Clinical trial NCT03419728: Federal Evaluation of Selected Programs for Expectant and Parenting Youth
Official title: Understanding the Effectiveness of Healthy Families Healthy Futures in Houston, Texas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Teen Pregnancy Prevention
Contraceptive Usage
Keywords: Teen pregnancy prevention
Long-acting reversible contraception (LARCs)
Healthy Families Healthy Futures
Home visiting
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
Collaborators: name: The Office of Adolescent Health, HHS
name: Decision Information Resources, Inc.
First posted: 2018-02-05
Enrollment: 248
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exposure to information on relationships, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
timeFrame: 12 months
measure: Exposure to information on parenting, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
timeFrame: 12 months
measure: Exposure to information on child healthcare, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
timeFrame: 12 months
measure: Exposure to education related services, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
timeFrame: 12 months
measure: Exposure to career counseling or job training, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
timeFrame: 12 months
measure: Exposure to information about methods of birth control, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - Texas"
timeFrame: 12 months
measure: Knowledge of condoms
timeFrame: 12 months
measure: Knowledge of birth control pills
timeFrame: 12 months
measure: Knowledge of IUDs
timeFrame: 12 months
measure: Knowledge of other hormonal and LARC methods
timeFrame: 12 months
measure: Use of a LARC
timeFrame: 12 months
measure: Unprotected sex
timeFrame: 12 months
measure: Intention to space births
timeFrame: 12 months
measure: Mother's engagement in play with child
timeFrame: 12 months
measure: Father's engagement with child
timeFrame: 12 months
measure: Quality of co-parenting relationship
timeFrame: 12 months
measure: Financial support from father
timeFrame: 12 months
measure: Capacity for self-sufficiency- Goals, plans, problem solving
timeFrame: 12 months
measure: Number of well visits
timeFrame: 12 months
measure: Health insurance for child
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Department of Health; participants' homes
state: Texas
Study officials:
affiliation: Mathematica Policy Research
name: John Deke
role: PRINCIPAL_INVESTIGATOR
References: