ViolenceNCT04120441
A Fighting Chance: Pilot Study of a Group Mentoring Intervention for Assault Injured Youth
A study testing Group Mentoring/Intervention in people with Violence, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence
- What is being tested?
- Group Mentoring/Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
About this study
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.
Read the 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.
- Conditions
- Violence
- Being tested
- Group Mentoring/Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Mentoring/InterventionBehavioural
Also called A Fighting Chance
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start3 Aug 2020
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Leticia Ryan, MD MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120441
- Sponsor's protocol ID
- IRB00218737
- Status last verified
- Jul 2020
- First submitted
- 7 Oct 2019
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fighting Chance: Pilot Study of a Group Mentoring Intervention for Assault Injured Youth
- ClinicalTrials.gov ID
- NCT04120441
- Acronym / sponsor ID
- IRB00218737
- Conditions
- Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group mentoring/Intervention | Experimental | Behavioral: Group Mentoring/InterventionStudy 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. |
| 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. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Mentoring/InterventionAlso: A Fighting ChanceStudy 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. | Behavioural | Group mentoring/Intervention |
Primary outcome
Proportion of intervention participants attending > 80% of sessions
Time frame: 4-6 month follow up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leticia Ryan, MD MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Mentoring/Intervention in people with Violence, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of intervention participants attending > 80% of sessions (time frame: 4-6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.