- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994939
Families Talking Together (FTT) in Texas (FTT)
The National Campaign - FTT: A Family-based Teen Pregnancy Prevention Program in Texas
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 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
Exclusion Criteria:
- Self-identify as non-Latino
- Lack of parent or caregiver in home during recruitment
- Resident of non-target community in the Rio Grande Valley
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
|
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).
|
No Intervention: Control
Parents randomized to the control group did not receive any intervention sessions and only completed assessment questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Parent-Adolescent Communication about Sex and Contraception
Time Frame: 3 and 9 months post-baseline
|
Report of parent-adolescent communication about delay of sex and contraceptive use
|
3 and 9 months post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Parent-Adolescent Communication about HIV/STDs
Time Frame: 3 and 9 months post-baseline
|
Report of parent-adolescent communication about HIV/STIs
|
3 and 9 months post-baseline
|
Change in Sexual Risk Behaviors
Time Frame: 3 and 9 months post-baseline
|
Report of decrease in frequency of sex and/or increased condom use
|
3 and 9 months post-baseline
|
Change in Health Care Insurance Enrollment
Time Frame: 3 and 9 months post-baseline
|
Report of health care insurance enrollment among Latino families
|
3 and 9 months post-baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gillian Sealy, PhD, Power to Decide, The National Campaign to Prevent Unplanned Pregnancy
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PAWOS000011-01-00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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