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Pregnancy PreventionNCT03366636

Project Legacy Impact Evaluation Study

A study testing Project Legacy in people with Pregnancy Prevention and Sexual Behavior, run by Children's Hospital Los Angeles at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 19 yearsHealthy volunteers can take part
What is being tested?
Project Legacy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
571 participants
Where
12 sitesUnited States
Study dates
30 Oct 2017to 30 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Five Keys

    Boyle Heights, California, 90033

  • Youth Program

    Long Beach, California, 90712

  • Century Villages at Cabrillo

    Long Beach, California, 90810

  • Da Vinci Rise High

    Los Angeles, California, 90011

  • LA CAUSA Youth Build

    Los Angeles, California, 90022

  • Covenant House

    Los Angeles, California, 90027

  • Los Angeles LGBT Center

    Los Angeles, California, 90038

  • YMCA of San Diego County

    Oceanside, California, 92054

  • San Diego Central Library

    San Diego, California, 92101

  • San Diego Youth Services

    San Diego, California, 92110

  • Monarch School

    San Diego, California, 92113

  • Safe Place for Youth

    Venice, California, 90291

Other trials in United States

About this 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.

Read the 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.

Being tested
Project Legacy
Keywords
Pregnancy Prevention, Adolescents, STIs/STDs, Self-sufficiency
Medical subject headings
Sexual Behavior, Contraception Behavior, Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Project LegacyBehavioural

    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
Study groups in NCT03366636
Study groupRoleWhat they receive
ControlNo interventionThe 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 LegacyExperimentalThe experimental/intervention arm will receive the Project Legacy intervention
Receives: Behavioral: Project Legacy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed at baseline and 11 months post-baseline

  2. 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.

    Measured: Assessed at baseline and 11 months post-baseline

Secondary outcomes (10)

  1. Sexual initiation / activity (vaginal)

    Ever engaged in vaginal sex.

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

  2. Current birth control use (vaginal sex)

    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.

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

  3. Current condom use (vaginal sex)

    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

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

  4. Proportion of youth who have vaginal intercourse without the consistent use of contraception

    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".

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

  5. Current contraception use (among females)

    Current contraception use is defined as the use of one or more methods of effective contraception in the past 3 months

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

  6. Current marijuana or alcohol use

    Current marijuana or alcohol use is defined as marijuana or alcohol use in the past 3 months

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

  7. Stable living environment at the time of the follow-up (current)

    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.

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

  8. Employment experience (current)

    Employed part or full-time since baseline; certificate, post-high school or college completed;

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

  9. Engagement in job-readiness services

    Services defined as job preparedness skill-building, job internships, or educational services

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

  10. Social support (current)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2017
  2. Study start30 Oct 2017
  3. Primary completion30 Mar 2021
  4. Study completion30 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
571 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03366636
Sponsor's protocol ID
CHLA-17-00322
Status last verified
Dec 2023
First submitted
17 Nov 2017
Last updated
3 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10195802

  • 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.

    PubMed 22120422

  • 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.

    PubMed 12940468

  • 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.

    PubMed 23231333

  • 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.

    PubMed 2280326

  • 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.

    PubMed 21895358

  • 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.

    PubMed 12128042

  • 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

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

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

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

  • 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.

    PubMed 21194011

  • 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.

    PubMed 10557519

  • 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.

    PubMed 21477680

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

Questions about this trial

What is this clinical trial studying?

A study testing Project Legacy in people with Pregnancy Prevention and Sexual Behavior, run by Children's Hospital Los Angeles at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03366636, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.

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