- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06940362
Changing Youth Narratives on Firearm Violence ("Run It Up") Intervention
Changing Youth Narratives on Firearm Violence: A Community Collaborative Intervention - Phases 1 and 2
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overall design for the intervention evaluation is a two group, quasi-experimental community cohort design with a pretest (baseline) and multiple post-tests (follow-ups). A baseline survey and two follow-ups of 12-16-year-old youth and one parent/guardian per youth will be collected in the intervention and comparison communities, separately measuring a number of resilience, risk-related and demographic variables, hypothesized mediators/moderators linked to the intervention and its theory of change, intervention and related media exposure, and self-report outcomes. The comparison community (Marshall Heights) has been matched to the intervention community (Washington Highlands) as closely as possible on demographic and violence data (e.g., 95% African American in the intervention community, vs 90% African American in the comparison community; both communities have high poverty rates). A preliminary analysis will be conducted at each follow-up, with full analysis after the last follow-up. The research team will also collect firearm and related violence data as well as place-based aggregated data from designated community Census tracts for two years pre-intervention to the final intervention year for both communities, either monthly or quarterly, depending on whether there are enough samples in each period, in order to conduct interrupted time series analysis (ITSA) to assess the intervention effect on community-level outcomes.
Sampling Because there is no sampling frame from which to randomize, the research team is using a targeted snowball method through community partners (the CSC) who are familiar with most community families. Recruitment will occur through these interpersonal networks, using flyers with study information and eligibility requirements, prompting a snowball process where initial contacts recruit others. This method is more productive, facilitates the consent-assent process and recruitment of parents/guardians, and may avoid inherent safety concerns compared to sending staff to knock on doors for recruitment. Further, it will likely increase awareness and trust in the effort. It will also support a community cohort design, in which the same samples are followed up over time, with an improved ability to make causal inferences.
To increase rigor, the annual survey sample size proposed in the funding application has been increased from 200 youth/200 parents to 250 youth and the same number of parents (in both communities, for a total n of 500 youth, 500 parents each wave), in order to achieve enough power in the supplemental propensity score analyses, and for dose-response analyses. Along with that, the research team (including the community partners) will implement recruiting strategies to maximize direct youth participation in the intervention activities, to reach a goal of approximately 100-150 youth participating in the intervention activity tracks. These participants assessed at baseline will be followed up at 12 and 24 months after the baseline survey, separately.
Administration The baseline and follow-up surveys will be administered via mobile phone and tablets to a community sample of youth and parents/guardians. In the intervention community, data collection will not be limited to youth who participate in the alternative trajectory intervention activity tracks, because the goal is to assess intervention effects on community youth as a whole (including those directly participating in activities). However, to improve linkage between survey data and actual intervention participants, survey and intervention participant IDs will be linked by participant names, which will be maintained in a separate password-protected secure file and not appear on any survey or intervention process data. Variables will be created indicating dose to intervention exposure including participation in the intervention activity tracks and " and "media exposure". In this way, it will be possible to assess the dose-response effect among the youth in the intervention community. The survey and data storage will use REDCap software for security and efficiency.
Process and Qualitative Measures Extensive process data will be collected, e.g. attendance of each session and satisfaction with the session for each youth participating in the intervention activity tracks. In addition, each program year, 15 youth who are involved in any program activities will be randomly selected for a one-hour interview about experiences with program media/messaging and any perceived changes resulting from this exposure. The research team will also conduct interviews with two adults named by the youth as program-related influencers or mentors, to assess any changes mentors have seen in the youth, and perceptions of factors leading to the changes. These qualitative interviews (n=45) in Years 3-5 will be conducted and analyzed using the same methods outlined for the Phase One formative research.
Analyses Originally planned analyses include descriptive analyses, Difference-in-Difference (DID) analysis to test intervention effect, sensitivity analysis to assess contamination, mediation analysis and moderation analyses based on survey data, and interrupted time series analysis (ITSA) based on community data. A number of changes have been made in the original analytical plan to increase rigor, recognizing the complexity of a quasi-experimental design with one intervention and one comparison community. First, the interrupted time series component has been strengthened in several ways. This component entails tracking a set of data at the community level that we would expect to change (in a positive direction) over time as a result of the intervention. As a minimum set of community data, each occurrence of any crime, gun-related crime, non-gun-related crime in the study Census tracts will be derived from data reported through the website crimecards.dc.gov, tracked monthly from two years before the intervention and then across the intervention period. The data will be aggregated over time and over the specific Census tracts in each community (by matching addresses to Census tract) to calculate monthly or quarterly crime rate (number of crimes divided by the population), depending on how many crimes in each community per month. In addition, the research team is seeking community-level placebo measures that will not be changed by the intervention. These will most likely include: (1) Temporary Assistance for Needy Families (TANF) data from the DC Department of Health; and (2) child poverty data from the DC Office of Planning -- across time in each Census tract and then aggregated for analysis. The ITSA with placebo outcomes will increase the robustness in the analyses. Similarly, for DID using survey data, placebo measures have been added to the survey that are not expected to change as a result of the intervention - for example, diet, or self-reported height and weight -- as an additional means to test the robustness of DID.
In addition, propensity score matching has been added as a supplemental analysis. For this, youth will be matched based on their baseline characteristics (sociodemographic and outcome variable at baseline) from the intervention community and comparison community to mimic an RCT for assessment of the intervention effect. Propensity score analysis will be implemented with "teffect psmatch" using STATA software.
Finally, the research team is collecting survey IDs, participant IDs, and tracking short-term outcome and process data collected by intervention component, social media/community event exposure, and brand equity data , allowing for analysis of intervention effect by type and degree of exposure - because it will be possible to link participant IDs and survey IDs.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mark Edberg, PhD, MA
- Phone Number: 1-202-994-3584
- Email: medberg@gwu.edu
Study Contact Backup
- Name: Nisha Sachdev, DrPH, PsyD
- Email: nasachde@email.gwu.edu
Study Locations
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20052
- Recruiting
- George Washington University Milken Institute School of Public Health
-
Contact:
- Nisha Sachdev, DrPH, PsyD
- Email: nasachde@email.gwu.edu
-
Contact:
- Mark Edberg, PhD, MA
- Phone Number: 202-994-3584
- Email: medberg@gwu.edu
-
Sub-Investigator:
- Yan Wang, MD, DrPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Resident of intervention community, within age limits
Exclusion Criteria:
• Not resident of intervention community, outside of age limits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Youth intervention arm
Training and mentoring of 12-16 year old youth in non-violent personal/career trajectories, supported by a social media campaign and a community steering committee.
|
Training and mentoring of 12-16 year old youth in non-violent personal/career trajectories, supported by a social media campaign and a community steering committee.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in youth firearm violence involvement
Time Frame: 2 1/2 years
|
Change in self-reported violence involvement by participants (via survey) and changes in community violence data (incidence, from police and health tracking data).
|
2 1/2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Edberg, PhD, MA, George Washington University
Publications and helpful links
General Publications
- Sokol R, Walton M, Lee D, Seewald L, Del Toro VM, Farooqui M, Sallabank G, Zimmerman M, Edberg M, Wang Y, Zakrison T, Tung EL, Hillegass WB, Vearrier L, Zhang L, Kutcher ME, Blachman-Demner D, Carter PM. Advancing Science to Prevent Firearm Violence in Communities: A Process for Harmonizing Studies to Develop Research Infrastructure. Prev Sci. 2024 Oct;25(7):1122-1132. doi: 10.1007/s11121-024-01723-5. Epub 2024 Sep 20.
- Edberg MC, Cleary SD, Andrade EL, Evans WD, Quinteros-Grady L, Alvayero RD, Gonzalez A. The Adelante project: Realities, challenges and successes in addressing health disparities among central American immigrant youth. Cultur Divers Ethnic Minor Psychol. 2022 Jul;28(3):402-412. doi: 10.1037/cdp0000368. Epub 2021 Dec 23.
- Edberg M. The cultural persona as nexus between structural marginalization and youth risk behavior. J Community Psychol. 2020 Sep;48(7):2138-2155. doi: 10.1002/jcop.22368.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NCR234833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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