INTERVENTIONALCOMPLETEDNCT03366636

Project Legacy Impact Evaluation Study

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2024-01-03

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: NA
Enrollment: 571 (ACTUAL)
Start date: 2017-10-30
Sponsor: Children's Hospital Los Angeles
Design: RANDOMIZED · PARALLEL · PREVENTION
Locations: 12
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

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

Eligibility

Population and criteria

Sex: ALL
Minimum age: 14 Years
Maximum age: 19 Years
Healthy volunteers: Accepted

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

primary outcomes

primary measures

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.

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.

secondary outcomes