Project Legacy Impact Evaluation Study

Sexually Transmitted Diseases Clinical Trial

Official title:

Project Legacy Impact Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366636
• Other study ID #: CHLA-17-00322
• Status: Completed
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: March 30, 2021

Study information

• Verified date: December 2023
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This randomized control trial will compare Project Legacy to a usual services control.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

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

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

Locations

Country	Name	City	State
United States	Five Keys	Boyle Heights	California
United States	Century Villages at Cabrillo	Long Beach	California
United States	Youth Program	Long Beach	California
United States	Covenant House	Los Angeles	California
United States	Da Vinci Rise High	Los Angeles	California
United States	LA CAUSA Youth Build	Los Angeles	California
United States	Los Angeles LGBT Center	Los Angeles	California
United States	YMCA of San Diego County	Oceanside	California
United States	Monarch School	San Diego	California
United States	San Diego Central Library	San Diego	California
United States	San Diego Youth Services	San Diego	California
United States	Safe Place for Youth	Venice	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	ETR Associates

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sexual initiation / activity (vaginal)	Ever engaged in vaginal sex.	Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Secondary	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.	Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Secondary	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	Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Secondary	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.; "In the past 3 months, how many times did you have vaginal sex?"; "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
Secondary	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	Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Secondary	Current marijuana or alcohol use	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
Secondary	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.	Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Secondary	Employment experience (current)	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
Secondary	Engagement in job-readiness services	Services defined as job preparedness skill-building, job internships, or educational services	Assessed at baseline, 5 months post-baseline, and 11 months post-baseline
Secondary	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.	Assessed at baseline, 5 months post-baseline, and 11 months post-baseline