ViolencePhase 2/3NCT00527358
Evaluation of SAFER Latinos' Program to Prevent Youth Violence
A Phase 2/3 study testing SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos) in people with Violence, run by Joanne Klevens at 1 site in United States.
Trial summary
This is an evaluation of a primary prevention program to prevent youth violence by improving family cohesion, networking among families, school bonding, and access to services for Latinos in Langley Park, MD. Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence
- What is being tested?
- SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Dec 2010
- Phase
- Phase 2/3
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- youth 12-24 and their caregiver
Who cannot join
- residence outside of Langley Park or Culmore
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia
About this study
This is an evaluation of a primary prevention program to prevent youth violence by improving family cohesion, networking among families, school bonding, and access to services for Latinos in Langley Park, MD.
Read the detailed description
To prevent youth involvement in violence, outreach workers will work with families and youth to improve school bonding, family cohesion and awareness and utilization of existing services; and a youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.
Following implementation of the intervention, we will collect detailed process data (regarding implementation), and evaluate impact/outcome using a quasi-experimental design with baseline (prior to intervention) and two followup data collections in both the intervention and a control community (Culmore, Virginia), measuring change in a selected set of aggregate community variables that represent mediating factors and outcomes for youth violence in Langley Park. Data will be collected via a survey and focus groups.
- Conditions
- Violence
- Being tested
- SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)
- Keywords
- violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)Behavioural
- community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices;
- youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, provide education about avoiding violence;
- school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals;
- Youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.
| Study group | Role | What they receive |
|---|---|---|
| SAFER | Experimental | The intervention community will receive 4 services:
1. community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices;
2. youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, and provide education about avoiding violence;
3. school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals;
4. Youth drop-in center: will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training. Receives: Behavioral: SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos) |
| 2 | No intervention | Business as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth violence
Measured: within the next 2 years after intervention started
Secondary outcomes (3)
family cohesion
Measured: within the next 2 years after start of intervention
school bonding
Measured: within the next 2 years after start of intervention
exposure to antisocial, substance abusing, or violent peers
Measured: within the next 2 years after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startSep 2006
- Primary completionDec 2010
- Study completionDec 2010
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 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joanne Klevens
- Sponsor type
- US federal agency
- Collaborators
- George Washington University, Latin American Youth Center, Latino Federation of Greater Washington
- Responsible party
- Sponsor-investigator, Joanne Klevens, Centers for Disease Control and Prevention
- Investigators
- Mark Edberg, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527358
- Sponsor's protocol ID
- CDC-NCIPC-4924
- Status last verified
- Feb 2012
- First submitted
- 6 Sep 2007
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SAFER Latinos' Program to Prevent Youth Violence
- ClinicalTrials.gov ID
- NCT00527358
- Acronym / sponsor ID
- CDC-NCIPC-4924
- Conditions
- Violence
- Keywords
- violence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Joanne KlevensUS federal agency
- Collaborators
- George Washington University, Latin American Youth Center, Latino Federation of Greater Washington
- Study start
- Sep 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Sep 2007 (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 is an evaluation of a primary prevention program to prevent youth violence by improving family cohesion, networking among families, school bonding, and access to services for Latinos in Langley Park, MD.
Detailed description
To prevent youth involvement in violence, outreach workers will work with families and youth to improve school bonding, family cohesion and awareness and utilization of existing services; and a youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training.
Following implementation of the intervention, we will collect detailed process data (regarding implementation), and evaluate impact/outcome using a quasi-experimental design with baseline (prior to intervention) and two followup data collections in both the intervention and a control community (Culmore, Virginia), measuring change in a selected set of aggregate community variables that represent mediating factors and outcomes for youth violence in Langley Park. Data will be collected via a survey and focus groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAFER | Experimental | Behavioral: SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)The intervention community will receive 4 services: 1. community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices; 2. youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, and provide education about avoiding violence; 3. school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals; 4. Youth drop-in center: will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training. |
| 2 | No intervention | –Business as usual. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- youth 12-24 and their caregiver
Key exclusion criteria (1 listed)
- residence outside of Langley Park or Culmore
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 |
|---|---|---|
| SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos)1. community lay workers will do family outreach and assist families in networking with other families and accessing community services, facilitating parent-youth and family-school communication and homework help for children, and help with translation of school or government/official notices; 2. youth leaders will provide a supportive presence, help youth navigate the system at school so that they can get help if needed, disseminate information about job training and possibilities, provide education about avoiding violence; 3. school support services will offer academic support, acculturation orientation, language, conflict resolution skills training, advocacy and referrals; 4. Youth drop-in center will provide youth with an adult supervised place to "hang out", do homework, or participate in sports and job training. | Behavioural | SAFER |
Primary outcome
Youth violence
Time frame: within the next 2 years after intervention started
3 secondary outcomes
family cohesion
Time frame: within the next 2 years after start of intervention
school bonding
Time frame: within the next 2 years after start of intervention
exposure to antisocial, substance abusing, or violent peers
Time frame: within the next 2 years after start of intervention
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 10 Feb 2012.
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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.
Mark Edberg, PhD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SAFER (Seguridad, Apoyo, Familia, Educacion, y Recursos) in people with Violence, run by Joanne Klevens 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 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 10 Feb 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Youth violence (time frame: within the next 2 years after intervention started). 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 10 Feb 2012.