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Not yet recruitingNCT07931651TGPUpdated Nov 12, 2026

Wancantognaka Project (The Generosity Project)

An interventional study of The Wancantognaka Project (The Generosity Project; TGP) in Lakota Adapted Crime Prevention Through Environmental Design (CPTED) Program to Reduce Interpersonal Community Violence, sponsored by University of Michigan. Not yet recruiting at 1 site in United States. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Michigan · Not applicable, Interventional, and Prevention

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Non-randomized
Ages
13 Years to 19 Years
Sex
All
01

Study summary

The goal of this study is to examine whether a place-based, community-led, and culturally grounded Crime Prevention Through Environmental Design (CPTED) intervention can prevent and reduce interpersonal community violence (ICV) among youth living on the Pine Ridge Reservation. The study will evaluate The Wancantognaka Project (The Generosity Project; TGP), which combines community-led environmental improvement projects with culturally grounded youth programming. Youth ages 13-19 will participate in sessions led by Lakota Elders, Traditional Healers, and/or Traditional Knowledge Keepers focused on leadership, cultural teachings, community engagement, and implementing projects to improve community spaces.

The primary aims of the study are to: (1) Develop and implement TGP in partnership with community members; (2) Assess implementation, community acceptance, perceived impact, and costs; (3) Examine whether TGP increases protective factors and reduces risk factors for interpersonal violence among youth in the intervention community compared to youth in a similar comparison community not receiving the intervention; and (4) Examine whether TGP reduces rates of community violence compared to the comparison community.

Read the detailed description

Interpersonal community violence (ICV), including physical assaults, violence between groups, and threats or use of weapons, is a significant public health concern among American Indian/Alaska Native (AI/AN) populations, including youth. Lakota youth living on the Pine Ridge Reservation face substantial challenges related to community violence. Despite growing knowledge about factors associated with community violence, research evaluating culturally grounded violence prevention approaches in Tribal communities remains limited.

Crime Prevention Through Environmental Design (CPTED) is a promising approach to preventing community violence. CPTED combines improvements to physical environments (e.g., lighting, community gardens, and improvements to shared spaces) with social strategies (e.g., community engagement, relationship building, and collective action) to create safer and more supportive communities. Busy Streets Theory (BST), which informs this study, emphasizes community participation, local ownership, and strengthening social connections through community-led improvements to neighborhood environments. This approach aligns with Lakota cultural teachings, including honoring Unci Maka (Mother Earth), Wacantognaka (generosity), Mitakuye Oyasin (all are related), Wolakota (being a good relative), and Wakanyeja Kin Wakan Pi (children are sacred).

The Wancantognaka Project (The Generosity Project; TGP) is a community-led, culturally grounded CPTED intervention designed to prevent and reduce interpersonal community violence among youth ages 13-19 on the Pine Ridge Reservation. The project integrates community-designed environmental improvements with culturally grounded youth programming led by Lakota Elders, Traditional Healers, and/or Traditional Knowledge Keepers. Youth programming will focus on leadership, cultural teachings, community engagement, and participation in projects intended to strengthen community spaces and connections.

The study uses a community-based participatory action research (CBPAR) approach, engaging youth, Elders, Traditional Healers, Traditional Knowledge Keepers, community members, and interdisciplinary researchers throughout intervention development, implementation, and evaluation. A Community Advisory Board and/or Program Steering Committee will help guide project activities to ensure they reflect community priorities, cultural teachings, and local knowledge.

The study has four primary aims:

  1. Intervention Development and Implementation:Collaboratively develop and implement TGP, including culturally grounded CPTED projects and youth programming informed by community priorities and Lakota cultural teachings.
  2. Implementation Evaluation: Examine intervention implementation, community acceptance, perceived impact, and costs, using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
  3. Youth Outcomes: Evaluate whether TGP increases protective factors (e.g., sense of community, positive cultural identity, social support, and positive youth development) and reduces risk factors and behaviors associated with interpersonal violence (e.g., substance use, delinquency, and violent behaviors) among youth in the intervention community compared to youth in a similar comparison community that does not receive TGP.
  4. Community Violence Outcomes: Evaluate whether TGP reduces rates of community violence, including violence involving youth ages 13-19, in the intervention community compared to the comparison community.

The study uses a longitudinal, quasi-experimental design to compare youth and community-level outcomes between an intervention community and a demographically similar comparison community on the Pine Ridge Reservation. Youth will complete surveys at baseline, immediately following the intervention, and at 6- and 12-month follow-ups. Community-level violence outcomes will be assessed using police incident data collected before and after intervention implementation.

Findings will contribute to understanding the feasibility, acceptability, implementation, and potential effectiveness of culturally grounded, community-led environmental approaches to preventing interpersonal community violence in Tribal communities.

02

Conditions studied

  • Lakota Adapted Crime Prevention Through Environmental Design (CPTED) Program to Reduce Interpersonal Community Violence

Keywords

  • Community Violence
  • Interpersonal Violence
  • Youth Violence
  • Firearm Violence
03

In context

Lead sponsor

University of Michigan is the lead sponsor of 1,507 studies on the registry; 193 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be between the ages of 13 to 19
  • Must live in or spend the majority of their time in the Treatment or Control Community.

Exclusion criteria

Exclusion Criteria:

  • NOT between the ages of 13 to 19
  • DO NOT live in or spend the majority of their time in the Treatment or Control Community.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    Intervention

    The intervention group will participate in the The Wancantognaka Project (The Generosity Project; TGP) for Treatment Community on the Pine Ridge Reservation

    Behavioral: The Wancantognaka Project (The Generosity Project; TGP)

  • No intervention
    Control

    The control group includes youth from Control Community, a demographically similar community to Treatment Community. The control group will not receive the TGP intervention.

Interventions

  • BehavioralThe Wancantognaka Project (The Generosity Project; TGP)

    The Wancantognaka Project (The Generosity Project; TGP) for Treatment Community will involve programming sessions for youth taught by Lakota Elders, Traditional Healers, and/or Traditional Knowledge Keepers. TGP will also involve planning and implementing CPTED projects in residential areas. Example CPTED projects include building inipis (sweat lodges) for ceremony and culturally-grounded murals.

06

What researchers measure

Primary outcomes

  1. Positive Youth Development

    Participant responses to items from the Positive Youth Development Scale to measure positive development (e.g., competence, confidence, character, caring, and connection). The 17-item scale includes likert response options ranging from 1 = Strongly Disagree to 4 = Strongly agree and an option not to respond to the question. Higher scores indicate greater positive youth development.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  2. Positive Cultural Identity

    Participant responses to items from the Multigroup Ethnic Identity Measure to measure ethnic identity development among Lakota Youth. The 6-item scale includes likert response options ranging from 1 = Strongly Disagree to 5 = Strongly agree and an option not to respond to the question. Higher scores indicate greater ethnic identity development.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  3. Collective Efficacy

    Participant responses to 9 items from the Collective Efficacy scale. The first four items includes response options ranging from 1 = Very likely to 5 = Very Unlikely. The last five items includes response options ranging from 1 = Strongly Agree to 5 = Strongly Disagree. All items include an option not to respond to the question. Higher scores indicate lower collective efficacy.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

  4. Social Support

    Participant responses to 8 items from the Multidimensional Perceived Social Support scale to measure forms of social support received from friends and adults. Thescale includes response options ranging from 0 = Very Strongly Disagree to 7 = Very Strongly Agree and an option not to respond to the question. Higher scores indicate greater perceived social support.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

  5. Academic and Career Commitment

    Participant responses to items from the Personal Responsibility Education Program scale to measure academic and career goals. The 5-item scale includes response options ranging from 0 = Not at all true of me to 3 = Extremely True of Me and an option not to respond to the question. Higher scores indicate greater academic and career commitment.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

  6. Future Orientation

    Participant responses to items from the Future orientation scale to measure goal setting. The 6-item scale includes response options ranging from 1 = Not true about me to 4 = Mostly true about me and an option not to respond to the question. Higher scores indicate greater future orientation.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

  7. Emotion Regulation

    Participant responses to items from the Difficulties in Emotion Regulation Short Form scale to measure emotion regulation. The 18-item scale includes response options ranging from 1 = Almost never to 5 = Almost always and an option not to respond to the question. Higher scores indicate greater difficulties with emotion regulation.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

  8. Purpose Beyond the Self

    Participant responses to items from the Claremont Purpose Beyond the Self scale to measure purpose. The 4-item scale includes response options ranging from 0 = Almost never to 4 = Almost all the Time and an option not to respond to the question. Higher scores indicate greater purpuse beyond the self.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

  9. Sense of Community

    Participant responses to items from the Brief Sense of Community scale to measure how respondents feel about their community. The 8-item scale includes response options ranging from 1= Strongly Agree to 5 = Strongly Disagree and an option not to respond to the question. Higher scores indicate lower sense of community.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

  10. Fight Avoidance Scale

    Participant responses to items from the Fight Avoidance scale to measure respondent perception of their ability to stay out of fights. The 5-item scale includes response options ranging from 0 = Not at all to 5 = Extremely and an option not to respond to the question. Higher scores indicate greater ability to avoid fighting.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

  11. Adolescent General Self-efficacy scale

    Participant responses to items of self-efficacy scale to measure self-efficacy (e.g., confidence, capability, and self-reliance). The 10 item scale has likert response options ranging from 1 = Not at all true to 4 = Exactly true and a option to not respond to the question. Higher score indicates more self-efficacy.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  12. Alcohol Use

    Participant responses to two items from the Alcohol Use YRBS scale to measure alcohol use in the past 30 days. One item includes likert response options ranging from A. I did not drink alcohol to G. I drank all 30 days. The second item measures the largest number of drinks in one session and item responses ranged from A. I did not drink alcohol to H. 10 or more drinks. Higher scores indicate greater alcohol use.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  13. Drug Use

    Participant responses to three items from the Drug Use (YRBS) to measure drug use amount and different types in the past 30 days. All three have a multiple choice responses with options ranging from 0. 0 times to 5. 40 or more times. There is a option to not respond to the question. Higher scores indicate a greater drug use.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  14. Sexual Violence

    Participant responses to six items from the sexual violence YRBS scale to measure sexual violence in the past six months. Two items evaluate sexual violence between non-dating partners and four items evaluate dating sexual violence. Items have multiple choice responses with options ranging from 0) 0 times to 4) 6 or more times and an option not to response to the question. Dating sexual violence items include the option 5) I was not dating in the past six months. Higher scores indicate greater sexual violence exposure.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  15. Retaliatory Attitudes

    Participant responses to items from the Retaliatory Attitudes scale to measure the endorsement of revenge for wrongdoing. The 7-item scale includes likert response options ranging from 1 = Strongly Agree to 5 = Strongly agree and an option not to respond to the question. Lower scores indicate greater retaliatory attitudes.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  16. Intention to Acquire

    Participant responses to two items from the Intention to Acquire scale to measure whether youth wanted to acquire a firearm. One item asks about whether youth ever wished to access a gun with response options 0 = No and 1 = Yes. The second item asks about reasons for wanting a gun with the option to select all that apply. Reasons for wanting gun access include protection and to get respect. Both items include the option not to respond.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  17. Firearm Access

    Participant responses to three items from the Firearm Carriage scale to measure firearm carriage in the past 6 months, 3 months, and 30 days. The second item asks about reasons for wanting a gun with the option to select all that apply. Reasons for wanting gun access include protection and to get respect. Both items include the option not to respond. The item measuring past 6 month carriage includes response options ranging from 0 = Never to 6 = 20+ times. The past 3 month carriage item includes response options ranging from 0 = Never to 10 Everyday. The past 30 day carriage includes a dropdown with options ranging from 0 to 30 days. Each item includes the option not to answer.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  18. Violent Offending

    Participant responses to items from the Violent Offending scale to measure the endorsement of violent behaviors. The 9-item scale includes likert response options ranging from 0 = Never to 6 = 20+ times and an option not to respond to the question. Higher scores indicate greater violent offenses.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

  19. Community Violence

    Participant responses to items from the Community Violence scale to measure the exposure to community violence. The 9-item scale includes response options ranging from 1 = Yes and 0 = No and an option not to respond to the question. Higher scores indicate greater violent offenses.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

  20. Delinquency

    Participant responses to items from the Delinquency scale to measure delinquent behaviors. The 7-item scale includes response options ranging from 0 = Never to 6 = 20+ times and an option not to respond to the question. Higher scores indicate greater delinquency behaviors.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline).

Secondary outcomes

  1. Community Outcomes

    Indicators of violent crime in the Treatment and Control communities involve youth will be drawn from crime incident data files exported from the Ogala Sioux Tribe (OST) Public Safety.

    Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline), and 12-month follow-up (1 year and 2 months after baseline)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Jul 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartEst.
Nov 10, 2026
Primary completionEst.
Jul 1, 2027
CompletionEst.
Jul 1, 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931651
Responsible party
Katie M Edwards (Professor, School of Social Work, University of Michigan) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Katie M Edwards, PhD
Contact
edkatie@umich.edu
734-647-8812

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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