Hazardous BehaviorDISHNCT06543342
Bystander Intervention for Hazardous Drinking
A study testing Bystander Brief Motivational Intervention in people with Hazardous Behavior and Alcohol Consequences, run by Brown University at 1 site in United States.
Trial summary
The objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hazardous Behavior, Alcohol Consequences
- What is being tested?
- Bystander Brief Motivational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 15 Jul 2022
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- First-year students in one of two residence halls. The subset of participants who were selected for intervention or control had to have been exposed to others who showed risk signs in the past month.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches. A set of students will be engaged to serve as peer leaders to assist in reducing hazardous drinking behavior among their peers. This new intervention, a Bystander Brief Motivational Intervention (BBMI) spans Stages 1A and 1B of the stage model of behavioral therapies research and will utilize qualitative methods, an open trial, and a small controlled pilot trial within the targeted college community.
Read the detailed description
The objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches. Established elements from Bystander Intervention (awareness of the problem, addressing pluralistic ignorance, skill building), Brief Motivational Intervention (client-centered foundation, corrective information about community norms, protective behavioral strategies) and Social Network Analysis (measuring network ties, identifying the influence of network members), will be integrated into a brief intervention that pays particular attention to the connectedness of residents in dormitory social networks. Social network analytic methods will be used to assess the primary peer network (the college residence) and a set of individuals exposed to others drinking risks will be identified to receive the intervention. This set of students will be engaged to serve as peer leaders to assist in reducing hazardous drinking behavior among their peers. This new intervention, a Bystander Brief Motivational Intervention (BBMI) spans Stages 1A and 1B of the stage model of behavioral therapies research and will utilize qualitative methods, an open trial, and a small controlled pilot trial within the targeted college community.
- Conditions
- Hazardous Behavior, Alcohol Consequences
- Being tested
- Bystander Brief Motivational Intervention
- Medical subject headings
- Dangerous Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bystander Brief Motivational InterventionBehavioural
Group-based interactive intervention, conducted in two sessions, including multiple tasks and exercises to identify different levels of risk behavior, different types of strategies, and practicing responding to different scenarios. Personal goals for helping friends stay safe, and identifying whether intervention as a bystander was successful are included.
| Study group | Role | What they receive |
|---|---|---|
| Bystander Brief Motivational Intervention | Experimental | Two 2-hour in person sessions focusing on identifying alcohol risks among peers, determining optimal bystander strategies to use, and identifying personal barriers to intervening. Receives: Behavioral: Bystander Brief Motivational Intervention |
| Assessment Control | No intervention | Comparison group selected using the same criteria but receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to the Hazardous Drinking of Others
Number of risk signs observed in peers -validated measure
Measured: 1 month and 3 months
The Bystanders to Alcohol Risk Scale - Strategies
Number of strategies used to help others - validated measure
Measured: 1 month and 3 months
Alcohol Bystander Readiness to Help
Self-perception of readiness to help others in different situations - measure validation underway
Measured: 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start10 Jan 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hazardous BehaviorStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-group trial in which one group serves as intervention recipients and one as assessment-only controls.
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Barnett, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543342
- Sponsor's protocol ID
- AA025456
- Acronym
- DISH
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bystander Intervention for Hazardous Drinking
- ClinicalTrials.gov ID
- NCT06543342
- Acronym / sponsor ID
- DISH / AA025456
- Conditions
- Hazardous Behavior, Alcohol Consequences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 9 Aug 2024 (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 objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches. A set of students will be engaged to serve as peer leaders to assist in reducing hazardous drinking behavior among their peers. This new intervention, a Bystander Brief Motivational Intervention (BBMI) spans Stages 1A and 1B of the stage model of behavioral therapies research and will utilize qualitative methods, an open trial, and a small controlled pilot trial within the targeted college community.
Detailed description
The objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches. Established elements from Bystander Intervention (awareness of the problem, addressing pluralistic ignorance, skill building), Brief Motivational Intervention (client-centered foundation, corrective information about community norms, protective behavioral strategies) and Social Network Analysis (measuring network ties, identifying the influence of network members), will be integrated into a brief intervention that pays particular attention to the connectedness of residents in dormitory social networks. Social network analytic methods will be used to assess the primary peer network (the college residence) and a set of individuals exposed to others drinking risks will be identified to receive the intervention. This set of students will be engaged to serve as peer leaders to assist in reducing hazardous drinking behavior among their peers. This new intervention, a Bystander Brief Motivational Intervention (BBMI) spans Stages 1A and 1B of the stage model of behavioral therapies research and will utilize qualitative methods, an open trial, and a small controlled pilot trial within the targeted college community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-group trial in which one group serves as intervention recipients and one as assessment-only controls.
| Arm | Type | Receives |
|---|---|---|
| Bystander Brief Motivational Intervention | Experimental | Behavioral: Bystander Brief Motivational InterventionTwo 2-hour in person sessions focusing on identifying alcohol risks among peers, determining optimal bystander strategies to use, and identifying personal barriers to intervening. |
| Assessment Control | No intervention | –Comparison group selected using the same criteria but receive no intervention. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First-year students in one of two residence halls. The subset of participants who were selected for intervention or control had to have been exposed to others who showed risk signs in the past month.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Bystander Brief Motivational InterventionGroup-based interactive intervention, conducted in two sessions, including multiple tasks and exercises to identify different levels of risk behavior, different types of strategies, and practicing responding to different scenarios. Personal goals for helping friends stay safe, and identifying whether intervention as a bystander was successful are included. | Behavioural | Bystander Brief Motivational Intervention |
Primary outcome
Exposure to the Hazardous Drinking of Others
Time frame: 1 month and 3 months
Number of risk signs observed in peers -validated measure
The Bystanders to Alcohol Risk Scale - Strategies
Time frame: 1 month and 3 months
Number of strategies used to help others - validated measure
Alcohol Bystander Readiness to Help
Time frame: 1 month and 3 months
Self-perception of readiness to help others in different situations - measure validation underway
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 16 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bystander Brief Motivational Intervention in people with Hazardous Behavior and Alcohol Consequences, run by Brown 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 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 16 Aug 2024. 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?
Exposure to the Hazardous Drinking of Others (time frame: 1 month and 3 months). The study lists 3 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 16 Aug 2024.