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cSBI-M for Young Military Personnel

Primary Purpose

Alcohol Abuse, Tobacco Dependence, Substance Abuse

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cSBI-M
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Alcohol Abuse focused on measuring alcohol abuse, tobacco dependence, substance abuse, SBIRT

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Navy personnel coming for a routine health screening
  • Have email address and internet access for 12-month study period
  • Provide informed consent

Exclusion Criteria:

  • Unable to read or understand English at a 6th grade level
  • Unavailable for 2 of the 4 follow-ups
  • Medically or emotionally unstable at the time of the visit

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cSBI-M

Treatment as Usual

Arm Description

Participants in this group will complete the cSBI-M screening and brief intervention program

Participants in this group will receive treatment as usual.

Outcomes

Primary Outcome Measures

alcohol use
We will measure the past-90-days alcohol use as recorded on the Time-Line-Followback Calendar

Secondary Outcome Measures

Heavy episodic drinking
We will measure the number of episodes of heavy drinking (binge drinking)
alcohol initiation
Rates of those initiating drinking in the past 90 days, among those who did not drink at baseline.
Alcohol cessation
We will measure the rates of those who stopped drinking in the past-90-days, among those who were drinking at baseline.

Full Information

First Posted
May 2, 2013
Last Updated
October 6, 2016
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01847300
Brief Title
cSBI-M for Young Military Personnel
Official Title
Computerized Screening and Brief Intervention for Young Military Personnel
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
not funded
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this project is to test the efficacy of a computer-facilitated Screening and Brief Intervention system adapted for Military use (cSBI-M) in reducing substance use among 18- to 25-yr-old U.S. Navy and U.S. Marine Corps personnel (USN/USMCs). The aims and hypotheses of this project are to: 1)Test the effects of cSBI-M on any alcohol use. Hypothesis: Among 18- to 25-yr-old USN/USMCs coming for routine health screenings, those receiving cSBI-M will have lower rates of any alcohol use at follow-ups compared to TAU. 2) Test the effects of cSBI-M separately as a preventive, early therapeutic, and risk-reduction intervention. Hypotheses: (a) Among 18- to 25-yr-old non-drinking USN/USMCs (negative history of past-12-months drinking at baseline), those receiving cSBI-M will have lower rates of drinking initiation and heavy episodic drinking (HED, a.k.a. "binge" drinking). (b) Among 18- to 25-yr-old drinking USN/USMCs, those receiving cSBI-M will have higher rates of drinking cessation, reduced intensity of drinking (e.g., past-3-months drinking days, HED, and driving after drinking or riding with a drinking driver.(3) Test the effects of cSBI-M on tobacco use; explore its effects on other drug use. (4) Assess potential moderators (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use), mediators (e.g., Patient to Provider Connectedness,17 perceived harmfulness of alcohol and drug use), and explore cSBI-M's mechanism of action. Hypotheses: among 12- to 18-yr-old patients coming for routine care, those receiving c-ASBI will have 1) lower rates of any alcohol use, of drinking initiation and riding with a driver who has been drinking, and 2) higher rates of drinking cessation, reduced intensity of drinking, heavy episodic drinking and driving after drinking or riding with a driver who has been drinking.
Detailed Description
The goal of this project is to test the efficacy of a computer-facilitated Screening and Brief Intervention system adapted for Military use (cSBI-M) in reducing substance use among 18- to 25-yr-old U.S. Navy and U.S. Marine Corps personnel (USN/USMCs). The aims and hypotheses of this project are to: 1)Test the effects of cSBI-M on any alcohol use. Hypothesis: Among 18- to 25-yr-old USN/USMCs coming for routine health screenings, those receiving cSBI-M will have lower rates of any alcohol use at 3-, 6-, 9- and 12-month follow-ups than Treatment As Usual (TAU). 2) Test the effects of cSBI-M separately as a preventive, early therapeutic, and risk-reduction intervention. Hypotheses: (a) Among 18- to 25-yr-old non-drinking USN/USMCs (negative history of past-12-months drinking at baseline), those receiving cSBI-M will have lower rates of drinking initiation and heavy episodic drinking (HED, a.k.a. "binge" drinking) at 3-, 6-, 9- and 12-month follow-ups than TAU. (b) Among 18- to 25-yr-old drinking USN/USMCs (positive history of past-12-months drinking at baseline), those receiving cSBI-M will have higher rates of drinking cessation, reduced intensity of drinking (e.g., past-3-months drinking days, HED, and driving after drinking or riding with a drinking driver at 3-, 6-, 9- and 12-month follow-ups than TAU. (3) Test the effects of cSBI-M on tobacco use; explore its effects on other drug use. (4) Assess potential moderators (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use), mediators (e.g., Patient to Provider Connectedness,17 perceived harmfulness of alcohol and drug use), and explore cSBI-M's mechanism of action. Hypotheses: among 12- to 18-yr-old patients coming for routine care, those receiving c-ASBI will have 1) lower rates of any alcohol use, of drinking initiation and riding with a driver who has been drinking, and 2) higher rates of drinking cessation, reduced intensity of drinking, heavy episodic drinking and driving after drinking or riding with a driver who has been drinking, at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Tobacco Dependence, Substance Abuse
Keywords
alcohol abuse, tobacco dependence, substance abuse, SBIRT

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cSBI-M
Arm Type
Experimental
Arm Description
Participants in this group will complete the cSBI-M screening and brief intervention program
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Participants in this group will receive treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
cSBI-M
Intervention Description
In cSBI-M participants complete a computerized screen for alcohol and tobacco use and then view 10 pages describing the health effects of substance use and true life stories of those affected by substance use.
Primary Outcome Measure Information:
Title
alcohol use
Description
We will measure the past-90-days alcohol use as recorded on the Time-Line-Followback Calendar
Time Frame
past 90 days
Secondary Outcome Measure Information:
Title
Heavy episodic drinking
Description
We will measure the number of episodes of heavy drinking (binge drinking)
Time Frame
past-90-days
Title
alcohol initiation
Description
Rates of those initiating drinking in the past 90 days, among those who did not drink at baseline.
Time Frame
past-90-days
Title
Alcohol cessation
Description
We will measure the rates of those who stopped drinking in the past-90-days, among those who were drinking at baseline.
Time Frame
Past-90-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Navy personnel coming for a routine health screening Have email address and internet access for 12-month study period Provide informed consent Exclusion Criteria: Unable to read or understand English at a 6th grade level Unavailable for 2 of the 4 follow-ups Medically or emotionally unstable at the time of the visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Knight, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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cSBI-M for Young Military Personnel

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