ViolencePhase 1NCT00164541
An Arts-Based Initiative for the Prevention of Violence Against Women and Girls
A Phase 1 study testing Arts Based Program and Curriculum in people with Violence, run by Centers for Disease Control and Prevention at 4 sites in United States.
Trial summary
this project will evaluate a community and school based program to promote healthy relationships and prevent violence (physical, emotional and sexual dating violence) among predominately African American middle school adolescents in an urban setting (Baltimore, MD). Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Violence
- What is being tested?
- Arts Based Program and Curriculum
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,440 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2004to Sep 2006
- Phase
- Phase 1
- 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 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Students in four middle schools in urban Baltimore, MD (Dunbar, Lombard, Calverton and Lemmel Middle Schools)
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dunbar Middle School
Baltimore, Maryland, 21205
Calverton
Baltimore, Maryland, 21216
Lemmel Middle School
Baltimore, Maryland, 21216
Lombard School
Baltimore, Maryland, 21231
About this study
this project will evaluate a community and school based program to promote healthy relationships and prevent violence (physical, emotional and sexual dating violence) among predominately African American middle school adolescents in an urban setting (Baltimore, MD).
Read the detailed description
This initiative includes 4 major components: 1) A variety of arts based student activities related to violence prevention (during and after school theatre projects, during and/or after school visual arts project, and the web page design project. (All students will either directly participate in these activities or at least see them), 2) Curricular components for all 7th graders, 3) Violence prevention and early intervention student support/discussion groups, and 4) Faculty and staff training on the subject. The evaluation is a quasi-experimental pre/post test comparison group design (2 schools in each group), where our comparison schools convert to intervention schools one year after serving as comparison schools. We are using both group (student and teacher surveys) and school wide (climate of the school) measures pre and post intervention.
- Conditions
- Violence
- Being tested
- Arts Based Program, Curriculum
- Keywords
- dating violence, violence against women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arts Based ProgramBehavioural
CurriculumBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Dating violence perpetration
Measured: past 12 months
Secondary outcomes (1)
Dating violence victimization
Measured: past 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2004
- Study completionSep 2006
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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Jaqueline Campbell, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164541
- Sponsor's protocol ID
- CDC-NCIPC-3292
- Other IDs
- US4/CCU319009
- Status last verified
- Sep 2007
- First submitted
- 12 Sep 2005
- Last updated
- 21 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Arts-Based Initiative for the Prevention of Violence Against Women and Girls
- ClinicalTrials.gov ID
- NCT00164541
- Acronym / sponsor ID
- CDC-NCIPC-3292
- Conditions
- Violence
- Keywords
- dating violence, violence against women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Sep 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 14 Sep 2005 (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.
this project will evaluate a community and school based program to promote healthy relationships and prevent violence (physical, emotional and sexual dating violence) among predominately African American middle school adolescents in an urban setting (Baltimore, MD).
Detailed description
This initiative includes 4 major components: 1) A variety of arts based student activities related to violence prevention (during and after school theatre projects, during and/or after school visual arts project, and the web page design project. (All students will either directly participate in these activities or at least see them), 2) Curricular components for all 7th graders, 3) Violence prevention and early intervention student support/discussion groups, and 4) Faculty and staff training on the subject. The evaluation is a quasi-experimental pre/post test comparison group design (2 schools in each group), where our comparison schools convert to intervention schools one year after serving as comparison schools. We are using both group (student and teacher surveys) and school wide (climate of the school) measures pre and post intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students in four middle schools in urban Baltimore, MD (Dunbar, Lombard, Calverton and Lemmel Middle Schools)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Arts Based Program | Behavioural | – |
| Curriculum | Behavioural | – |
Primary outcome
Dating violence perpetration
Time frame: past 12 months
1 secondary outcome
Dating violence victimization
Time frame: past 12 months
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 21 Sep 2007.
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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.
Jaqueline Campbell, PhD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arts Based Program and Curriculum in people with Violence, run by Centers for Disease Control and Prevention at 4 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 1 inclusion and 1 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 21 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dating violence perpetration (time frame: past 12 months). 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 21 Sep 2007.