NCT04795999

Brief Summary

WestEd and its partners Urban Strategies, the Los Angeles County Probation Department, Boys Republic, California Family Life Center, and Eggleston Youth Centers Inc. are conducting a quasi-experimental design to evaluate an innovative teen pregnancy prevention program, Project With, for incarcerated and other justice-involved youth in Southern California. Project With is a 12-lesson literary-based curriculum that utilizes group discussions of literary works and films to address personal relationships and sexual health topics. This study involves youth (age 15-19) at high risk for involvement in risky sexual behaviors, including teen pregnancy. The intervention shows potential to promote optimal health and reduce teen pregnancy and sexually transmitted infections (STIs) among incarcerated and other justice-involved youth, based on a previous formative evaluation of the intervention in 2018-2020. The purpose of this study is to test the curriculum on a population of incarcerated and other justice-involved youth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
415

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.9 years

First QC Date

March 9, 2021

Last Update Submit

July 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Risky sexual behaviors

    The outcome will be assessed with three items that assess whether youth had sexual intercourse with multiple partners, sexual intercourse without a condom, and sexual intercourse without using any method of birth control in the past three months (Rotz et al., 2016).

    Six months after the baseline

Secondary Outcomes (5)

  • Ability to resist temptations and provocations

    Two and six months after the baseline

  • Planfulness

    Two and six months after the baseline

  • Acceptance of intimate partner violence

    Two and six months after the baseline

  • Self-efficacy to avoid risky sexual behavior

    Two and six months after the baseline

  • Intentions to engage in risky sexual behavior

    Two and six months after the baseline

Study Arms (2)

Project With program

EXPERIMENTAL

Project With is a 12-lesson literary-based curriculum, delivered by Youth Advocates to youth in juvenile justice facilities and group homes in Southern California either in person or virtually, under COVID-19 contingencies. Program schedule is determined by the facility. The goals of Project With are to promote optimal health and reduce teen pregnancy and sexually transmitted infections (STIs).

Behavioral: Project With

Treatment as usual

NO INTERVENTION

The counterfactual condition for the study is a business-as-usual condition.

Interventions

Project WithBEHAVIORAL

There are 12 lessons in Project With, typically delivered in six weekly sessions, with each session having two one-hour long lessons and a meal with facilitators in between the two lessons. Each lesson includes a discussion of selected literary works, including poetry, short stories, and excerpts from films and other videos. The curriculum is intended to be delivered to groups of 8-12 youth. In ideal program delivery, participants also share a meal with each other and with the Youth Advocate. Shared mealtimes create group cohesion and allow Youth Advocates to connect with participants on a personal level, building trust. At the end of the Project With curriculum, youth will partake in an offsite day excursion to Camp Eaton, a wooded camp outside of Los Angeles. At Camp Eaton, Youth Advocates will lead a Project With session, lunch, bonding activities and games, and an opportunity to engage in an outdoor activity.

Project With program

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 15-19
  • Residing in one of the Los Angeles County Probation Department camps or group homes within a partnered network
  • Have the cognitive ability to complete the baseline and follow-up surveys in English or Spanish
  • Need to be at the facilities for at least 8 weeks to complete the program

You may not qualify if:

  • Outside of age criteria
  • Not residing in one of the Los Angeles County Probation Department camps or group homes within a partnered network
  • Does not have the cognitive ability to complete the baseline and follow-up surveys in English or Spanish
  • Not remaining at the facilities for 8 weeks or more
  • Youth who participated in a previous evaluation wave as part of the treatment or comparison group cannot participate in the evaluation a second time (i.e., during a second wave)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urban Strategies

Alhambra, California, 91801, United States

Location

Study Officials

  • Jonathan Nakamoto, PhD

    WestEd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The treatment condition involves participation in a teen pregnancy prevention program, Project With. The comparison condition for the study is treatment as usual.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Associate

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

February 1, 2021

Primary Completion

December 31, 2023

Study Completion

July 15, 2024

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations