Violence in AdolescenceNCT03615716
A Multi-level Approach to Violence Prevention Among African American Adolescents
A study testing Multi-level Violence Prevention Intervention - Boys and Multi-level Violence Prevention Intervention - Caregivers in people with Violence in Adolescence, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The overall goal of this study is to advance the science of youth violence prevention and the social determinants of health by using a community-driven approach to implement a comprehensive intervention. Read more about this study
- Who is it for?
- Ages 11 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Violence in Adolescence
- What is being tested?
- Multi-level Violence Prevention Intervention - Boys and Multi-level Violence Prevention Intervention - Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 12 Jun 2019
- 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 11 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Boys Inclusion Criteria:
- Male
- Identify as African American or Black
- aged 11-14 years at the time of the study enrollment
- Reside in the targeted community
- Be able to meet after school once a week for 4-months.
Boys Exclusion Criteria:
- Not English speaking
Caregivers Inclusion Criteria:
- Identify as the primary caregiver of a boy enrolled in the study
Caregivers Exclusion Criteria:
- Not English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham
Birmingham, Alabama, 35209
About this study
Official title: A Multi-level Approach to Violence Prevention Among African American
The overall goal of this study is to advance the science of youth violence prevention and the social determinants of health by using a community-driven approach to implement a comprehensive intervention. The objective of the proposed project is to assess the feasibility, acceptability, and preliminary efficacy of an innovative, multi-level intervention that promotes adolescent protective factors and reduces risk behaviors among African American youth residing in Birmingham. Alabama.
Read the detailed description
Perceived neighborhood violence, hearing about violence in one's community, and being a victim of violence contributes to adverse psychological conditions such as anxiety, depression, and stress, which may have cascading negative effects physically and be the start of a vicious cycle. Among children, the prevalence of neighborhood violent crime is linked to symptoms of post-traumatic stress disorder (PTSD), aggressive behavior, school attendance problems, sexual risk taking, and the use of alcohol, tobacco, and other drugs.
Since childhood is a critical and fragile time with respect to developmental trajectories and relationship building, it is an important time to intervene. Previous research used a deficit model focusing on risks as opposed to an asset model, which focuses on protective factors related to prosocial and positive traits. Building the protective factors (e.g., involvement in prosocial activities, intolerant attitude toward deviance, connectedness to adults outside the family) of youth can promote well-being and reduce the risks of negative outcomes. Social-emotional learning (SEL) programming targeting adolescents is thus becoming increasingly funded because of its documented success, such as higher levels of prosocial behavior, more favorable attitudes toward school and others, and better academic achievement.
The overall goal of this study is to advance the science of youth violence prevention and the social determinants of health by using a community-driven approach to implement a comprehensive intervention. The objective of the proposed project is to assess the feasibility, acceptability, and preliminary efficacy of an innovative, multi-level intervention that promotes adolescent protective factors and reduces risk behaviors among African American youth residing in Birmingham. Alabama. According to data from the FBI's 2015 Uniform Crime Report, Birmingham is ranked as the nation's 3rd most violent city with high levels of violent crime occurring in the a neighborhood located in Northeast Birmingham, Alabama. By partnering with national and local community partners, this study proposes to design a comprehensive intervention that integrates an evidence-based, individual-level SEL program with a relationship-level mentoring component and a community-level environmental improvement component. The proposed pilot project is building on recently established community relationships. Through community capacity development funds, the investigators helped establish a community coalition in Spring of 2016 to identify and address the underlying causes of health disparities in the community. The coalition has identified violence and safety as issues that community members most desire to be addressed and has recommended strategies, such as establishing a mentoring program, providing activities for children, and organizing community improvement activities. The proposed project addresses several of these issues and our community partners have expressed enthusiastic support of the project.
The proposed project will be achieved through the following specific aims:
Aim 1: Conduct a 4-month multi-level youth violence prevention intervention that includes an individual-level social-emotional learning program with a relationship-level mentoring component and a community-level environmental improvement component. The intervention will include 20 African American male adolescents residing in a community in Birmingham, AL.
Aim 2: Assess the feasibility and acceptability of the multi-level intervention.
- Feasibility and Acceptability (Primary Outcome): Detailed process data will be collected to assess recruitment, retention, and acceptance. It is hypothesized that 20 African American adolescents (6th-8th grade) will be recruited, >80% of the participants will be retained, and >80%will accept the intervention.
- Efficacy (Secondary Outcome): To determine the effects of the intervention on aggressive behavior and prosocial behavior (protective factors). It is hypothesized that participants will have significantly lower levels of aggressive behavior and higher levels of prosocial behavior.
This study will be a significant contribution to the multi-level violence prevention literature and lay the foundation for a larger study using an experimental design to examine effects of a violence prevention intervention on individual and community health and well-being. In addition, lessons learned from this project can serve as a model to address violence prevention in similar inner-city communities in the United States.
- Conditions
- Violence in Adolescence
- Being tested
- Multi-level Violence Prevention Intervention - Boys, Multi-level Violence Prevention Intervention - Caregivers
- Keywords
- violence, adolescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level Violence Prevention Intervention - BoysBehavioural
Comprehensive, Multi-level Violence Prevention Intervention. The intervention consists of three components: (1) a 15-week after-school program, (2) group mentoring, and (3) community enhancement activities. Adolescents and mentors will attend a 2-hour weekly session at a community center, and will conduct up to four community enhancement activities. At the end of the program, a graduation celebration will be planned, and parents/guardians and stakeholders (e.g., coalition members) will be invited.
Multi-level Violence Prevention Intervention - CaregiversBehavioural
This is arm is measuring the Multi-level Violence Prevention Intervention that is administered to the boys, from the perspectives of their caregivers. The caregivers themselves will not receive an intervention, but their perspectives of the impact on the interventions on the boys will be examined
| Study group | Role | What they receive |
|---|---|---|
| Multi-level Violence Prevention Intervention - Boys | Experimental | A study examining middle school boys who have a high potential of violence based on where they live. This arm will measure outcomes in the boys. as the result of the intervention, from the perspectives of the boys. Receives: Behavioral: Multi-level Violence Prevention Intervention - Boys |
| Multi-level Violence Prevention Intervention - Caregivers | Experimental | In this study examining middle school boys who have a high potential of violence based on where they live, this arm will measure caregivers' perspectives of the boys ' outcomes. Caregivers will be surveyed pre-intervention and 4- and 6-month post intervention to explore the impact of the boys' intervention. Receives: Behavioral: Multi-level Violence Prevention Intervention - Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate behavior using the Strengths and Difficulties Questionnaire
25-item self-report Strengths and Difficulties Questionnaire (SDQ) validated for ages 11-16. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (α=.73)
Measured: At baseline
Evaluate behavior using the Strengths and Difficulties Questionnaire
25-item self-report Strengths and Difficulties Questionnaire (SDQ) validated for ages 11-16. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (α=.73)
Measured: From baseline through 4 months
Evaluate behavior using the Strengths and Difficulties Questionnaire
25-item self-report Strengths and Difficulties Questionnaire (SDQ) validated for ages 11-16. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (α=.73)
Measured: From baseline through 6 months
Child aggressive behavior and prosocial skills - for parent/guardian to complete
25-item parent Strengths and Difficulties Questionnaire (SDQ) measures child's behavior from parent perspective. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.
Measured: baseline
Child aggressive behavior and prosocial skills - for parent/guardian to complete
25-item parent Strengths and Difficulties Questionnaire (SDQ) measures child's behavior from parent perspective. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.
Measured: 4 months
Child aggressive behavior and prosocial skills - for parent/guardian to complete
25-item parent Strengths and Difficulties Questionnaire (SDQ) measures child's behavior from parent perspective. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.
Measured: 6 months
Secondary outcomes (20)
Perceived Satisfaction
6-item intervention satisfaction measure
Measured: 4 months
Participant satisfaction with mentors
adaptation of a satisfaction with patient navigator questionnaire
Measured: 4 months
Utilization - Sessions
number of sessions attended
Measured: 4 months
Utilization - community service activities
number of community activities attended
Measured: 4 months
Utilization - time with mentor
total minutes spent with mentor
Measured: 4 months
Sense of Belonging Scale
5-item 5-point likert scale measures sense of belonging in the program (i.e., connected, committed, supported, accepted). Validated among ages 9-19 (α=.93).
Measured: baseline
Sense of Belonging Scale
5-item 5-point likert scale measures sense of belonging in the program (i.e., connected, committed, supported, accepted). Validated among ages 9-19 (α=.93).
Measured: 4 months
Sense of Belonging Scale
5-item 5-point likert scale measures sense of belonging in the program (i.e., connected, committed, supported, accepted). Validated among ages 9-19 (α=.93).
Measured: 6 months
School Safety
1-item 5-point likert scale assessing agreement with the statement, "I feel safe at my school" (strongly agree to strongly disagree). Has been shown to have validity and reliability in terms of both predictors (e.g., sociodemographics) and predicting outcomes (e.g., well-being).
Measured: baseline
School Safety
1-item 5-point likert scale assessing agreement with the statement, "I feel safe at my school" (strongly agree to strongly disagree). Has been shown to have validity and reliability in terms of both predictors (e.g., sociodemographics) and predicting outcomes (e.g., well-being).
Measured: 4 months
School Safety
1-item 5-point likert scale assessing agreement with the statement, "I feel safe at my school" (strongly agree to strongly disagree). Has been shown to have validity and reliability in terms of both predictors (e.g., sociodemographics) and predicting outcomes (e.g., well-being).
Measured: 6 months
Neighborhood safety
4-item 5-point likert scale includes items such as "It's safe to walk around my neighborhood" and "I'm scared of people in my neighborhood" with higher scores indicating greater neighborhood safety (α=.77).
Measured: baseline
Neighborhood safety
4-item 5-point likert scale includes items such as "It's safe to walk around my neighborhood" and "I'm scared of people in my neighborhood" with higher scores indicating greater neighborhood safety (α=.77).
Measured: 4 months
Neighborhood safety
4-item 5-point likert scale includes items such as "It's safe to walk around my neighborhood" and "I'm scared of people in my neighborhood" with higher scores indicating greater neighborhood safety (α=.77).
Measured: 6 months
Neighborhood Cohesion
5-item 5-point likert scale measuring how much they agree with statements regarding their neighborhood and neighbors such as "people in this neighborhood can be trusted," "people in this neighborhood do not share the same values," and "there are people I can count on in this neighborhood."
Measured: baseline
Neighborhood Cohesion
5-item 5-point likert scale measuring how much they agree with statements regarding their neighborhood and neighbors such as "people in this neighborhood can be trusted," "people in this neighborhood do not share the same values," and "there are people I can count on in this neighborhood."
Measured: 4 months
Neighborhood Cohesion
5-item 5-point likert scale measuring how much they agree with statements regarding their neighborhood and neighbors such as "people in this neighborhood can be trusted," "people in this neighborhood do not share the same values," and "there are people I can count on in this neighborhood."
Measured: 6 months
Family Cohesion
12-item subscale contains items related to family communication and closeness.
Measured: baseline
Family Cohesion
12-item subscale contains items related to family communication and closeness.
Measured: 4 months
Family Cohesion
12-item subscale contains items related to family communication and closeness.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start11 Feb 2019
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study has 2 groups of participants. Only one group, middle school boys (N=20), will receive the intervention. But, pre- and post-assessments will be conducted with 2 groups: (1) boys, (2) caregivers. Caregivers (N=20) will give their perspectives of boys' behavior pre- and post- intervention.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Mei Schoenberger, University of Alabama at Birmingham
- Investigators
- Yu-Mei Schoenberger, PhD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615716
- Sponsor's protocol ID
- IRB-300000551
- Status last verified
- Aug 2019
- First submitted
- 9 Jul 2018
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-level Approach to Violence Prevention Among African American
- ClinicalTrials.gov ID
- NCT03615716
- Acronym / sponsor ID
- IRB-300000551
- Conditions
- Violence in Adolescence
- Keywords
- violence, adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 6 Aug 2018 (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.
The overall goal of this study is to advance the science of youth violence prevention and the social determinants of health by using a community-driven approach to implement a comprehensive intervention. The objective of the proposed project is to assess the feasibility, acceptability, and preliminary efficacy of an innovative, multi-level intervention that promotes adolescent protective factors and reduces risk behaviors among African American youth residing in Birmingham. Alabama.
Detailed description
Perceived neighborhood violence, hearing about violence in one's community, and being a victim of violence contributes to adverse psychological conditions such as anxiety, depression, and stress, which may have cascading negative effects physically and be the start of a vicious cycle. Among children, the prevalence of neighborhood violent crime is linked to symptoms of post-traumatic stress disorder (PTSD), aggressive behavior, school attendance problems, sexual risk taking, and the use of alcohol, tobacco, and other drugs.
Since childhood is a critical and fragile time with respect to developmental trajectories and relationship building, it is an important time to intervene. Previous research used a deficit model focusing on risks as opposed to an asset model, which focuses on protective factors related to prosocial and positive traits. Building the protective factors (e.g., involvement in prosocial activities, intolerant attitude toward deviance, connectedness to adults outside the family) of youth can promote well-being and reduce the risks of negative outcomes. Social-emotional learning (SEL) programming targeting adolescents is thus becoming increasingly funded because of its documented success, such as higher levels of prosocial behavior, more favorable attitudes toward school and others, and better academic achievement.
The overall goal of this study is to advance the science of youth violence prevention and the social determinants of health by using a community-driven approach to implement a comprehensive intervention. The objective of the proposed project is to assess the feasibility, acceptability, and preliminary efficacy of an innovative, multi-level intervention that promotes adolescent protective factors and reduces risk behaviors among African American youth residing in Birmingham. Alabama. According to data from the FBI's 2015 Uniform Crime Report, Birmingham is ranked as the nation's 3rd most violent city with high levels of violent crime occurring in the a neighborhood located in Northeast Birmingham, Alabama. By partnering with national and local community partners, this study proposes to design a comprehensive intervention that integrates an evidence-based, individual-level SEL program with a relationship-level mentoring component and a community-level environmental improvement component. The proposed pilot project is building on recently established community relationships. Through community capacity development funds, the investigators helped establish a community coalition in Spring of 2016 to identify and address the underlying causes of health disparities in the community. The coalition has identified violence and safety as issues that community members most desire to be addressed and has recommended strategies, such as establishing a mentoring program, providing activities for children, and organizing community improvement activities. The proposed project addresses several of these issues and our community partners have expressed enthusiastic support of the project.
The proposed project will be achieved through the following specific aims:
Aim 1: Conduct a 4-month multi-level youth violence prevention intervention that includes an individual-level social-emotional learning program with a relationship-level mentoring component and a community-level environmental improvement component. The intervention will include 20 African American male adolescents residing in a community in Birmingham, AL.
Aim 2: Assess the feasibility and acceptability of the multi-level intervention.
- Feasibility and Acceptability (Primary Outcome): Detailed process data will be collected to assess recruitment, retention, and acceptance. It is hypothesized that 20 African American adolescents (6th-8th grade) will be recruited, >80% of the participants will be retained, and >80%will accept the intervention.
- Efficacy (Secondary Outcome): To determine the effects of the intervention on aggressive behavior and prosocial behavior (protective factors). It is hypothesized that participants will have significantly lower levels of aggressive behavior and higher levels of prosocial behavior.
This study will be a significant contribution to the multi-level violence prevention literature and lay the foundation for a larger study using an experimental design to examine effects of a violence prevention intervention on individual and community health and well-being. In addition, lessons learned from this project can serve as a model to address violence prevention in similar inner-city communities in the United States.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study has 2 groups of participants. Only one group, middle school boys (N=20), will receive the intervention. But, pre- and post-assessments will be conducted with 2 groups: (1) boys, (2) caregivers. Caregivers (N=20) will give their perspectives of boys' behavior pre- and post- intervention.
| Arm | Type | Receives |
|---|---|---|
| Multi-level Violence Prevention Intervention - Boys | Experimental | Behavioral: Multi-level Violence Prevention Intervention - BoysA study examining middle school boys who have a high potential of violence based on where they live. This arm will measure outcomes in the boys. as the result of the intervention, from the perspectives of the boys. |
| Multi-level Violence Prevention Intervention - Caregivers | Experimental | Behavioral: Multi-level Violence Prevention Intervention - CaregiversIn this study examining middle school boys who have a high potential of violence based on where they live, this arm will measure caregivers' perspectives of the boys ' outcomes. Caregivers will be surveyed pre-intervention and 4- and 6-month post intervention to explore the impact of the boys' intervention. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Multi-level Violence Prevention Intervention - BoysComprehensive, Multi-level Violence Prevention Intervention. The intervention consists of three components: (1) a 15-week after-school program, (2) group mentoring, and (3) community enhancement activities. Adolescents and mentors will attend a 2-hour weekly session at a community center, and will conduct up to four community enhancement activities. At the end of the program, a graduation celebration will be planned, and parents/guardians and stakeholders (e.g., coalition members) will be invited. | Behavioural | Multi-level Violence Prevention Intervention - Boys |
| Multi-level Violence Prevention Intervention - CaregiversThis is arm is measuring the Multi-level Violence Prevention Intervention that is administered to the boys, from the perspectives of their caregivers. The caregivers themselves will not receive an intervention, but their perspectives of the impact on the interventions on the boys will be examined | Behavioural | Multi-level Violence Prevention Intervention - Caregivers |
Primary outcome
Evaluate behavior using the Strengths and Difficulties Questionnaire
Time frame: At baseline
25-item self-report Strengths and Difficulties Questionnaire (SDQ) validated for ages 11-16. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (α=.73)
Evaluate behavior using the Strengths and Difficulties Questionnaire
Time frame: From baseline through 4 months
25-item self-report Strengths and Difficulties Questionnaire (SDQ) validated for ages 11-16. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (α=.73)
Evaluate behavior using the Strengths and Difficulties Questionnaire
Time frame: From baseline through 6 months
25-item self-report Strengths and Difficulties Questionnaire (SDQ) validated for ages 11-16. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (α=.73)
Child aggressive behavior and prosocial skills - for parent/guardian to complete
Time frame: baseline
25-item parent Strengths and Difficulties Questionnaire (SDQ) measures child's behavior from parent perspective. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.
Child aggressive behavior and prosocial skills - for parent/guardian to complete
Time frame: 4 months
25-item parent Strengths and Difficulties Questionnaire (SDQ) measures child's behavior from parent perspective. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.
Child aggressive behavior and prosocial skills - for parent/guardian to complete
Time frame: 6 months
25-item parent Strengths and Difficulties Questionnaire (SDQ) measures child's behavior from parent perspective. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.
20 secondary outcomes
Perceived Satisfaction
Time frame: 4 months
Participant satisfaction with mentors
Time frame: 4 months
Utilization - Sessions
Time frame: 4 months
Utilization - community service activities
Time frame: 4 months
Utilization - time with mentor
Time frame: 4 months
Sense of Belonging Scale
Time frame: baseline
Sense of Belonging Scale
Time frame: 4 months
Sense of Belonging Scale
Time frame: 6 months
School Safety
Time frame: baseline
School Safety
Time frame: 4 months
School Safety
Time frame: 6 months
Neighborhood safety
Time frame: baseline
Neighborhood safety
Time frame: 4 months
Neighborhood safety
Time frame: 6 months
Neighborhood Cohesion
Time frame: baseline
Neighborhood Cohesion
Time frame: 4 months
Neighborhood Cohesion
Time frame: 6 months
Family Cohesion
Time frame: baseline
Family Cohesion
Time frame: 4 months
Family Cohesion
Time frame: 6 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 5 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Yu-Mei Schoenberger, PhD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-level Violence Prevention Intervention - Boys and Multi-level Violence Prevention Intervention - Caregivers in people with Violence in Adolescence, run by University of Alabama at Birmingham 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?
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 Aug 2019. 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?
Evaluate behavior using the Strengths and Difficulties Questionnaire (time frame: At baseline). The study lists 6 primary outcomes in all. 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 Aug 2019.