ClinicalTrials.gg
Status unknownNCT03419728PEPYUpdated Aug 24, 2018

Federal Evaluation of Selected Programs for Expectant and Parenting Youth

An interventional study of Healthy Families, Healthy Futures in Teen Pregnancy Prevention and Contraceptive Usage, sponsored by Mathematica Policy Research, Inc.. Status unknown at 1 site in United States. Open to female participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2018-08-24.

Sponsored by Mathematica Policy Research, Inc. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Jun 2015, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
14 Years to 19 Years
Sex
Female
01

Study summary

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?
Read the 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.

02

Conditions studied

  • Teen Pregnancy Prevention
  • Contraceptive Usage

Keywords

  • Teen pregnancy prevention
  • Long-acting reversible contraception (LARCs)
  • Healthy Families Healthy Futures
  • Home visiting
03

In context

Contraception Behavior

132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.

This study's enrollment of 248 is below the median of 382 across 106 interventional studies indexed under Contraception Behavior.

Browse Contraception Behavior studies →

Lead sponsor

Mathematica Policy Research, Inc. is the lead sponsor of 49 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 19 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be expectant or parenting

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
248 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

    No active treatment for control group. Control group has access to "business as usual" services in community.

Interventions

  • BehavioralHealthy Families, Healthy Futures

    Home visiting program for pregnant and parenting teens

06

What researchers measure

Primary outcomes

  1. Exposure to information on relationships, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"

    Binary variable: equal to one if respondent reported attending a class or session (individual or group) about relationships, dating, or marriage

    Time frame: 12 months

  2. Exposure to information on parenting, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"

    : 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

    Time frame: 12 months

  3. Exposure to information on child healthcare, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"

    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

    Time frame: 12 months

  4. Exposure to education related services, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"

    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

    Time frame: 12 months

  5. Exposure to career counseling or job training, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"

    Binary variable: equal to one if respondent reported participating in career counseling or job training

    Time frame: 12 months

  6. Exposure to information about methods of birth control, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"

    Binary variable: equal to one if respondent reported receiving information from doctor, nurse, home visitor, or clinic regarding methods of birth control

    Time frame: 12 months

  7. Knowledge of condoms

    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"

    Time frame: 12 months

  8. Knowledge of birth control pills

    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"

    Time frame: 12 months

  9. Knowledge of IUDs

    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"

    Time frame: 12 months

  10. Knowledge of other hormonal and LARC methods

    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.

    Time frame: 12 months

  11. Use of a LARC

    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"

    Time frame: 12 months

  12. Unprotected sex

    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"

    Time frame: 12 months

  13. Intention to space births

    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"

    Time frame: 12 months

  14. Mother's engagement in play with child

    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"

    Time frame: 12 months

  15. Father's engagement with child

    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"

    Time frame: 12 months

  16. Quality of co-parenting relationship

    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"

    Time frame: 12 months

  17. Financial support from father

    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"

    Time frame: 12 months

  18. Capacity for self-sufficiency- Goals, plans, problem solving

    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"

    Time frame: 12 months

  19. Number of well visits

    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"

    Time frame: 12 months

  20. Health insurance for child

    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"

    Time frame: 12 months

07

Study locations

1 site
  • Houston Department of Health; participants' homes
    Houston, Texas 77002, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2015 to primary completion in Sep 2016, 15 months.

Of 64 non-industry interventional studies with no phase under Contraception Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's 15 months is below that.

Counting every sponsor, half of 64 studies reached it within 20 months; a quarter within 13 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2018
First posted
Feb 5, 2018
StartActual
Jun 2015
Primary completionActual
Sep 2016
CompletionEst.
Dec 2018
Last update
Aug 24, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03419728
Lead sponsor
Mathematica Policy Research, Inc.
Collaborators
The Office of Adolescent Health, HHS, Decision Information Resources, Inc.
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Jun 2015
Primary completion
Sep 2016
Completion
Dec 2018 (estimated)
Last update
Aug 24, 2018

Study contacts

John Deke
principal investigator · Mathematica Policy Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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