Violence in AdolescenceNCT04192318
Evaluating Outcomes for Youth Receiving Hospital-based Violence Prevention With and Without a Community-level Initiative
A study testing Bridging the Gap, Communities that Care (CTC) and Treatment as usual in people with Violence in Adolescence, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to test if a hospital-based violence prevention strategy with a community-level initiative is effective for cross-cutting violence prevention in violently injured youth. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Violence in Adolescence
- What is being tested?
- Bridging the Gap, Communities that Care (CTC) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 10 Feb 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Violently injured youth receiving treatment at VCU
- Aged between 12 and 21 years old
- Living in Richmond City
- 1. Parent/caregiver of the youth participant 2. Parent/caregivers must be 18 years old or older
Who cannot join
- Non-English speaking
- Ages <12 and >21 years
- Prisoners are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to test if a hospital-based violence prevention strategy with a community-level initiative is effective for cross-cutting violence prevention in violently injured youth.
Read the detailed description
This study will test if youth who receive the Bridging the Gap (BTG) and Communities that Care (CTC Plus) will see greater improvements than youth who either receive BTG only, CTC Plus only or no intervention. This study will allow researchers to learn more about the intervention's effectiveness for a range of violent outcomes. It will also help researchers understand if violence prevention efforts affect other behaviors, such as drug use and rates of violent re-injury.
Participants will be asked to complete surveys about their behavior, personality, and experiences, and their parent/child's personality, behavior, and experiences. These surveys take about 45-60 minutes to complete. These questionnaires will be completed before the intervention has taken place and then again 6 months later. Participation in this study will last up to 6 months. Approximately 408 individuals will participate in this study.
- Conditions
- Violence in Adolescence
- Being tested
- Bridging the Gap, Communities that Care (CTC), Treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridging the GapBehavioural
Bridging the Gap is a hybrid model for violence prevention which integrates a hospital-based brief violence intervention (BVI) delivered to the patient while in hospital with a wrap-around community case management prevention strategy.
Communities that Care (CTC)Other
In CTC programs stakeholders elect evidence-based prevention strategies that are most appropriate for their community. These evidence-based strategies target their community's specific needs, such as reducing risk factors while supporting and increasing protective factors.
Treatment as usualOther
Treat and release
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based violence prevention with community initiative | Experimental | Youth who are living in communities that receive Communities that Care Prevention System (CTC) will also receive Bridging the Gap (BTG), a hospital-based violence prevention program with 6-months of community case management. Receives: Behavioral: Bridging the Gap; Other: Communities that Care (CTC) |
| Hybrid hospital based violence prevention | Experimental | Youth who do not live in a community that has CTC but will receive BTG. Receives: Behavioral: Bridging the Gap |
| Treatment as usual | Active comparator | Youth living in a community without the CTC program and will receive treatment as usual (TAU) in the hospital. Receives: Other: Treatment as usual |
| Treatment as usual with community initiative | Experimental | Youth living in a community with the CTC program and will receive treatment as usual (TAU) in the hospital. Receives: Other: Communities that Care (CTC); Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in youth violence - self report
Self-report aggression
Measured: Baseline to 6 months
Change in youth violence - caregiver report
Caregiver-report of youth aggression
Measured: Baseline to 6 months
Change in youth dating violence
Self-report physical and psychological dating aggression
Measured: Baseline to 6 months
Change in youth sexual violence
Self-report sexual aggression
Measured: Baseline to 6 months
Secondary outcomes (6)
Re-injury rate
Hospital records of number of youth participants who experienced another injury due to violence between the intervention and 6-month follow-up
Measured: 6 months
Community resources
Self-report: Number of community resources youth are engaging in
Measured: 6 months
Lost to follow-up rates
Study report: The number of youth who we are unable to complete the follow-up assessment for because they are unreachable or decline to continue participation.
Measured: 6 months
Change in trauma symptoms
Self-report trauma symptoms
Measured: Baseline to 6 months
Change in substance use
Self-report of substance use
Measured: Baseline to 6 months
Change in alcohol use
Self-report of alcohol use
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start10 Feb 2020
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Why it stopped: Due to COVID, enrollment and data collection was shut down. Project was funded by training grant which ended before COVID restrictions were sufficiently lifted to resume enrollment.
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 Virginia Commonwealth 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Nicholas Thomson, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192318
- Sponsor's protocol ID
- HM20017786
- Other IDs
- 1K01CE003160-01
- Status last verified
- Mar 2022
- First submitted
- 6 Dec 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Outcomes for Youth Receiving Hospital-based Violence Prevention With and Without a Community-level Initiative
- ClinicalTrials.gov ID
- NCT04192318
- Acronym / sponsor ID
- HM20017786
- Conditions
- Violence in Adolescence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID, enrollment and data collection was shut down. Project was funded by training grant which ended before COVID restrictions were sufficiently lifted to resume enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 10 Dec 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.
The purpose of this research study is to test if a hospital-based violence prevention strategy with a community-level initiative is effective for cross-cutting violence prevention in violently injured youth.
Detailed description
This study will test if youth who receive the Bridging the Gap (BTG) and Communities that Care (CTC Plus) will see greater improvements than youth who either receive BTG only, CTC Plus only or no intervention. This study will allow researchers to learn more about the intervention's effectiveness for a range of violent outcomes. It will also help researchers understand if violence prevention efforts affect other behaviors, such as drug use and rates of violent re-injury.
Participants will be asked to complete surveys about their behavior, personality, and experiences, and their parent/child's personality, behavior, and experiences. These surveys take about 45-60 minutes to complete. These questionnaires will be completed before the intervention has taken place and then again 6 months later. Participation in this study will last up to 6 months. Approximately 408 individuals will participate in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hospital-based violence prevention with community initiative | Experimental | Behavioral: Bridging the Gap, Other: Communities that Care (CTC)Youth who are living in communities that receive Communities that Care Prevention System (CTC) will also receive Bridging the Gap (BTG), a hospital-based violence prevention program with 6-months of community case management. |
| Hybrid hospital based violence prevention | Experimental | Behavioral: Bridging the GapYouth who do not live in a community that has CTC but will receive BTG. |
| Treatment as usual | Active comparator | Other: Treatment as usualYouth living in a community without the CTC program and will receive treatment as usual (TAU) in the hospital. |
| Treatment as usual with community initiative | Experimental | Other: Communities that Care (CTC), Other: Treatment as usualYouth living in a community with the CTC program and will receive treatment as usual (TAU) in the hospital. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Violently injured youth receiving treatment at VCU
- Aged between 12 and 21 years old
- Living in Richmond City
- 1. Parent/caregiver of the youth participant 2. Parent/caregivers must be 18 years old or older
Key exclusion criteria (3 listed)
- Non-English speaking
- Ages <12 and >21 years
- Prisoners are excluded
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 |
|---|---|---|
| Bridging the GapBridging the Gap is a hybrid model for violence prevention which integrates a hospital-based brief violence intervention (BVI) delivered to the patient while in hospital with a wrap-around community case management prevention strategy. | Behavioural | Hospital-based violence prevention with community initiative, Hybrid hospital based violence prevention |
| Communities that Care (CTC)In CTC programs stakeholders elect evidence-based prevention strategies that are most appropriate for their community. These evidence-based strategies target their community's specific needs, such as reducing risk factors while supporting and increasing protective factors. | Other | Hospital-based violence prevention with community initiative, Treatment as usual with community initiative |
| Treatment as usualTreat and release | Other | Treatment as usual, Treatment as usual with community initiative |
Primary outcome
Change in youth violence - self report
Time frame: Baseline to 6 months
Self-report aggression
Change in youth violence - caregiver report
Time frame: Baseline to 6 months
Caregiver-report of youth aggression
Change in youth dating violence
Time frame: Baseline to 6 months
Self-report physical and psychological dating aggression
Change in youth sexual violence
Time frame: Baseline to 6 months
Self-report sexual aggression
6 secondary outcomes
Re-injury rate
Time frame: 6 months
Community resources
Time frame: 6 months
Lost to follow-up rates
Time frame: 6 months
Change in trauma symptoms
Time frame: Baseline to 6 months
Change in substance use
Time frame: Baseline to 6 months
Change in alcohol use
Time frame: Baseline to 6 months
Results and safety
The study was stopped early (reason given: Due to COVID, enrollment and data collection was shut down. Project was funded by training grant which ended before COVID restrictions were sufficiently lifted to resume enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: Yes. Anonymized data will be available for sharing.
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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.
Nicholas Thomson, PhD principal investigator
Virginia Commonwealth 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 Bridging the Gap, Communities that Care (CTC) and Treatment as usual in people with Violence in Adolescence, run by Virginia Commonwealth 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 4 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: stopped early, as of the sponsor's last update on 25 Mar 2022. 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 was stopped early (reason given: Due to COVID, enrollment and data collection was shut down. Project was funded by training grant which ended before COVID restrictions were sufficiently lifted to resume enrollment.). Results are not available in the source record.
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?
Change in youth violence - self report (time frame: Baseline to 6 months). The study lists 4 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 25 Mar 2022.