Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

October 20, 2021 updated by: Jennifer Bogner, PhD, ABPP

Brief Intervention for Substance Misuse Following Moderate or Severe Traumatic Brain Injury (TBI): A Randomized Controlled Trial

This study is investigating one way to improve health and healthy habits after traumatic brain injury (TBI). The primary goal of this study is to determine if a brief intervention accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse during the year following injury. It is hypothesized that an adapted Screening, Education and Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per week over the year following discharge from inpatient rehabilitation, in comparison to a Screening and Education Attention Control condition (SEA control).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sustained a TBI, defined as damage to brain tissue caused by external force and evidenced by loss of consciousness, post-traumatic amnesia, skull fracture, or objective neurological findings
  • History of alcohol misuse within the year prior to injury
  • Be at least 18 years old
  • English-speaking
  • Have cleared post-traumatic amnesia
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Language impairments that would preclude participation in interview
  • Has not cleared post-traumatic amnesia before discharge

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adapted Screening and Brief Intervention
Adapted Screening and Brief Intervention: Participants will be screened for substance use, receive education regarding the effects of substance misuse, participate in a motivation interview, and participate in a booster session one month later
Behavioral: Adapted Screening and Brief Intervention (Adapted SBI)
Active Comparator: Screening & Education Attention Control
Screening & Education Attention Control: Participants will be screened for substance use, receive education regarding the effects of substance misuse, and participate in a booster session one month later
Behavioral: Screening & Education Attention Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of alcoholic drinks consumed per week in past month
Time Frame: Change from baseline to 12 months post-discharge
Number of drinks will be recorded at baseline, 6, 9, and 12 months. We will be measuring change in the number of drinks consumed of the course of the year, with the primary outcome being measured at the 12 month assessment.
Change from baseline to 12 months post-discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of alcohol binges in past month
Time Frame: Change in the number of alcohol binges baseline to 12 months post-discharge
Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men
Change in the number of alcohol binges baseline to 12 months post-discharge
Alcohol expectancies
Time Frame: 12 months post-discharge
Measured by the shortened Alcohol Expectancies Questionnaire-III
12 months post-discharge
Number of facts retained about negative consequences of substance misuse
Time Frame: 12 months post-discharge
Count of number of facts, maximum=8
12 months post-discharge
Number of alcoholic drinks consumed per week during the past month
Time Frame: Change from baseline to 3 months post-discharge
Count of number of facts, maximum=8
Change from baseline to 3 months post-discharge
Number of alcoholic drinks consumed per week in the past month
Time Frame: Change from baseline to 6 months post-discharge
Change from baseline to 6 months post-discharge
Frequency of alcohol binges in past month
Time Frame: Change from baseline to 6 months post-discharge
Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men
Change from baseline to 6 months post-discharge
Number of alcohol binges in past month
Time Frame: Change from baseline to 3 months post-discharge
Binge is defined as 4 or more drinks in a day for women, 5 or more drinks in a day for men
Change from baseline to 3 months post-discharge
Alcohol expectancies
Time Frame: 6 months post-discharge
Measured by the shortened Alcohol Expectancies Questionnaire-III
6 months post-discharge
Alcohol expectancies
Time Frame: 3 months post-discharge
Measured by the shortened Alcohol Expectancies Questionnaire-III
3 months post-discharge
Number of facts retained about negative consequences of alcohol use
Time Frame: 3 months post-discharge
Count of number of facts, maximum=8
3 months post-discharge
Number of facts retained about negative consequences of alcohol use
Time Frame: 6 months post-discharge
Count of number of facts, maximum=8
6 months post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jennifer Bogner, PhD, ABPP

Collaborators

U.S. Department of Education

Investigators

  • Principal Investigator: Jennifer A Bogner, PhD, Ohio State University Wexner Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012H0424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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