Project Legacy Impact Evaluation Study

NCT03366636 | Completed

• 1 other identifier: CHLA-17-00322
• Study Type: interventional
• Target: 571
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Pregnancy Prevention; Sexual Behavior; Contraception Behavior; Sexually Transmitted Diseases

Keywords

Pregnancy Prevention; Adolescents; STIs/STDs; Self-sufficiency

Outcome Measures

Primary Outcomes (2)

• Change from baseline lack of consistent current use (<80%) of contraception (including condoms) at 11 months

  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

  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 Outcomes (10)

• Sexual initiation / activity (vaginal)

  Assessed at baseline, 5 months post-baseline, and 11 months post-baseline

• Current birth control use (vaginal sex)

  Assessed at baseline, 5 months post-baseline, and 11 months post-baseline

• Current condom use (vaginal sex)

  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

  Assessed at baseline, 5 months post-baseline, and 11 months post-baseline

• Current contraception use (among females)

  Assessed at baseline, 5 months post-baseline, and 11 months post-baseline

Study Arms (2)

Control

NO INTERVENTION

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.).

Project Legacy

EXPERIMENTAL

The experimental/intervention arm will receive the Project Legacy intervention

Behavioral: Project Legacy

Interventions

Project Legacy BEHAVIORAL

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

Project Legacy

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Served or identified on outreach by one of our partner homeless youth serving agencies in Los Angeles or San Diego
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• ETR Associates: collaborator

Study Sites (12)

Five Keys

Boyle Heights, California, 90033, United States

Location

Youth Program

Long Beach, California, 90712, United States

Location

Century Villages at Cabrillo

Long Beach, California, 90810, United States

Location

Da Vinci Rise High

Los Angeles, California, 90011, United States

Location

LA CAUSA Youth Build

Los Angeles, California, 90022, United States

Location

Covenant House

Los Angeles, California, 90027, United States

Location

Los Angeles LGBT Center

Los Angeles, California, 90038, United States

Location

YMCA of San Diego County

Oceanside, California, 92054, United States

Location

San Diego Central Library

San Diego, California, 92101, United States

Location

San Diego Youth Services

San Diego, California, 92110, United States

Location

Monarch School

San Diego, California, 92113, United States

Location

Safe Place for Youth

Venice, California, 90291, United States

Location

Related Publications (16)

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  PMID: 22120422 BACKGROUND

• Rotheram-Borus MJ, Song J, Gwadz M, Lee M, Van Rossem R, Koopman C. Reductions in HIV risk among runaway youth. Prev Sci. 2003 Sep;4(3):173-87. doi: 10.1023/a:1024697706033.

  PMID: 12940468 BACKGROUND

• Tucker JS, Sussell J, Golinelli D, Zhou A, Kennedy DP, Wenzel SL. Understanding pregnancy-related attitudes and behaviors: a mixed-methods study of homeless youth. Perspect Sex Reprod Health. 2012 Dec;44(4):252-61. doi: 10.1363/4425212. Epub 2012 Nov 13.

  PMID: 23231333 BACKGROUND

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  PMID: 2280326 BACKGROUND

• Chen P, Vazsonyi AT. Future orientation, impulsivity, and problem behaviors: a longitudinal moderation model. Dev Psychol. 2011 Nov;47(6):1633-45. doi: 10.1037/a0025327. Epub 2011 Sep 5.

  PMID: 21895358 BACKGROUND

• Oyserman D, Terry K, Bybee D. A possible selves intervention to enhance school involvement. J Adolesc. 2002 Jun;25(3):313-26. doi: 10.1006/jado.2002.0474.

  PMID: 12128042 BACKGROUND

• Thompson, S., Pollio, D., Constantine, J., Reid, D., Nebbitt, V. Short-term outcomes of youth receiving runaway and homeless shelter services. Research on Social Work Practice. 2002 Sept; 12: 589-603

  BACKGROUND

• Juntunen, C.L., & Wettersten, K. Work hope: Development and initial validation of a measure. Journal of Counseling Psychology. 2006; 53(1): 94-106.

  BACKGROUND

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  BACKGROUND

• Strauman, T.J. (2006). Adolescent Regulatory Focus Questionnaire. Unpublished questionnaire, Duke University, Durham, NC.

  BACKGROUND

• Rice E, Milburn NG, Monro W. Social networking technology, social network composition, and reductions in substance use among homeless adolescents. Prev Sci. 2011 Mar;12(1):80-8. doi: 10.1007/s11121-010-0191-4.

  PMID: 21194011 BACKGROUND

• Hansen WB, Paskett ED, Carter LJ. The Adolescent Sexual Activity Index (ASAI): a standardized strategy for measuring interpersonal heterosexual behaviors among youth. Health Educ Res. 1999 Aug;14(4):485-90. doi: 10.1093/her/14.4.485.

  PMID: 10557519 BACKGROUND

• Trussell J. Contraceptive failure in the United States. Contraception. 2011 May;83(5):397-404. doi: 10.1016/j.contraception.2011.01.021. Epub 2011 Mar 12.

  PMID: 21477680 BACKGROUND

• Oyserman D, Bybee D, Terry K, & Hart-Johnson T. Possible selves as roadmaps. Journal of Research in Personality 38: 130-149, 2004.

  BACKGROUND

• Higgins ET. Beyond pleasure and pain. Am Psychol. 1997 Dec;52(12):1280-300. doi: 10.1037//0003-066x.52.12.1280.

  PMID: 9414606 BACKGROUND

MeSH Terms

Conditions

Sexual Behavior; Contraception Behavior; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Behavior; Reproductive Behavior; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leslie F Clark, PhD, MPH

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 8, 2017
• Study Start: October 30, 2017
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)