Project Legacy Impact Evaluation Study

December 27, 2023 updated by: Mona Desai, Children's Hospital Los Angeles
This study will design and rigorously evaluate the efficacy of Project Legacy, a five week positive youth development intervention to decrease sexual risk for unintended pregnancies and STIs among youth experiencing homelessness or at risk of homelessness aged 14-19. This randomized control trial will compare Project Legacy to a usual services control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study uses a multi-site randomized group trial (RGT) cohort design to evaluate the Project Legacy intervention curriculum for reducing sexual risk behaviors among homeless youth age 14-19. CHLA project staff will work with 6 homeless youth serving sites in Southern California (Los Angeles, San Diego) to recruit 600 youth. Randomization to the intervention or control condition will occur at the group level and will be stratified by site. Field staff will survey all eligible homeless youth who provide consent to participate in the study at baseline (before randomization and implementation) and at 3 and 9 months post intervention (5-5.5 and 11-11.5 months post-baseline). The program group will receive an additional intervention-based survey immediately upon completion of the program.

Youth in the control condition will receive the normal standard of care provided at the recruitment sites. Services available as standard of care at the recruitment sites include: medical care; mental health services; substance abuse services; educational, career, and vocational services. Intervention participants will not be excluded from receiving these services as well. Surveys will capture mental and physical health care service utilization and services to reduce substance use across both groups. The study team will monitor HIV and pregnancy prevention programming and other similar goal-planning/decision-making interventions offered to homeless youth in the study areas during the program implementation and follow-up period via interviews with site staff. The study team will include selected program exposure items on the follow up surveys to assess youth's self-reported exposure to similar goal-planning/decision-making and sexual health (pregnancy prevention and STI/HIV) education.

Study Type

Interventional

Enrollment (Actual)

571

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Boyle Heights, California, United States, 90033
        • Five Keys
      • Long Beach, California, United States, 90712
        • Youth Program
      • Long Beach, California, United States, 90810
        • Century Villages at Cabrillo
      • Los Angeles, California, United States, 90011
        • Da Vinci Rise High
      • Los Angeles, California, United States, 90022
        • LA CAUSA Youth Build
      • Los Angeles, California, United States, 90027
        • Covenant House
      • Los Angeles, California, United States, 90038
        • Los Angeles LGBT Center
      • Oceanside, California, United States, 92054
        • YMCA of San Diego County
      • San Diego, California, United States, 92101
        • San Diego Central Library
      • San Diego, California, United States, 92110
        • San Diego Youth Services
      • San Diego, California, United States, 92113
        • Monarch School
      • Venice, California, United States, 90291
        • Safe Place for Youth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Served or identified on outreach by one of our partner homeless youth serving agencies in Los Angeles or San Diego
  • 14-19 years of age
  • English-language speaker (able to complete consent and survey in English)
  • not currently pregnant
  • no immediate travel plans (are planning on being in the area for the length of the intervention - 8 weeks).

Exclusion Criteria:

  • Outside of age range
  • Currently pregnant
  • Not planning to be in the area for the length of the intervention
  • Previously enrolled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The control/comparison group will be receiving only their usual services which are offered at the agencies they frequent, including mental health services, case management, job training, educational services, and, in specific venue contexts, may receive HIV risk reduction or other "sex education" interventions such as Street Smart. These same services are also open to the intervention group. Usage of these services varies by site (residential vs drop-in; city (San Diego vs Los Angeles) and type of service (case management, mental health, health care, etc.).
Experimental: Project Legacy
The experimental/intervention arm will receive the Project Legacy intervention
Behavioral: Project Legacy

Project Legacy - Project Legacy is a 5-week, twice a week, 10 sessions small group intervention that encourages homeless and at-risk of homeless youth ages 14-19 to imagine a positive future and discuss how current risk behaviors can be a barrier to a successful adulthood. The program includes thinking about the future, the importance of positive social supports, short and long-term goal planning, and decision making. The program also includes life skills building, addressing past and current risk behaviors, linking to resources and navigating service systems, information on contraception and condoms, a healthy life plan and self-sufficiency. The 5 content core elements are the following:

  • 1. Thinking about the future
  • 2. Present actions to achieve future success
  • 3. Safeguarding one's future
  • 4. Creating a Healthy Life Plan
  • 5. Navigating service systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline lack of consistent current use (<80%) of contraception (including condoms) at 11 months
Time Frame: Assessed at baseline and 11 months post-baseline
Current use of contraception (including condoms) is defined as using contraception at >80% of instances of vaginal intercourse in the past 3 months.
Assessed at baseline and 11 months post-baseline
Change from baseline in current vaginal and anal sex without condom at 11 months
Time Frame: Assessed at baseline and 11 months post-baseline
This outcome measure is defined as the proportion of instances of vaginal and anal sex without a condom in the past 3 months.
Assessed at baseline and 11 months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual initiation / activity (vaginal)
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Ever engaged in vaginal sex.
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current birth control use (vaginal sex)
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current birth control use is defined as the number of instances of vaginal sex during which contraception was used (including condoms) in the past 3 months.
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Stable living environment at the time of the follow-up (current)
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Stable living defined as living in a parents', relatives' or foster parents' home; a group home or residential facility or a tenant of an apartment.
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Employment experience (current)
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Employed part or full-time since baseline; certificate, post-high school or college completed;
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Engagement in job-readiness services
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Services defined as job preparedness skill-building, job internships, or educational services
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current condom use (vaginal sex)
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current condom use for vaginal sex is defined as: the number of instances of vaginal sex during which condoms were used in the past 3 months
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Proportion of youth who have vaginal intercourse without the consistent use of contraception
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline

This outcome is defined as using contraception for less than 80% of instances of vaginal sex in the past 3 months.

  1. "In the past 3 months, how many times did you have vaginal sex?"
  2. "When you had vaginal sex in the past 3 months, how many times did you and your partner(s) have sex and NOT use any type of contraception (in other words, EITHER a condom OR other method of birth control)? By birth control, we mean using condom, birth control pills, the shot, the patch, the ring, IUD, or implant".
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current contraception use (among females)
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current contraception use is defined as the use of one or more methods of effective contraception in the past 3 months
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current marijuana or alcohol use
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Current marijuana or alcohol use is defined as marijuana or alcohol use in the past 3 months
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Social support (current)
Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Social support is measured using The Multidimensional Scale of Perceived Social Support. Total scores range from 7 to 84 and each subscale score ranges from 4 to 28, with a higher score indicating greater social support. which are averaged together to get the total score.
Assessed at baseline, 5 months post-baseline, and 11 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Los Angeles

Collaborators

ETR Associates

Investigators

  • Principal Investigator: Leslie F Clark, PhD, MPH, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHLA-17-00322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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