Federal Evaluation of Selected Programs for Expectant and Parenting Youth (PEPY)

August 23, 2018 updated by: Mathematica Policy Research, Inc.

Understanding the Effectiveness of Healthy Families Healthy Futures in Houston, Texas

Under contract to the U.S. Department of Health and Human Services (DHHS), Mathematica Policy Research is conducting an impact study of Healthy Families Healthy Futures in Houston, Texas for a Federal Evaluation of Programs for Expectant and Parenting Youth (PEPY). The impact study will be designed to address three main questions:

  • Was the program successful in exposing participants to program content, such as information about methods of birth control?
  • Was the program successful at improving short-term outcomes, such as use of a LARC and intention to space births?
  • To what extent did treatment youth receive the intended program components?

Study Overview

Detailed Description

A random assignment design will be used to assess the program's impact on exposure to program content and short term outcomes. Potential study participants were recruited between June 2015 and October 2016, and were considered eligible for participation if they were first time mothers between the ages of 14 and 19, English or Spanish speakers, had not enrolled in the program in the previous six mounts, and were not enrolled in the Nurse Family Partnership program. Potential participants who were eligible and who consented to participate were randomly assigned to (1) a treatment group that was eligible for Healthy Families Healthy Futures (HFHF) services or (2) a control group that was not eligible for HFHF. Random assignment was conducted within two blocks determined by whether study participants were pregnant at the time of random assignment or were parenting at the time of random assignment. The study draws on data from HFHF administrative records on service receipt, a baseline survey administered prior to random assignment, and a follow-up survey administered approximately 12 months after random assignment.

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77002
        • Houston Department of Health; participants' homes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

• Must be expectant or parenting

Exclusion Criteria:

  • Participated in HFHF in six months prior to random assignment
  • Enrolled in Nurse Family Partnership program at time of random assignment
  • Oldest child is older than 3 months at random assignment
  • Primary language is neither English nor Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Families, Healthy Futures
Family coaches meet with participating pregnant and parenting females, the woman's partner, and the child. Visit frequency varies from once per week to once per month, depending on the length of time in the program, the client's needs, and the accomplishment of program milestones. In the short term, the program seeks to increase the use of Long-Acting Reversible Contraception (LARC), enhance family functioning including improving father involvement, and to meet the baby's child development needs. In the long term, the program aims to delay subsequent pregnancies, ensure positive child development, and increase parents' self-sufficiency.
Home visiting program for pregnant and parenting teens
No Intervention: Control group
No active treatment for control group. Control group has access to "business as usual" services in community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exposure to information on relationships, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
Time Frame: 12 months
Binary variable: equal to one if respondent reported attending a class or session (individual or group) about relationships, dating, or marriage
12 months
Exposure to information on parenting, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
Time Frame: 12 months
: Binary variable: equal to one if respondent reported attending a class or session (individual or group) about parenting or how to care for their child
12 months
Exposure to information on child healthcare, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
Time Frame: 12 months
Binary variable: equal to one if respondent reported attending a class or session (individual or group) about how to get insurance or apply for Medicaid for their child and where to get health care for their child
12 months
Exposure to education related services, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
Time Frame: 12 months
Binary variable: equal to one if respondent reported participating in GED preparation, tutoring, or outside help with school work, or program to prepare for a high school diploma
12 months
Exposure to career counseling or job training, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
Time Frame: 12 months
Binary variable: equal to one if respondent reported participating in career counseling or job training
12 months
Exposure to information about methods of birth control, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
Time Frame: 12 months
Binary variable: equal to one if respondent reported receiving information from doctor, nurse, home visitor, or clinic regarding methods of birth control
12 months
Knowledge of condoms
Time Frame: 12 months
Continuous variable that is the proportion correct of a mother's responses to six survey items about her knowledge of condoms; each of the six individual item is binary, indicating correct (individual item=1) or incorrect (individual item=0).The proportion correct ranges from 0 to 1, with higher values indicating greater knowledge. Items collected using the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Knowledge of birth control pills
Time Frame: 12 months
Continuous variable that is the proportion correct of a mother's responses to five survey items about her knowledge of birth control pills; each of the five individual items is binary, indicating correct (individual item=1) or incorrect (individual item=0). The proportion correct ranges from 0 to 1, with higher values indicating great knowledge. Items collected using the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Knowledge of IUDs
Time Frame: 12 months
Continuous variable that is the proportion correct of a mother's responses to six survey items about her knowledge of IUDs; each of the six individual items is binary, indicating correct (individual item=1) or incorrect (individual item=0). The proportion correct can range from 0 to 1, with higher values indicating greater knowledge. Items collected using the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Knowledge of other hormonal and LARC methods
Time Frame: 12 months
Continuous variable that is the proportion correct of a mother's responses to five survey items about her knowledge of other forms of birth control; each of the five individual items is binary, indicating correct (individual item=1) or incorrect (individual item=0) responses. The proportion correct ranges from 0 to 1, with higher values indicating greater knowledge.
12 months
Use of a LARC
Time Frame: 12 months
Binary measure equal to one if the respondent indicated using an IUD or an implant, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Unprotected sex
Time Frame: 12 months
Binary measure equal to one if the respondent indicated having sexual intercourse in the 3 months prior to the survey and having had sexual intercourse without using birth control, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Intention to space births
Time Frame: 12 months
Binary variable: equal to one if the woman reports she would like to have her next child two to three years or more than three years from the date of the survey or does not want any more children, and zero if she reports wanting to have her next child less than one year or one to two years from the date of the survey or is pregnant at the time of the survey, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Mother's engagement in play with child
Time Frame: 12 months
Multiple-item continuous scale variable that is the average of a mother's responses to five individual categorical survey items; variable ranges from 0 to 3 with higher values indicating more frequent interaction with child. Individual items measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Father's engagement with child
Time Frame: 12 months
Multiple-item continuous scale variable: average of a mother's responses to eight survey items about her HFHF child's father; variable ranges from 0 to 3 with higher values indicating more frequent interaction with child. Survey items are from the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Quality of co-parenting relationship
Time Frame: 12 months
Multiple-item continuous scale variable: average of mother's responses to seven survey items; variable ranges from 1 to 5 with higher values indicating a stronger co-parenting relationship. Survey items collected using the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Financial support from father
Time Frame: 12 months
Binary variable: equal to one if mother reports that her child's father covers about half or more of the expenses associated with raising their child and zero if mother reports that her child's father covers less than half of child's costs as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Capacity for self-sufficiency- Goals, plans, problem solving
Time Frame: 12 months
Multiple-item continuous scale variable: average of a mother's responses to seven survey items about her goals, focus, and problem solving. Each item ranges from 1 to 4, with higher numbers corresponding to stronger agreement. Items measured using the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Number of well visits
Time Frame: 12 months
Count variable equal to the respondent's reported number of times in which the child saw a doctor, nurse, or other health care professional for a regular checkup, as reported on the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months
Health insurance for child
Time Frame: 12 months
Binary variable equal to one if the respondent reported having health insurance for her child, as reported on the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John Deke, Mathematica Policy Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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