A Fighting Chance: Pilot Study of a Group Mentoring Intervention for Assault Injured Youth

This pilot study is a randomized controlled trial in which assault-injured 12-14 year old youth recruited from the emergency department (ED) are randomly assigned to standard care or "A Fighting Chance" group mentoring.

Study Overview

• Status: Completed
• Conditions: Violence
• Intervention / Treatment: Behavioral: Group Mentoring/Intervention

Detailed Description

The goal of this project is to adapt, implement and evaluate Take Charge! (a 1:1 mentoring intervention for assault-injured youth) for a group mentoring model.

This pilot study is a randomized controlled trial in which assault-injured 12-14 year old youth recruited from the emergency department are randomly assigned to standard care or "A Fighting Chance" group mentoring that includes a violence prevention curriculum and parent sessions. Immediately post-intervention and again at six-month follow up, youth violence-related, mental health and educational outcomes using validated measures will be assessed.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Children's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Injury: Eligible youth have been treated in the ED for an interpersonal intentional injuries excluding child abuse, sexual abuse, sibling fights, police fights, and other domestic violence-related fights involving relatives and/or household residents. These excluded types of violence have a different set of complex dynamics and services needs requiring separate study and intervention.
• Age: Eligible youth are age 12-14 years (i.e. up to the 14th birthday) and youths' parents/guardians are age 18 years and older.
• Mental/Physical Status: Youth and parents must have the cognitive ability to participate in the intervention. Those with severe psychopathology (i.e. severe history of mental illness with multiple psychiatric hospitalizations) or inability to comprehend questions, will be excluded.
• Language: English-speaking ability of the parent and child is necessary to enable participation in the intervention, training and assessments.
• Mentorship: Eligible youth are not currently participating in a formal mentoring program.

Exclusion criteria:

Additionally, there are youth eligibility criteria set by Y in Central Maryland policies which the investigators will follow. These include:

• Residence: Youth are not eligible if residence is outside of Baltimore City.
• Custody/child protection status: Youth are not eligible if youth have a caregiver currently involved in an ongoing custody dispute or Child Protective Services investigation. Youth are not eligible if youth live somewhere other than a residential setting with parents/guardians.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group mentoring/Intervention; Study participants randomized to intervention will be enrolled in a Y in Central Maryland group mentoring program that meets weekly over a three month period. Parents will participate in three parenting sessions. Youth study participants will be interviewed about the youth's thoughts and behaviors and the youth's medical and school records will be reviewed. Parents will also be interviewed to ask questions about the program. The study will last for 12 months and youth/parents will be interviewed at the time of enrollment and 4-6 months later.	Behavioral: Group Mentoring/Intervention; Study participants randomized to intervention will be enrolled in a Y in Central Maryland group mentoring program that meets weekly over a three month period. Parents will participate in three parenting sessions.; Other Names: A Fighting Chance
NO_INTERVENTION: Routine care/control; Study participants randomized to control will receive information about community resources. Youth study participants will be interviewed about the youth's thoughts and behaviors and the youth's medical and school records will be reviewed. Parents will also be interviewed to ask questions about the program. The study will last for 12 months and youth/parents will be interviewed at the time of enrollment and 4-6 months later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of intervention participants attending > 80% of sessions	For this pilot study, the main outcome measure is that of feasibility. Specifically, the investigators will assess feasibility by determining the proportion of intervention participants that attend >80% (10 or more) sessions.	4-6 month follow up

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Leticia Ryan, MD MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2020
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (ACTUAL): October 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB00218737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No