Families Talking Together (FTT) in Texas
Condition: Sexual Risk Behavior
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Families Talking Together (FTT)
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Sexual and reproductive health; Promotores de Salud; Parent-adolescent communication; Health care insurance enrollment