Clinical trial NCT04181034: Impacts of the Positive Youth Development Program for Expectant and Parenting Teens in California
Official title: Impacts of the Positive Youth Development Program for Expectant and Parenting Teens in California
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teen Pregnancy Prevention
Keywords: Teen pregnancy prevention
Home visiting
Positive youth development
Adolescent Family Life Program Positive Youth Development
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
Collaborators: name: Office of Population Affairs
name: California Department of Public Health, MCAH
First posted: 2019-11-29
Enrollment: 1330
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
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 is conducting an impact study of California Department of Public Health, Center for Family Health, Maternal, Child and Adolescent Health's (MCAH) Adolescent Family Life Program Positive Youth Development (PYD) program for a Federal Evaluation of Programs for Expectant and Parenting Youth (PEPY). The impact study will be designed to address the impact of PYD, compared to the business-as-usual condition, AFLP, in delaying repeat pregnancies, completing high school, improving health of the parent and child, and improving linkages and networks of support for expectant and parenting teens.

Detailed description: The Adolescent Family Life Program (AFLP) has been used by MCAH for more than 3 decades. The program was recently enhanced with a positive youth development component, referred to as Adolescent Family Life Program Positive Youth Development (PYD) program. The enhanced program is a shorter, more intensive program that requires case managers to use motivational interviewing to guide participating youth through a prescribed set of activities designed to set achievable goals for life planning and building self-sufficiency. A random assignment design will be used to assess the program's impact on exposure to program content and short term outcomes.

The evaluation includes two sub-studies, each with a distinct design. In the first sub-study, individuals were randomly assigned as part of the enrollment process within two provider sites to receive either PYD or AFLP. These two provider sites could support individual random assignment because they had enough case managers and clients to support both study conditions (PYD and AFLP). In the second sub-study, 13 provider sites, each with a smaller number of case managers and clients, were randomly assigned to PYD or AFLP. In this second sub-study, participants enrolled after sites were randomly assigned. Potential study participants were recruited between December 2014 and January 2017, and were considered eligible for participation if they were they (1) were interested in the program, (2) were pregnant or parenting, (3) had not been served at the site in the prior six months, (4) spoke either English or Spanish, (5) were between ages 14 and 18, and (6) were not enrolled in Nurse Family Partnerships.

For sub-study 1, potential participants who were eligible were randomly assigned to (1) a treatment group that was eligible for PYD or (2) a control group that received AFLP. Random assignment was conducted within two blocks determined by random assignment site and whether study participants were pregnant at the time of random assignment or were parenting at the time of random assignment. After random assignment, the study enrollment manager assigned the young mother to a case manager delivering the program to which she was assigned. The assigned case manager then tried to locate and conduct a first visit with each randomized youth mother, but not all could be found. For most who were found and visited, case managers were instructed to follow a script that described the program in general terms (without differentiating between AFLP and PYD) and the study in detail. The script did not reveal the group to which the young mother was assigned. As part of the scripted interaction, case managers sought study consent from young mothers to participate in the study data collection.

For sub-study 2, provider sites were first randomized to either the PYD or AFLP. Young mothers were then referred to sites in the same manner as in the first sub-study, went through the same initial eligibility screening process. Eligible mothers were assigned a case manager. The assigned case manager then tried to locate and conduct a first visit with each eligible youth mother, but not all could be found. For most who were found and visited, case managers were instructed to follow a script that described the program in general terms (without differentiating between AFLP and PYD) and the study in detail. The script did not reveal the group to which the young mother was assigned. As part of the scripted interaction, case managers sought study consent from young mothers to participate in the study data collection.

The study draws on data from LodeStar, MCAH's administrative records on service receipt, a baseline survey administered after enrollment into the study, a follow-up survey administered approximately 12 months after enrollment and a follow up survey administered approximately 24 months after enrollment.

Eligibility criteria: Inclusion Criteria:

* must be expectant or parenting

Exclusion Criteria:

* Served by enrollment site in six months prior to random assignment
* Enrolled in Nurse Family Partnership program at time of random assignment
* younger than 14 years of age or older than 18 years of age
* Primary language is neither English nor Spanish

Primary outcomes:
measure: Frequency of case manager visits, as measured by administrative data
timeFrame: 12 month
measure: Frequency of case manager visits, as measured by administrative data
timeFrame: 24 month
measure: Early exit from program, as measured by administrative data
timeFrame: 12 months
measure: Exposure to information on relationships in year 1, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Exposure to information on relationships in year 2, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to information on relationships cumulative measure, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California" and the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to information on parenting in year 1, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Exposure to information on family planning in year 1, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Exposure to information on parenting in year 2, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to information on family planning in year 2, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to information on parenting cumulative measure, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California" and "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to information on family planning cumulative measure, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California" and "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to information on child's access to healthcare in year 1, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Exposure to information on child's access to healthcare in year 2, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to information on child's access to healthcare cumulative measure, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California" and "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to education related services in year 1, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Exposure to education related services in year 2, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to education related services cumulative measure, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California" and "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to workforce assistance related services year 1, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Exposure to workforce assistance related services year 2, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to workforce assistance related services cumulative measure, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California" and "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to information on access to healthcare in year 1, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Exposure to information on access to healthcare in year 2, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Exposure to information on access to healthcare cumulative measure, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California" and "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Respondent feelings about themselves, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Respondent feelings about themselves, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Respondent feelings about personal goals, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Respondent feelings about personal goals, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Linkages and referrals year 1, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Linkages and referrals year 2, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Linkages and referrals cumulative measure, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California" and "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Increased access to and strengthened relationship with a trusted adult year 1
timeFrame: 12 months
measure: Increased access to and strengthened relationship with a trusted adult year 2
timeFrame: 24 months
measure: Unprotected sex, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Unprotected sex, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Use of birth control, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Use of birth control, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Knowledge of condoms, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Knowledge of condoms, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Knowledge of birth control pills, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Knowledge of birth control pills, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Knowledge of Intrauterine devices (IUDs), as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Knowledge of Intrauterine devices (IUDs), as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Knowledge of other hormonal and long-acting reversible contraception (LARC) methods, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Knowledge of other hormonal and long-acting reversible contraception (LARC) methods, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Depressive symptoms, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Depressive symptoms, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Received postpartum medical checkup, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Health insurance for respondent, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Health insurance for respondent, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Continued high school attachment, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Continued high school attachment, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Subsequent pregnancy, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"and "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Sexually transmitted disease, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"and "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
measure: Positive attitudes towards healthy relationships, as measured by the "Positive Adolescent Futures Final 12 Month Follow-up Survey - California"
timeFrame: 12 months
measure: Positive attitudes towards healthy relationships, as measured by the "Positive Adolescent Futures Final 24 Month Follow-up Survey - California"
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goleta
country: United States
facility: Community Action Partnership of Santa Barbara County
state: California
city: Hayward
country: United States
facility: Tiburcio Vasquez Health Center
state: California
city: Kelseyville
country: United States
facility: Lake Family Resource Center
state: California
city: Los Angeles
country: United States
facility: AltaMed Health Services
state: California
city: Mission Hills
country: United States
facility: El Nido Family Centers
state: California
city: Modesto
country: United States
facility: Stanislaus County Health Services
state: California
city: Roseville
country: United States
facility: Placer County Health and Human Services
state: California
city: Sacramento
country: United States
facility: Sutter Health Teen Programs
state: California
city: San Diego
country: United States
facility: 1. San Diego Adolescent Pregnancy and Parenting Program (San Diego Unified School District)
state: California
city: San Francisco
country: United States
facility: Felton Institute Family Service Agency of San Francisco
state: California
city: San Jose
country: United States
facility: Planned Parenthood Mar Monte
state: California
city: San Luis Obispo
country: United States
facility: Community Action Partnership of San Luis Obispo
state: California
city: Santa Rosa
country: United States
facility: Sonoma County Health Department
state: California
Study officials:
affiliation: Mathematica Policy Research
name: Susan Zief, PhD
role: PRINCIPAL_INVESTIGATOR
References: