Study Will Examine the Impact of Project WithNCT04795999
Opportunities Beyond the Narrative: An Intervention for Justice-Involved Youth
A study testing Project With in people with Study Will Examine the Impact of Project With, run by WestEd at 1 site in United States.
Trial summary
WestEd and its partners Urban Strategies, the Los Angeles County Probation Department, Boys Republic, California Family Life Center, and Eggleston Youth Centers Inc. are conducting a quasi-experimental design to evaluate an innovative teen pregnancy prevention program, Project With, for incarcerated and other… Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Study Will Examine the Impact of Project With
- What is being tested?
- Project With
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 15 Jul 2024
- 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 15-19
- Residing in one of the Los Angeles County Probation Department camps or group homes within a partnered network
- Have the cognitive ability to complete the baseline and follow-up surveys in English or Spanish
- Need to be at the facilities for at least 8 weeks to complete the program
Who cannot join
- Outside of age criteria
- Not residing in one of the Los Angeles County Probation Department camps or group homes within a partnered network
- Does not have the cognitive ability to complete the baseline and follow-up surveys in English or Spanish
- Not remaining at the facilities for 8 weeks or more
- Youth who participated in a previous evaluation wave as part of the treatment or comparison group cannot participate in the evaluation a second time (i.e., during a second wave)
Trial locations and contacts
1 site in 1 country.
About this study
WestEd and its partners Urban Strategies, the Los Angeles County Probation Department, Boys Republic, California Family Life Center, and Eggleston Youth Centers Inc. are conducting a quasi-experimental design to evaluate an innovative teen pregnancy prevention program, Project With, for incarcerated and other justice-involved youth in Southern California. Project With is a 12-lesson literary-based curriculum that utilizes group discussions of literary works and films to address personal relationships and sexual health topics. This study involves youth (age 15-19) at high risk for involvement in risky sexual behaviors, including teen pregnancy. The intervention shows potential to promote optimal health and reduce teen pregnancy and sexually transmitted infections (STIs) among incarcerated and other justice-involved youth, based on a previous formative evaluation of the intervention in 2018-2020. The purpose of this study is to test the curriculum on a population of incarcerated and other justice-involved youth.
Read the detailed description
Urban Strategies was funded by a Teen Pregnancy Prevention (TPP) grant from the Office of Population Affairs (OPA) within the Department of Health and Human Services (DHHS) to conduct a rigorous evaluation of a TPP program, Project With, to determine the impact of this innovative literary-based curriculum for incarcerated and other justice-involved youth. Project With is a 12-lesson literary-based curriculum, typically delivered in six weekly sessions, with each session having two one-hour long lessons and a meal with facilitators in between the two lessons. Each lesson includes a discussion of selected literary works, including poetry, short stories, and excerpts from films and other videos. The intervention shows potential to promote optimal health and reduce teen pregnancy and sexually transmitted infections (STIs) among incarcerated and other justice-involved youth. This intervention builds upon a former TPP grant. A formative evaluation of the intervention with OPA funding was carried out from 2018-2020. The formative evaluation showed that the curriculum, which explores healthy and unhealthy relationships as they appear within literary works and is facilitated by a caring mentor using a culturally attuned approach, deeply engages incarcerated youth.
This study involves youth aged 15-19 who are incarcerated/justice-involved and who are at high risk for involvement in risky sexual behaviors, including teen pregnancy. The findings from this study are intended to contribute to research on teen pregnancy, sexual health, and healthy relationships. The population of justice-involved/incarcerated youth face historical, structural, and environmental factors that bring about distressing sexual health disparities. Nationwide, 20% of incarcerated youth already have a child or are either pregnant or expecting a child they fathered (Sedlak \& Bruce, 2016). Rates of teen fatherhood for incarcerated youth are seven times higher than their peers, and rates of teen motherhood for incarcerated girls are one-third higher than national averages. Along with disparities related to teen pregnancy, incarcerated youth have high rates of trauma, thus any intervention for these youth must be trauma-informed. A 2010 Office of Juvenile Justice and Delinquency Prevention (OJJDP) report on the needs of incarcerated youth found 70% of all youth had experienced at least one childhood trauma, and 30% had experienced physical abuse, sexual abuse, or both. This study was designed to contribute to our understanding of what works with this population and to strengthen our knowledge base around developing and implementing a sexual health and personal relationships program.
The study will roll out in waves. During each wave a cohort of 8-12 youth from each facility will participate in Project With. After Urban Strategies implements Project With in a given facility, they will wait a period of time (e.g., one week to several months) and will then implement the program with a new cohort of youth. Using this design, each facility will participate in the study multiple times.
- Being tested
- Project With
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project WithBehavioural
There are 12 lessons in Project With, typically delivered in six weekly sessions, with each session having two one-hour long lessons and a meal with facilitators in between the two lessons. Each lesson includes a discussion of selected literary works, including poetry, short stories, and excerpts from films and other videos. The curriculum is intended to be delivered to groups of 8-12 youth. In ideal program delivery, participants also share a meal with each other and with the Youth Advocate. Shared mealtimes create group cohesion and allow Youth Advocates to connect with participants on a personal level, building trust. At the end of the Project With curriculum, youth will partake in an offsite day excursion to Camp Eaton, a wooded camp outside of Los Angeles. At Camp Eaton, Youth Advocates will lead a Project With session, lunch, bonding activities and games, and an opportunity to engage in an outdoor activity.
| Study group | Role | What they receive |
|---|---|---|
| Project With program | Experimental | Project With is a 12-lesson literary-based curriculum, delivered by Youth Advocates to youth in juvenile justice facilities and group homes in Southern California either in person or virtually, under COVID-19 contingencies. Program schedule is determined by the facility. The goals of Project With are to promote optimal health and reduce teen pregnancy and sexually transmitted infections (STIs). Receives: Behavioral: Project With |
| Treatment as usual | No intervention | The counterfactual condition for the study is a business-as-usual condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risky sexual behaviors
The outcome will be assessed with three items that assess whether youth had sexual intercourse with multiple partners, sexual intercourse without a condom, and sexual intercourse without using any method of birth control in the past three months (Rotz et al., 2016).
Measured: Six months after the baseline
Secondary outcomes (5)
Ability to resist temptations and provocations
The outcome will be measured with six items from Svensson et al.'s (2010) seven-item scale. The items (e.g., "I get angry very fast.") have shown good reliability with youth aged 12 to 17 (α = .78; Svensson et al., 2010) and will be rated on a scale from 1 (not like me at all) to 5 (very much like me).
Measured: Two and six months after the baseline
Planfulness
The outcome will be measured with a slightly modified version of Wills et al.'s (2007) six-item scale. The items (e.g., "I like to plan things ahead of time.") showed acceptable reliability (α = .73; Wills et al., 2007) with a sample of ninth graders and the items will be rated on a scale from 1 (not like me at all) to 5 (very much like me).
Measured: Two and six months after the baseline
Acceptance of intimate partner violence
The outcome will be measured with the five-item general violence subscale from the Acceptance of Couple Violence Scale (McRae et al., 2018). The items (e.g., "There are times when violence between dating partners is okay.") in the subscale showed excellent reliability with a sample of young adults (α = .93; McRae et al., 2018) and will be rated on a scale from 1 (strongly disagree) to 5 (strongly agree).
Measured: Two and six months after the baseline
Self-efficacy to avoid risky sexual behavior
The outcome will be measured with a modified version of the Galavotti et al. (1995) Condom Use Self-Efficacy Scale that measures self-efficacy for condom use. The scale includes five items that ask the respondent to indicate how sure they are that they would be able to use a condom in a range of situations (e.g., "If you have been using alcohol or other drugs...?"). The items will be rated on a 1 (not at all sure) to 5 (very sure) scale. Galavotti et al.'s (1995) Condom Use Self-Efficacy Scale showed high reliability with a sample of young adults (α = .88).
Measured: Two and six months after the baseline
Intentions to engage in risky sexual behavior
The outcome will be measured with three items that were TPP performance measures. The items will assess whether the youth intend in the next year to 1) have sexual intercourse, 2) use a condom if they have sex, and 3) use any effective method of birth control if they have sex. The three items will be rated on a 1 (no, definitely not) to 4 (yes, definitely).
Measured: Two and six months after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Feb 2021
- Primary completion31 Dec 2023
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study Will Examine the Impact of Project WithStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Model description
- The treatment condition involves participation in a teen pregnancy prevention program, Project With. The comparison condition for the study is treatment as usual.
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- WestEd
- Sponsor type
- University, hospital or other
- Collaborators
- Urban Strategies, Department of Health and Human Services
- Responsible party
- Principal investigator, Jonathan Nakamoto, WestEd
- Investigators
- Jonathan Nakamoto, PhD, Principal investigator, WestEd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795999
- Sponsor's protocol ID
- 2020-03-4
- Status last verified
- Jul 2025
- First submitted
- 9 Mar 2021
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunities Beyond the Narrative: An Intervention for Justice-Involved Youth
- ClinicalTrials.gov ID
- NCT04795999
- Acronym / sponsor ID
- 2020-03-4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- WestEdUniversity, hospital or other
- Collaborators
- Urban Strategies, Department of Health and Human Services
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
WestEd and its partners Urban Strategies, the Los Angeles County Probation Department, Boys Republic, California Family Life Center, and Eggleston Youth Centers Inc. are conducting a quasi-experimental design to evaluate an innovative teen pregnancy prevention program, Project With, for incarcerated and other justice-involved youth in Southern California. Project With is a 12-lesson literary-based curriculum that utilizes group discussions of literary works and films to address personal relationships and sexual health topics. This study involves youth (age 15-19) at high risk for involvement in risky sexual behaviors, including teen pregnancy. The intervention shows potential to promote optimal health and reduce teen pregnancy and sexually transmitted infections (STIs) among incarcerated and other justice-involved youth, based on a previous formative evaluation of the intervention in 2018-2020. The purpose of this study is to test the curriculum on a population of incarcerated and other justice-involved youth.
Detailed description
Urban Strategies was funded by a Teen Pregnancy Prevention (TPP) grant from the Office of Population Affairs (OPA) within the Department of Health and Human Services (DHHS) to conduct a rigorous evaluation of a TPP program, Project With, to determine the impact of this innovative literary-based curriculum for incarcerated and other justice-involved youth. Project With is a 12-lesson literary-based curriculum, typically delivered in six weekly sessions, with each session having two one-hour long lessons and a meal with facilitators in between the two lessons. Each lesson includes a discussion of selected literary works, including poetry, short stories, and excerpts from films and other videos. The intervention shows potential to promote optimal health and reduce teen pregnancy and sexually transmitted infections (STIs) among incarcerated and other justice-involved youth. This intervention builds upon a former TPP grant. A formative evaluation of the intervention with OPA funding was carried out from 2018-2020. The formative evaluation showed that the curriculum, which explores healthy and unhealthy relationships as they appear within literary works and is facilitated by a caring mentor using a culturally attuned approach, deeply engages incarcerated youth.
This study involves youth aged 15-19 who are incarcerated/justice-involved and who are at high risk for involvement in risky sexual behaviors, including teen pregnancy. The findings from this study are intended to contribute to research on teen pregnancy, sexual health, and healthy relationships. The population of justice-involved/incarcerated youth face historical, structural, and environmental factors that bring about distressing sexual health disparities. Nationwide, 20% of incarcerated youth already have a child or are either pregnant or expecting a child they fathered (Sedlak \& Bruce, 2016). Rates of teen fatherhood for incarcerated youth are seven times higher than their peers, and rates of teen motherhood for incarcerated girls are one-third higher than national averages. Along with disparities related to teen pregnancy, incarcerated youth have high rates of trauma, thus any intervention for these youth must be trauma-informed. A 2010 Office of Juvenile Justice and Delinquency Prevention (OJJDP) report on the needs of incarcerated youth found 70% of all youth had experienced at least one childhood trauma, and 30% had experienced physical abuse, sexual abuse, or both. This study was designed to contribute to our understanding of what works with this population and to strengthen our knowledge base around developing and implementing a sexual health and personal relationships program.
The study will roll out in waves. During each wave a cohort of 8-12 youth from each facility will participate in Project With. After Urban Strategies implements Project With in a given facility, they will wait a period of time (e.g., one week to several months) and will then implement the program with a new cohort of youth. Using this design, each facility will participate in the study multiple times.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment condition involves participation in a teen pregnancy prevention program, Project With. The comparison condition for the study is treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Project With program | Experimental | Behavioral: Project WithProject With is a 12-lesson literary-based curriculum, delivered by Youth Advocates to youth in juvenile justice facilities and group homes in Southern California either in person or virtually, under COVID-19 contingencies. Program schedule is determined by the facility. The goals of Project With are to promote optimal health and reduce teen pregnancy and sexually transmitted infections (STIs). |
| Treatment as usual | No intervention | –The counterfactual condition for the study is a business-as-usual condition. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 15-19
- Residing in one of the Los Angeles County Probation Department camps or group homes within a partnered network
- Have the cognitive ability to complete the baseline and follow-up surveys in English or Spanish
- Need to be at the facilities for at least 8 weeks to complete the program
Key exclusion criteria (5 listed)
- Outside of age criteria
- Not residing in one of the Los Angeles County Probation Department camps or group homes within a partnered network
- Does not have the cognitive ability to complete the baseline and follow-up surveys in English or Spanish
- Not remaining at the facilities for 8 weeks or more
- Youth who participated in a previous evaluation wave as part of the treatment or comparison group cannot participate in the evaluation a second time (i.e., during a second wave)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project WithThere are 12 lessons in Project With, typically delivered in six weekly sessions, with each session having two one-hour long lessons and a meal with facilitators in between the two lessons. Each lesson includes a discussion of selected literary works, including poetry, short stories, and excerpts from films and other videos. The curriculum is intended to be delivered to groups of 8-12 youth. In ideal program delivery, participants also share a meal with each other and with the Youth Advocate. Shared mealtimes create group cohesion and allow Youth Advocates to connect with participants on a personal level, building trust. At the end of the Project With curriculum, youth will partake in an offsite day excursion to Camp Eaton, a wooded camp outside of Los Angeles. At Camp Eaton, Youth Advocates will lead a Project With session, lunch, bonding activities and games, and an opportunity to engage in an outdoor activity. | Behavioural | Project With program |
Primary outcome
Risky sexual behaviors
Time frame: Six months after the baseline
The outcome will be assessed with three items that assess whether youth had sexual intercourse with multiple partners, sexual intercourse without a condom, and sexual intercourse without using any method of birth control in the past three months (Rotz et al., 2016).
5 secondary outcomes
Ability to resist temptations and provocations
Time frame: Two and six months after the baseline
Planfulness
Time frame: Two and six months after the baseline
Acceptance of intimate partner violence
Time frame: Two and six months after the baseline
Self-efficacy to avoid risky sexual behavior
Time frame: Two and six months after the baseline
Intentions to engage in risky sexual behavior
Time frame: Two and six months after the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Nakamoto, PhD principal investigator
WestEd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project With in people with Study Will Examine the Impact of Project With, run by WestEd at 1 site 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 4 inclusion and 5 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 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Risky sexual behaviors (time frame: Six months after the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2025.