cSBI-M for Young Military Personnel

Substance Abuse Clinical Trial

Official title:

Computerized Screening and Brief Intervention for Young Military Personnel

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01847300
• Other study ID #: bchRFADA13012
• Status: Withdrawn
• Phase: N/A
• First received: May 2, 2013
• Last updated: October 6, 2016
• Start date: September 2013
• Est. completion date: February 2017

Study information

• Verified date: October 2016
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Substance Abuse
• Substance-Related Disorders
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alcohol use	We will measure the past-90-days alcohol use as recorded on the Time-Line-Followback Calendar	past 90 days	No
Secondary	Heavy episodic drinking	We will measure the number of episodes of heavy drinking (binge drinking)	past-90-days	No
Secondary	alcohol initiation	Rates of those initiating drinking in the past 90 days, among those who did not drink at baseline.	past-90-days	No
Secondary	Alcohol cessation	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	No