- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03419728
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
Unknown
Conditions
Intervention / Treatment
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
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Texas
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Houston, Texas, United States, 77002
- Houston Department of Health; participants' homes
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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.
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Home visiting program for pregnant and parenting teens
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No Intervention: Control group
No active treatment for control group.
Control group has access to "business as usual" services in community.
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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
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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"
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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"
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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.
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12 months
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Use of a LARC
Time Frame: 12 months
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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"
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12 months
|
Unprotected sex
Time Frame: 12 months
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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"
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12 months
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Intention to space births
Time Frame: 12 months
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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"
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12 months
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Mother's engagement in play with child
Time Frame: 12 months
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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"
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12 months
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Father's engagement with child
Time Frame: 12 months
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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"
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12 months
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Quality of co-parenting relationship
Time Frame: 12 months
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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"
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12 months
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Financial support from father
Time Frame: 12 months
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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"
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12 months
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Capacity for self-sufficiency- Goals, plans, problem solving
Time Frame: 12 months
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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"
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12 months
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Number of well visits
Time Frame: 12 months
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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"
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12 months
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Health insurance for child
Time Frame: 12 months
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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"
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12 months
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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
Keywords
Other Study ID 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.
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