cSBI-M for Young Military Personnel

October 6, 2016 updated by: John R Knight, MD, Boston Children's Hospital

Computerized Screening and Brief Intervention for Young Military Personnel

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cSBI-M
Participants in this group will complete the cSBI-M screening and brief intervention program
Behavioral: cSBI-M
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.
No Intervention: Treatment as Usual
Participants in this group will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
alcohol use
Time Frame: past 90 days
We will measure the past-90-days alcohol use as recorded on the Time-Line-Followback Calendar
past 90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heavy episodic drinking
Time Frame: past-90-days
We will measure the number of episodes of heavy drinking (binge drinking)
past-90-days
alcohol initiation
Time Frame: past-90-days
Rates of those initiating drinking in the past 90 days, among those who did not drink at baseline.
past-90-days
Alcohol cessation
Time Frame: Past-90-days
We will measure the rates of those who stopped drinking in the past-90-days, among those who were drinking at baseline.
Past-90-days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John R Knight, MD, Boston Children's Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • bchRFADA13012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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