NCT04120441

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 5, 2021

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

October 7, 2019

Last Update Submit

January 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group mentoring/Intervention

EXPERIMENTAL

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

Routine care/control

NO INTERVENTION

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.

Interventions

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.

Also known as: A Fighting Chance
Group mentoring/Intervention

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Leticia Ryan, MD MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 9, 2019

Study Start

August 3, 2020

Primary Completion

December 1, 2020

Study Completion

December 31, 2020

Last Updated

January 5, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations