Project Legacy Impact Evaluation Study

Study Overview
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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.

Official Title
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Project Legacy Impact Evaluation Study

Conditions
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Pregnancy, Sexual Behavior, Contraception Behavior, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Project Legacy


Participation Criteria
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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: There are no exclusion criteria. Youth who are not initially eligible based on the criteria above may be enrolled at a later date if their eligibility changes.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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.). | |
| Experimental: Project Legacy<br>The experimental/intervention arm will receive the Project Legacy intervention | Behavioral: Project Legacy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Four questions were adapted from the Adolescent Sexual Activity Index (ASAI) (Hansen, Paskett, & Carter, 1999) to measure this outcome: In the past 3 months, how many times did you have vaginal sex? In the past 3 months, when you had vaginal sex, how many times did you and your partner(s) have sex and NOT use a condom? In the past 3 months, how many times did you have anal sex? In the past 3 months, when you had anal sex, how many times did you and your partner(s) have sex and NOT use a condom? | Assessed at baseline and 11 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual initiation / activity (vaginal) | Ever engaged in vaginal sex. | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Current sexual activity (vaginal) | Current vaginal sexual activity is defined as having had vaginal sex (when a penis it put in a vagina) in the past 3 months. This is measured using the question, In the past 3 months, did you have vaginal sex? | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| 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 | 
| 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 (Hansen, Paskett, & Carter, 1999). | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Current unprotected sex (vaginal and anal sex) | Current unprotected vaginal and anal sex is defined as: the number of instances of vaginal and anal sex during which condoms were not used in the past 3 months. Two questions were adapted from the Adolescent Sexual Activity Index (ASAI) (Hansen, Paskett, & Carter, 1999) to measure this outcome: In the past 3 months, when you had vaginal sex, how many times did you and your partner(s) have sex and NOT use a condom? In the past 3 months, when you had anal sex, how many times did you and your partner(s) have sex and NOT use a condom? | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Current sexual activity (oral) | Current sexual activity (oral) is measured using the question, In the past 3 months, how many times did you have oral sex? Oral sex is when a mouth is put on a penis or vagina. This question is from the Administration for Children and Families core measures. | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Pregnancy | Ever been pregnant/caused pregnancy | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Adult communication (current) | Communication with caring adult; This outcome is measured using a question from the Administration on Children and Families core measures: In the past three months, how often would you say you talked about things that really matter with a parent or adults? | 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 | This outcome is defined as using contraception for less than 80% of instances of vaginal sex in the past 3 months. Two questions were adapted from the Adolescent Sexual Activity Index (ASAI) (Hansen, Paskett, & Carter, 1999) to measure this outcome: 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 | 
| Proportion of youth who have vaginal or anal sexual intercourse without the consistent use of condoms | This outcome is defined as the proportion of youth who had any vaginal or anal sex without the use of a condom in the past 3 months. Four questions were adapted from the Adolescent Sexual Activity Index (ASAI) (Hansen, Paskett, & Carter, 1999) to measure this outcome: In the past 3 months, how many times did you have vaginal sex? In the past 3 months, when you had vaginal sex, how many times did you and your partner(s) have sex and NOT use a condom? In the past 3 months, how many times did you have anal sex? In the past 3 months, when you had anal sex, how many times did you and your partner(s) have sex and NOT use a condom? | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| 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 (Trussell, 2011). | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Number of recent unprotected vaginal intercourse acts | This outcome measure is defined as: the number of instances of vaginal intercourse during which a condom was not used in the past 3 months. It is measured using a question adapted from the Adolescent Sexual Activity Index (ASAI) (Hansen, Paskett, & Carter, 1999): In the past 3 months, when you had vaginal sex, how many times did you and your partner(s) have sex and NOT use a condom? | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Number of recent unprotected anal intercourse acts | This outcome measure is defined as: the number of acts of anal intercourse in which a condom was not used in the past 3 months. It is measured using the question, In the past 3 months, when you had anal sex, how many times did you and your partner(s) have sex and NOT use a condom? | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Current hard drug use | Current hard drug use is defined as cocaine, heroin, and/or methamphetamine use in the past 3 months. It is measured using questions from the CDC's Youth Risk Behavior Surveillance (YRBS) questionnaire that have been used with homeless adolescents (Rice, Milburn, & Monro, 2011). | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Current alcohol use | Current alcohol use is defined as alcohol use in the past 3 months. It is measured using questions from the CDC's Youth Risk Behavior Surveillance (YRBS) questionnaire that have been used with homeless adolescents (Rice, Milburn, & Monro, 2011). | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Current marijuana use | Current marijuana use is defined as marijuana use in the past 3 months and is measured using questions from the CDC's Youth Risk Behavior Surveillance (YRBS) questionnaire. | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| 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 | 
| Educational progress | Defined as increment from baseline standing with respect to high school grade, GED certificate; post-high school or college completed | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| 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 | 
| 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 | 
| Social support (current) | Social support is measured using The Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, 1988). The scale has 12 items and 3 subscales (family, friends, and significant other) with 4 items each. 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. The total score is calculated by averaging the 12 items on the scale, and subscales are calculated by averaging the 4 items in each subscale. | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Future orientation (current) | Future Orientation is the extent to which an individual thinks about and acts upon the future. This study assess future orientation using a scale developed by Chen & Vazsonyi (2011). The scale contains 6 items, but based on feedback from piloting, 2 items were omitted (You will be killed by age 21 and You will get HIV or AIDS) leaving 4 items in the final scale. The scale is calculated by averaging all items and ranges from 1 to 5, with higher scores indicating greater future orientation. | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Work-hope scale (current) | Work-hope is a positive motivation state that is directed at work and work-related goals and is composed of the presence of work-related goals and both the agency and pathways for achieving those goals (Juntunen & Wettersten, 2006). The Work-Hope Scale (Juntunen & Wettersten, 2006) measures work-hope and consists of 28 items. Eight items from the scale are used in this study, which are averaged to get a total score ranging from 8 to 56, with higher scores indicating greater work-hope. | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Self-determinism/Personal Growth Initiative (current) | The Personal Growth Initiative (PGI) Scale (Robitschek, 1998) is a 9-item scale that assesses an individual's active, intentional engagement in the process of personal growth. Items are summed to obtain a total PGI score, which ranges from 9 to 54, with higher scores indicating greater PGI. | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Balance of possible selves (current) | Possible selves are the hypothetical images (the self one would like to attain, the self one would like to avoaid) critical for motivating action (Oyserman & Bybee, 2002). Open-ended questions from Oyserman, Bybee, Terry, and Hart-Johnson (2004) are used to assess number of possible selves, number of achievement strategies, and self-regulation scores. Responses are content-coded and then scored with higher scores indicating greater self-regulation. | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 
| Prevention and promotion orientation (Regulatory Focus) (current) | Regulatory Focus refers to the theory that people are motivated by two different types of regulation goals: promotion (eager pursuit of gains or successes) and prevention (striving to avoid negative outcomes) (Higgins, 1997). This study uses two scales to assess regulatory focus: (1) Strauman (2006) and (2) Lockwood, Jordan, and Kunda (2002). The Strauman (2006) scale has 12 items, of which 8 are used in this study. There are two subscales, prevention and promotion, which are scored by averaging responses and range from 1 to 5 with higher scores indicating a greater prevention or promotion orientation. The Lockwood, Jordan, and Kunda (2002) scale has 18 items, of which 10 are used in this study. There are two subscales, prevention and promotion, which are scored by adding responses and range from 5 to 54. The total score is calculated by subtracting the prevention score from the promotion score, with a higher score indicating a stronger promotion orientation. | Assessed at baseline, 5 months post-baseline, and 11 months post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Adolescents, STIs/STDs, Self-sufficiency