Alcohol AbuseNCT01847300
cSBI-M for Young Military Personnel
A study testing cSBI-M in people with Alcohol Abuse and Tobacco Dependence, run by Boston Children's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Abuse, Tobacco Dependence, Substance Abuse
- What is being tested?
- cSBI-M
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Navy personnel coming for a routine health screening
- Have email address and internet access for 12-month study period
- Provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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).
- Conditions
- Alcohol Abuse, Tobacco Dependence, Substance Abuse
- Being tested
- cSBI-M
- Keywords
- alcohol abuse, tobacco dependence, substance abuse, SBIRT
- Medical subject headings
- Alcoholism, Tobacco Use Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cSBI-MBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| cSBI-M | Experimental | Participants in this group will complete the cSBI-M screening and brief intervention program Receives: Behavioral: cSBI-M |
| Treatment as Usual | No intervention | Participants in this group will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
alcohol use
We will measure the past-90-days alcohol use as recorded on the Time-Line-Followback Calendar
Measured: past 90 days
Secondary outcomes (3)
Heavy episodic drinking
We will measure the number of episodes of heavy drinking (binge drinking)
Measured: past-90-days
alcohol initiation
Rates of those initiating drinking in the past 90 days, among those who did not drink at baseline.
Measured: past-90-days
Alcohol cessation
We will measure the rates of those who stopped drinking in the past-90-days, among those who were drinking at baseline.
Measured: Past-90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R Knight, MD, Boston Children's Hospital
- Investigators
- John R Knight, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847300
- Sponsor's protocol ID
- bchRFADA13012
- Status last verified
- Oct 2016
- First submitted
- 2 May 2013
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Screening and Brief Intervention for Young Military Personnel
- ClinicalTrials.gov ID
- NCT01847300
- Acronym / sponsor ID
- bchRFADA13012
- Conditions
- Alcohol Abuse, Tobacco Dependence, Substance Abuse
- Keywords
- alcohol abuse, tobacco dependence, substance abuse, SBIRT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 6 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cSBI-M | Experimental | Behavioral: cSBI-MParticipants in this group will complete the cSBI-M screening and brief intervention program |
| Treatment as Usual | No intervention | –Participants in this group will receive treatment as usual. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Navy personnel coming for a routine health screening
- Have email address and internet access for 12-month study period
- Provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cSBI-MIn 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. | Behavioural | cSBI-M |
Primary outcome
alcohol use
Time frame: past 90 days
We will measure the past-90-days alcohol use as recorded on the Time-Line-Followback Calendar
3 secondary outcomes
Heavy episodic drinking
Time frame: past-90-days
alcohol initiation
Time frame: past-90-days
Alcohol cessation
Time frame: Past-90-days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Knight, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cSBI-M in people with Alcohol Abuse and Tobacco Dependence, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alcohol use (time frame: past 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.