Clinical trial NCT01847300: cSBI-M for Young Military Personnel
Official title: Computerized Screening and Brief Intervention for Young Military Personnel
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Abuse
Tobacco Dependence
Substance Abuse
Keywords: alcohol abuse
tobacco dependence
substance abuse
SBIRT
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

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

Primary outcomes:
measure: alcohol use
timeFrame: past 90 days
Secondary outcomes:
measure: Heavy episodic drinking
timeFrame: past-90-days
measure: alcohol initiation
timeFrame: past-90-days
measure: Alcohol cessation
timeFrame: Past-90-days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John R Knight, MD
role: PRINCIPAL_INVESTIGATOR
References: