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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04120441
Other study ID # IRB00218737
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2020
Est. completion date December 31, 2020

Study information

Verified date July 2020
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 31, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Johns Hopkins Children's Center Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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