Project Legacy Impact Evaluation Study

NCT ID: NCT03366636

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

571 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2021-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Prevention Sexual Behavior Contraception Behavior Sexually Transmitted Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.).

Group Type NO_INTERVENTION

No interventions assigned to this group

Project Legacy

The experimental/intervention arm will receive the Project Legacy intervention

Group Type EXPERIMENTAL

Project Legacy

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ETR Associates

OTHER

Sponsor Role collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Mona Desai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leslie F Clark, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Five Keys

Boyle Heights, California, United States

Site Status

Youth Program

Long Beach, California, United States

Site Status

Century Villages at Cabrillo

Long Beach, California, United States

Site Status

Da Vinci Rise High

Los Angeles, California, United States

Site Status

LA CAUSA Youth Build

Los Angeles, California, United States

Site Status

Covenant House

Los Angeles, California, United States

Site Status

Los Angeles LGBT Center

Los Angeles, California, United States

Site Status

YMCA of San Diego County

Oceanside, California, United States

Site Status

San Diego Central Library

San Diego, California, United States

Site Status

San Diego Youth Services

San Diego, California, United States

Site Status

Monarch School

San Diego, California, United States

Site Status

Safe Place for Youth

Venice, California, United States

Site Status

Countries

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United States

References

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De Rosa CJ, Montgomery SB, Kipke MD, Iverson E, Ma JL, Unger JB. Service utilization among homeless and runaway youth in Los Angeles, California: rates and reasons. J Adolesc Health. 1999 Mar;24(3):190-200. doi: 10.1016/s1054-139x(98)00081-0.

Reference Type BACKGROUND
PMID: 10195802 (View on PubMed)

Edidin JP, Ganim Z, Hunter SJ, Karnik NS. The mental and physical health of homeless youth: a literature review. Child Psychiatry Hum Dev. 2012 Jun;43(3):354-75. doi: 10.1007/s10578-011-0270-1.

Reference Type BACKGROUND
PMID: 22120422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12940468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23231333 (View on PubMed)

Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.

Reference Type BACKGROUND
PMID: 2280326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21895358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12128042 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Robitschek, C. Personal growth initiative: The construct and its measure. Measurement & Evaluation in Counseling & Development: American Counseling Association. 1998; 30(4): 183-198.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 21194011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10557519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21477680 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND
PMID: 9414606 (View on PubMed)

Other Identifiers

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CHLA-17-00322

Identifier Type: -

Identifier Source: org_study_id

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