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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Healthy Families, Healthy Futures
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mathematica Policy Research, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Office of Adolescent Health, HHS
Decision Information Resources, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 50023

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.

Clinical Trials on Contraceptive Usage

Clinical Trials on Healthy Families, Healthy Futures

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings