Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

Study Overview
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Brief Summary
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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).

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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Adapted Screening and Brief Intervention (Adapted SBI)
* Behavioral: Screening & Education Attention Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapted Screening and Brief Intervention<br>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)<br> <br> |
| Active Comparator: Screening & Education Attention Control<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of alcoholic drinks consumed per week in past month | 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 | 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 | Measured by the shortened Alcohol Expectancies Questionnaire-III | 12 months post-discharge | 
| Number of facts retained about negative consequences of substance misuse | Count of number of facts, maximum=8 | 12 months post-discharge | 
| Number of alcoholic drinks consumed per week during the past month | 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 |  | Change from baseline to 6 months post-discharge | 
| Frequency of alcohol binges in past month | 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 | 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 | Measured by the shortened Alcohol Expectancies Questionnaire-III | 6 months post-discharge | 
| Alcohol expectancies | Measured by the shortened Alcohol Expectancies Questionnaire-III | 3 months post-discharge | 
| Number of facts retained about negative consequences of alcohol use | Count of number of facts, maximum=8 | 3 months post-discharge | 
| Number of facts retained about negative consequences of alcohol use | Count of number of facts, maximum=8 | 6 months post-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury