Federal Evaluation of Selected Programs for Expectant and Parenting Youth

Contraceptive Usage Clinical Trial

— PEPY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03419728
• Other study ID #: 50023
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Mathematica Policy Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: December 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Usage
• Teen Pregnancy Prevention

Intervention

Behavioral:
• Healthy Families, Healthy Futures
Home visiting program for pregnant and parenting teens

Locations

Country	Name	City	State
United States	Houston Department of Health; participants' homes	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Mathematica Policy Research, Inc.	Decision Information Resources, Inc., The Office of Adolescent Health, HHS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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