NCT03308877

Brief Summary

This is a randomized clinical trial to study ways of helping justice-involved people change to more healthy behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

5.5 years

First QC Date

October 9, 2017

Results QC Date

October 10, 2024

Last Update Submit

March 11, 2025

Conditions

Substance UseViolence

Outcome Measures

Primary Outcomes (3)

  • Percent Days Abstinent

    Percent Days not using alcohol or drugs

    6 months

  • Substance Use Consequences (SIP-AD)

    Short Inventory of Problems with Alcohol or Drugs (SIP-AD) Range 0-45 higher = more problems

    6 months

  • Violent Charges

    Number of violent charges during follow-up from Statewide Database

    2 years

Study Arms (2)

Brief Motivational Intervention (BMI)

EXPERIMENTAL
Behavioral: BMIBehavioral: Stadard Care (SC)

Standard Care (SC)

ACTIVE COMPARATOR
Behavioral: Stadard Care (SC)

Interventions

BMIBEHAVIORAL

Four 45-minute, brief motivational sessions for substance use

Brief Motivational Intervention (BMI)
Stadard Care (SC)BEHAVIORAL

Standard procedures at pretrial program + assessement

Brief Motivational Intervention (BMI)Standard Care (SC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In Monroe County Pretrial Services Program

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pretrial Services, Inc.

Rochester, New York, 14642, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Marc T. Swogger, Associate Professor, Psychiatry and Medicine
Organization
University of Rochester Medical Center
marc_swogger@urmc.rochester.edu
585-301-7738

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 13, 2017

Study Start

February 1, 2018

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

March 18, 2025

Results First Posted

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)