NCT03419728

Brief 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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

January 9, 2018

Last Update Submit

August 23, 2018

Conditions

Keywords

Teen pregnancy preventionLong-acting reversible contraception (LARCs)Healthy Families Healthy FuturesHome visiting

Outcome Measures

Primary Outcomes (20)

  • 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

    12 months

  • 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

    12 months

  • 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

    12 months

  • 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

    12 months

  • 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

    12 months

  • 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

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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.

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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"

    12 months

  • 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"

    12 months

Study Arms (2)

Healthy Families, Healthy Futures

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Home visiting program for pregnant and parenting teens

Healthy Families, Healthy Futures

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must be expectant or parenting

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Department of Health; participants' homes

Houston, Texas, 77002, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • John Deke

    Mathematica Policy Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2018

First Posted

February 5, 2018

Study Start

June 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2018

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations