NCT01847300

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

May 2, 2013

Last Update Submit

October 6, 2016

Conditions

Keywords

alcohol abusetobacco dependencesubstance abuseSBIRT

Outcome Measures

Primary Outcomes (1)

  • alcohol use

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

    past 90 days

Secondary Outcomes (3)

  • Heavy episodic drinking

    past-90-days

  • alcohol initiation

    past-90-days

  • Alcohol cessation

    Past-90-days

Study Arms (2)

cSBI-M

EXPERIMENTAL

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

Behavioral: cSBI-M

Treatment as Usual

NO INTERVENTION

Participants in this group will receive treatment as usual.

Interventions

cSBI-MBEHAVIORAL

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.

cSBI-M

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

AlcoholismTobacco Use DisorderSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • John R Knight, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 6, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations