NCT07070414

Brief Summary

This study aims to improve a short motivational conversation to better help young adults who were injured in assaults and also use alcohol or cannabis. Researchers will gather both interview and survey data from young adults who came to the emergency department after an assault and currently use alcohol or cannabis. Guided by a theory about risky behaviors, the study will focus on how confident young people feel about making changes to their alcohol and cannabis use, and how their friends and family influence their alcohol and cannabis use and involvement in injuries from assault. The team will follow a step-by-step process used by the NIH to adapt and test the improved motivational conversation in the emergency department.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

November 3, 2025

Status Verified

October 1, 2025

Enrollment Period

1.5 years

First QC Date

July 8, 2025

Last Update Submit

October 30, 2025

Conditions

Keywords

alcohol misusecannabis misuse

Outcome Measures

Primary Outcomes (4)

  • Feasibility assessed by recruitment

    Recruitment measured as the percentage of those invited/those who enrolled

    Day 0 and 30

  • Feasibility assessed by randomization

    Recruitment measured as the percentage of screened eligible participants who enroll/those who receive either intervention or control arm

    Day 0 and 30

  • Feasibility assessed by retention

    Recruitment measured as the percentage of those enrolled who have received either intervention or control arm/ participants who have completed all 30-day follow up assessments

    Day 0 and 30

  • Acceptability assessed by Acceptability of Intervention Measure (AIM)

    Acceptability of the intervention will be assessed using the Acceptability of Intervention Measure (AIM). It has 4-items scored on a 5-point Likert scale summed to achieve a total score. Total score range of 0-20. Higher scores indicate more acceptability.

    Day 0

Study Arms (2)

Brief Negotiation Interview intervention (BNI) (adapted)

EXPERIMENTAL

Participants randomized to the intervention arm will receive a brief motivational interview designed to increase motivation to reduce alcohol and/or cannabis use and engagement in treatment referral at 30-days. A referral includes a contact number to addiction treatment (primary care and/or specialty addiction care consistent with diagnostic criteria) and injury prevention services at the Yale Hospital Violence Intervention Program.

Behavioral: Brief Negotiation Interview intervention (BNI) (adapted)

Control Group

NO INTERVENTION

Control group will receive contact referrals only. A referral includes a contact number to addiction treatment (primary care and/or specialty addiction care consistent with diagnostic criteria) and injury prevention services at the Yale Hospital Violence Intervention Program.

Interventions

A brief motivational interview designed to increase motivation to reduce alcohol and/or cannabis use and engagement in treatment referral.

Brief Negotiation Interview intervention (BNI) (adapted)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aim 1:
  • Be clients of the Yale Hospital Violence Intervention Program (YHVIP)
  • Be between the ages of 18-25 y/o upon study enrollment
  • Have sustained an intentional injury inflicted by another person not considered to be a boy/girlfriend, fiancée, or spouse in the past year
  • Report current alcohol and/or cannabis misuse
  • Be English-speaking and able to provide informed consent.
  • Aim 2 and 3:
  • Present to Yale New Haven Hospital ED for an intentional injury inflicted by another person not considered to be a boy/girlfriend, fiancée, or spouse
  • Be between the ages of 18-25 y/o upon study enrollment
  • Report current alcohol and/or cannabis misuse
  • Be English-speaking and able to provide informed consent.

You may not qualify if:

  • Aim 1:
  • Be actively suicidal or severely cognitively impaired precluding informed consent
  • Sustain an intentional injury from a boy/girlfriend, fiancée, or spouse or sexual assault
  • Be incarcerated or in police custody
  • Currently engaged in addiction treatment
  • Aim 2 and 3:
  • Be actively suicidal or severely cognitively impaired precluding informed consent
  • Sustain intentional injury from a boy/girlfriend, fiancée, spouse or by sexual assault
  • Be incarcerated or in police custody
  • Currently engaged in addiction treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Department of Emergency Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Interventions

Acclimatization

Intervention Hierarchy (Ancestors)

Adaptation, PhysiologicalPhysiological PhenomenaAdaptation, BiologicalBiological Phenomena

Study Officials

  • Edouard Coupet, MD, MS

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edouard Coupet Jr., MD, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 17, 2025

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

November 3, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

De-identified individual-level data will be shared 6 months after publication for up to 3 years

Locations