed that they were being asked to participate in a research project seeking to improve
access to SRH programming for adolescents and that participation would require, at minimum,
participating in a survey now as well as after 3 and 9 months. We obtained informed assent
and parental consent for all adolescents participating in the study. Parents provided their
consent to participate.Refusal bias data was collected as part of the screening process.
Refusal data suggested no significant differences between those families declining to
participate and those agreeing to be part of the study.
Adolescents and their parents completed baseline, immediate post-baseline (3 months), and
delayed follow-up (9 months) assessments using self-administered surveys in either English or
Spanish, based on preference. Prior to initiation of the RCT, surveys were pilot tested to
ensure conceptual clarity and linguistic appropriateness. To ensure confidentiality, parents
and adolescents completed questionnaires separately. A social desirability scale was included
in the measurement protocol to assess the extent to which participant responses reflect
social desirability bias.
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.
Parents randomized to the experimental group received the 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 SRH outcomes in young
adolescents (aged 10 to 14). The FTT intervention has been delivered with efficacy in
multiple settings, including schools and clinics. FTT is also identified by the United States
Department of Health and Human Services and the Office of Adolescent Health (OAH) as a high
quality, effective prevention program. The FTT intervention consisted of two components.
Intervention component 1 was comprised of two FTT intervention sessions between a parent and
the bilingual and bicultural promotor trained to deliver FTT in either English or Spanish.
Intervention sessions were delivered to parents in their home or a mutually agreed upon
private location in the community. Intervention component 2 was comprised of written
supplemental materials that promotores used to guide each intervention session. Written
materials included a family FTT workbook and a short story entitled 'Victor and Maria.'
During each intervention session, promotores reviewed the intervention materials and
instructed parents how to structure conversations about delaying sexual debut and the use of
contraception with their adolescent. At three and 9 months post-baseline, adolescents in the
experimental and control groups completed follow-up surveys administered by data collectors.
To examine group differences in parent-adolescent communication variables, ordinary least
squares (OLS) regression was used. To ensure baseline equivalence between the two arms of the
RCT, demographic and outcome variables were compared at baseline between the intervention and
control groups. In order to assess the generalizability of results across traditional and
robust methods of analysis, all analyses were repeated with bootstrapping. Additionally,
outlier and specification-error for each analysis was conducted.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05889689 -
Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters
|
N/A | |
Withdrawn |
NCT00914719 -
Alcohol Use and Sexual Risk: An Intervention
|
N/A | |
Completed |
NCT03855410 -
Preventing Cigarette Use Among Urban Youth Via an M-Health Primary Care Preventive Intervention
|
N/A | |
Completed |
NCT01970293 -
AA Linkage for Alcohol Abusing Women Leaving Jail
|
N/A | |
Completed |
NCT01395979 -
HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories
|
N/A | |
Recruiting |
NCT06223165 -
Optimizing the Floreciendo Sexual and Reproductive Health Workshop for Latina Teens and Female Caregivers: A Pilot
|
N/A | |
Completed |
NCT02188797 -
Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
|
N/A | |
Completed |
NCT00447707 -
Positive Choice: Prevention for Positive Health
|
N/A | |
Completed |
NCT03009539 -
eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care
|
N/A |