ViolenceTC2NCT01770873
A Multi-Center Randomized Controlled Trial of Mentoring to Prevent Youth Violence
A study testing Take Charge 2 in people with Violence, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The purpose of this study is to test whether a violence prevention curriculum delivered by Big Brothers and Big Sisters staff and mentors can reduce violence involvement for assault-injured youth. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence
- What is being tested?
- Take Charge 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Sep 2018
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Treatment for an assault injury in the emergency room
- English speaking (parent and youth)
Who cannot join
- Treatment for child abuse, sexual abuse, sibling fights, or police fights
- Severe psychopathology
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Take Charge 2- A Multi-Center Randomized Trial of Mentoring to Prevent Youth Violence: Incorporating New Communication and Information Technology
The purpose of this study is to test whether a violence prevention curriculum delivered by Big Brothers and Big Sisters staff and mentors can reduce violence involvement for assault-injured youth.
Read the detailed description
Violent injury is a major cause of morbidity and mortality among adolescents. The presence of a positive adult role model is a well-established protective factor against violence and other maladaptive outcomes among youth. Big Brothers Big Sisters (BBBS) is the largest U.S. mentoring organization with proven effectiveness in improving youth outcomes. However, these programs may be less effective with youth who already are exhibiting involvement in problem behavior at the time of program referral. Take Charge!, a mentor- and professional-implemented intervention with 10-15 year old assault-injured youth, showed promise for improving perceived self efficacy for avoiding violence and for decreasing aggression and problem behavior.
The overall goal of the proposed project is to develop, implement, and evaluate a research-informed youth development program that adapts the BBBS model to work for assault-injured youth. The aims are:
- To expand and refine Take Charge! and integrate it with BBBS practices;
- To conduct a randomized, controlled trial in which assault-injured 10-15 year old youth recruited from emergency departments in Baltimore and D.C. receive either standard emergency department follow-up care or the Take Charge! 2 intervention with assessment of violence-related, mental health, and educational outcomes;
- To conduct a comprehensive process evaluation of Take Charge! 2;
- And to accurately measure the costs of the intervention and assess cost-effectiveness.
Youth violence is a major cause of morbidity and mortality with marked disparities by race/ethnicity and socioeconomic status. This study is a critical next step in translating evidence-based research to real-world settings and practice.
- Conditions
- Violence
- Being tested
- Take Charge 2
- Keywords
- Youth, Violence, Assault-injured, Mentoring, Emergency Room, Urban
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take Charge 2Behavioural
Youth assigned to the intervention receive a Big Brothers, Big Sisters (BBBS) mentor. During the match process, BBBS staff provide 3 session on violence prevention for the youth's parents. Six months into the mentoring relationship, mentors provide 6 sessions on violence prevention for the youth.
| Study group | Role | What they receive |
|---|---|---|
| Take Charge 2 | Experimental | Receipt of BBBS mentoring plus youth and parent violence prevention curriculum Receives: Behavioral: Take Charge 2 |
| Control | No intervention | Standard emergency room protocol followed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fighting
Have you been in a physical fight in the past 30 days?
Measured: Past 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Tina L Cheng, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770873
- Sponsor's protocol ID
- NA_00075613
- Other IDs
- TC2-2P20, 2P20MD000198-11
- Acronym
- TC2
- Status last verified
- Oct 2018
- First submitted
- 16 Jan 2013
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lindstrom Johnson S, Jones V, Ryan L, DuBois DL, Fein JA, Cheng TL. Investigating Effects of Mentoring for Youth with Assault Injuries: Results of a Randomized-Controlled Trial. Prev Sci. 2022 Nov;23(8):1414-1425. doi: 10.1007/s11121-022-01406-z. Epub 2022 Jul 25.
PubMed 35877056
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take Charge 2- A Multi-Center Randomized Trial of Mentoring to Prevent Youth Violence: Incorporating New Communication and Information Technology
- ClinicalTrials.gov ID
- NCT01770873
- Acronym / sponsor ID
- TC2 / NA_00075613
- Conditions
- Violence
- Keywords
- Youth, Violence, Assault-injured, Mentoring, Emergency Room, Urban
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Oct 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 18 Jan 2013 (estimated)
- 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.
The purpose of this study is to test whether a violence prevention curriculum delivered by Big Brothers and Big Sisters staff and mentors can reduce violence involvement for assault-injured youth.
Detailed description
Violent injury is a major cause of morbidity and mortality among adolescents. The presence of a positive adult role model is a well-established protective factor against violence and other maladaptive outcomes among youth. Big Brothers Big Sisters (BBBS) is the largest U.S. mentoring organization with proven effectiveness in improving youth outcomes. However, these programs may be less effective with youth who already are exhibiting involvement in problem behavior at the time of program referral. Take Charge!, a mentor- and professional-implemented intervention with 10-15 year old assault-injured youth, showed promise for improving perceived self efficacy for avoiding violence and for decreasing aggression and problem behavior.
The overall goal of the proposed project is to develop, implement, and evaluate a research-informed youth development program that adapts the BBBS model to work for assault-injured youth. The aims are:
- To expand and refine Take Charge! and integrate it with BBBS practices;
- To conduct a randomized, controlled trial in which assault-injured 10-15 year old youth recruited from emergency departments in Baltimore and D.C. receive either standard emergency department follow-up care or the Take Charge! 2 intervention with assessment of violence-related, mental health, and educational outcomes;
- To conduct a comprehensive process evaluation of Take Charge! 2;
- And to accurately measure the costs of the intervention and assess cost-effectiveness.
Youth violence is a major cause of morbidity and mortality with marked disparities by race/ethnicity and socioeconomic status. This study is a critical next step in translating evidence-based research to real-world settings and practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Take Charge 2 | Experimental | Behavioral: Take Charge 2Receipt of BBBS mentoring plus youth and parent violence prevention curriculum |
| Control | No intervention | –Standard emergency room protocol followed |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Treatment for an assault injury in the emergency room
- English speaking (parent and youth)
Key exclusion criteria (2 listed)
- Treatment for child abuse, sexual abuse, sibling fights, or police fights
- Severe psychopathology
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 |
|---|---|---|
| Take Charge 2Youth assigned to the intervention receive a Big Brothers, Big Sisters (BBBS) mentor. During the match process, BBBS staff provide 3 session on violence prevention for the youth's parents. Six months into the mentoring relationship, mentors provide 6 sessions on violence prevention for the youth. | Behavioural | Take Charge 2 |
Primary outcome
Fighting
Time frame: Past 30 days
Have you been in a physical fight in the past 30 days?
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 9 Oct 2018.
- Derived from this study: PubMed 35877056Lindstrom Johnson S, Jones V, Ryan L, DuBois DL, Fein JA, Cheng TL. Investigating Effects of Mentoring for Youth with Assault Injuries: Results of a Randomized-Controlled Trial. Prev Sci. 2022 Nov;23(8):1414-1425. doi: 10.1007/s11121-022-01406-z. Epub 2022 Jul 25.
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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.
Tina L Cheng, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take Charge 2 in people with Violence, run by Johns Hopkins University at 2 sites 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 2 inclusion and 2 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Fighting (time frame: Past 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01770873, which also lists 1 linked publication.
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 9 Oct 2018.