Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Project Legacy Impact Evaluation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03366636
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
ETR Associates
Information provided by (Responsible Party):
Leslie Clark, University of Southern California

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE December 8, 2017
Last Update Posted Date January 29, 2019
Actual Study Start Date  ICMJE October 30, 2017
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • 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 ]
    Current use of contraception (including condoms) is defined as using contraception at >80% of instances of vaginal intercourse in the past 3 months.
  • Change from baseline in current vaginal and anal sex without condom at 11 months [ Time Frame: Assessed at baseline and 11 months post-baseline ]
    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:
    1. "In the past 3 months, how many times did you have vaginal sex?"
    2. "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?"
    3. "In the past 3 months, how many times did you have anal sex?"
    4. "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?"
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2017)
  • 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 ]
    Current use of contraception (including condoms) is defined as using contraception at <80% of instances of vaginal intercourse in the past 3 months.
  • Change from baseline in current vaginal and anal sex without condom at 11 months [ Time Frame: Assessed at baseline and 11 months post-baseline ]
    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:
    1. "In the past 3 months, how many times did you have vaginal sex?"
    2. "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?"
    3. "In the past 3 months, how many times did you have anal sex?"
    4. "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?"
Change History Complete list of historical versions of study NCT03366636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • Sexual initiation / activity (vaginal) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Ever engaged in vaginal sex.
  • Current sexual activity (vaginal) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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?"
  • Current birth control use (vaginal sex) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Current condom use (vaginal sex) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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).
  • Current unprotected sex (vaginal and anal sex) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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:
    1. "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?"
    2. "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?"
  • Current sexual activity (oral) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Pregnancy [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Ever been pregnant/caused pregnancy
  • Adult communication (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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?"
  • Proportion of youth who have vaginal intercourse without the consistent use of contraception [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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:
    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".
  • Proportion of youth who have vaginal or anal sexual intercourse without the consistent use of condoms [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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:
    1. "In the past 3 months, how many times did you have vaginal sex?"
    2. "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?"
    3. "In the past 3 months, how many times did you have anal sex?"
    4. "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?"
  • Current contraception use (among females) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Current contraception use is defined as the use of one or more methods of effective contraception in the past 3 months (Trussell, 2011).
  • Number of recent unprotected vaginal intercourse acts [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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?"
  • Number of recent unprotected anal intercourse acts [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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?"
  • Current hard drug use [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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).
  • Current alcohol use [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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).
  • Current marijuana use [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Stable living environment at the time of the follow-up (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Educational progress [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Defined as increment from baseline standing with respect to high school grade, GED certificate; post-high school or college completed
  • Employment experience (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Employed part or full-time since baseline; certificate, post-high school or college completed;
  • Engagement in job-readiness services [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Services defined as job preparedness skill-building, job internships, or educational services
  • Social support (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Future orientation (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Work-hope scale (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Self-determinism/Personal Growth Initiative (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Balance of possible selves (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Prevention and promotion orientation (Regulatory Focus) (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2017)
  • Sexual initiation / activity (vaginal) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Ever engaged in vaginal sex.
  • Current sexual activity (vaginal) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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?"
  • Current birth control use (vaginal sex) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Current condom use (vaginal sex) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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).
  • Current unprotected sex (vaginal and anal sex) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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:
    1. "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?"
    2. "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?"
  • Current sexual activity (oral) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Pregnancy [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Ever been pregnant/caused pregnancy
  • Adult communication (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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?"
  • Proportion of youth who have vaginal intercourse without the consistent use of contraception [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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:
    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".
  • Proportion of youth who have vaginal or anal sexual intercourse without the consistent use of condoms [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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:
    1. "In the past 3 months, how many times did you have vaginal sex?"
    2. "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?"
    3. "In the past 3 months, how many times did you have anal sex?"
    4. "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?"
  • Current contraception use (among females) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Current contraception use is defined as the use of one or more methods of effective contraception in the past 3 months (Trussell, 2011).
  • Number of recent unprotected vaginal intercourse acts [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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?"
  • Number of recent unprotected anal intercourse acts [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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?"
  • Current hard drug use [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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).
  • Current alcohol use [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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).
  • Current marijuana use [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Stable living environment at the time of the follow-up (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Educational progress [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Defined as increment from baseline standing with respect to high school grade, GED certificate; post-high school or college completed home or residential facility or a tenant of an apartment.
  • Employment experience (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Employed part or full-time since baseline; certificate, post-high school or college completed; home or residential facility or a tenant of an apartment.
  • Engagement in job-readiness services [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    Services defined as job preparedness skill-building, job internships, or educational (tutorial)
  • Social support (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Future orientation (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Work-hope scale (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Self-determinism/Personal Growth Initiative (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Balance of possible selves (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
  • Prevention and promotion orientation (Regulatory Focus) (current) [ Time Frame: Assessed at baseline, 5 months post-baseline, and 11 months post-baseline ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project Legacy Impact Evaluation Study
Official Title  ICMJE Project Legacy Impact Evaluation Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pregnancy
  • Sexual Behavior
  • Contraception Behavior
  • Sexually Transmitted Diseases
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: 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.).
  • Experimental: Project Legacy
    The experimental/intervention arm will receive the Project Legacy intervention
    Intervention: Behavioral: Project Legacy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2017)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Frances J LaSalle-Castro, MPH 323-361-4605 flasallecastro@chla.usc.edu
Contact: Mona Desai, MPH 323-361-3107 mdesai@chla.usc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03366636
Other Study ID Numbers  ICMJE 90AP2683-01-00
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leslie Clark, University of Southern California
Study Sponsor  ICMJE Children's Hospital Los Angeles
Collaborators  ICMJE ETR Associates
Investigators  ICMJE
Principal Investigator: Leslie F Clark, PhD, MPH University of Southern California
PRS Account Children's Hospital Los Angeles
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP