Alcohol ConsumptionBigAl2NCT02489032
Web-Based Training for EAP Alcohol Screening, Brief Intervention, and Refer
A study testing SBIRT Training & Support Tool in people with Alcohol Consumption and Alcohol Abuse, run by Oregon Center for Applied Science, Inc..
Trial summary
The goal of the proposed research is to complete the development of a web-based program to train Employee Assistance Program (EAP) and EAP-affiliated managed behavioral health organization (MBHO) practitioners to conduct screening, brief intervention, and referral to treatment (SBIRT) for problem alcohol use among… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Alcohol Abuse
- What is being tested?
- SBIRT Training & Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2016to 13 Nov 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- EAP/BH practitioners will be employed at an EAP or behavioral health organization
- have an e-mail account
- access to high-speed Internet connection
- speak and read English
Who cannot join
- younger than 18
- not an EAP practitioner
- no access to e-mail
- no access to the Internet
- do not speak and read English
About this study
The goal of the proposed research is to complete the development of a web-based program to train Employee Assistance Program (EAP) and EAP-affiliated managed behavioral health organization (MBHO) practitioners to conduct screening, brief intervention, and referral to treatment (SBIRT) for problem alcohol use among working adults.
Read the detailed description
In Phase 2, the investigators propose to develop the SBIRT Training \& Support Tool with two components: (1) online SBIRT Training for call-center and face-to-face practitioners conducting alcohol SBIRT and (2) SBIRT Support Tool with mobile/web interactive alcohol screening tools and brief intervention protocols to facilitate use of SBIRT by practitioners. The SBIRT Training component will provide practitioners with the skills, knowledge, motivation, and self-efficacy to: (a) screen their clients for unhealthy alcohol use with validated screening tools; (b) provide brief, motivational interviewing-informed intervention; and (c) make appropriate referrals. The training program will incorporate the Phase 1 content and expand the curriculum to include the use of additional validated alcohol screening tools. Content for alcohol SBIRT will be derived from NIAAA evidence-based materials.
The SBIRT Support Tool will provide a mobile/web interface for practitioners to use interactive screening and brief intervention forms with (a) prompts for validated questions in the screening or brief intervention; (b) motivational interviewing-informed dialogue suggestions; (c) online resources (i.e., standard drink list; importance, confidence rulers); and (d) alcohol education and referral information. The practitioner will use the SBIRT Support Tool to (a) screen clients for alcohol use with interactive validated screening tools; (b) provide brief intervention for individuals based on their screening score; and (c) provide referral to treatment for individuals based on their screening score.
- Conditions
- Alcohol Consumption, Alcohol Abuse
- Being tested
- SBIRT Training & Support Tool, Waitlist Control
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRT Training & Support ToolBehavioural
Program to train EAP/behavioral health practitioners in conducting alcohol SBIRT
Waitlist ControlOther
3-month wait-list and then provided access to the SBIRT training program
| Study group | Role | What they receive |
|---|---|---|
| SBIRT Training & Support Tool | Experimental | The SBIRT Training \& Support Tool has two components, both of which will be evaluated: (1) online SBIRT Training for EAP and behavioral health practitioners conducting alcohol SBIRT with their adult clients and (2) mobile/web interactive alcohol screening tools and brief intervention protocols to facilitate use of SBIRT by practitioners. Receives: Behavioral: SBIRT Training & Support Tool |
| Waitlist control | Other | Subjects randomized to the control condition will be placed on a wait-list and given access to the SBIRT Training \& Support Tool after 3 months and completion of the 3-month follow-up assessment. Receives: Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBIRT implementation
Situation judgment tests (SJT) will assess trainee's responses to real-life situations and behaviors. The SJT will consist of 9 brief (20-30 seconds) audio-based vignettes of motivational interviewing and alcohol SBIRT in typical clinical and counseling situations. For each of the 9 SJTs, trainees will identify MI/SBIRT-compliant responses.
Measured: 3 months
Secondary outcomes (3)
Perceived Competence
13-item scale assessing trainee's perceived competence (self-efficacy) for using motivational interviewing and alcohol SBIRT skills
Measured: 3 months
Knowledge
23-item scale assessing trainee's knowledge of motivational interviewing and alcohol SBIRT concepts
Measured: 3 months
Attitudes
10-item scale assessing trainee's attitudes about conducting motivational interviewing and alcohol SBIRT with clients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start22 Jun 2016
- Primary completion13 Nov 2016
- Study completion13 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Amelia J Birney, MPH, MCHES, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489032
- Sponsor's protocol ID
- BIG Al 2
- Other IDs
- 2R44AA021053
- Acronym
- BigAl2
- Status last verified
- Jan 2017
- First submitted
- 30 Jun 2015
- Last updated
- 26 Jan 2017
- 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 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Training for EAP Alcohol Screening, Brief Intervention, and Refer
- ClinicalTrials.gov ID
- NCT02489032
- Acronym / sponsor ID
- BigAl2 / BIG Al 2
- Conditions
- Alcohol Consumption, Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- 13 Nov 2016 (actual)
- Study completion
- 13 Nov 2016 (actual)
- First posted
- 2 Jul 2015 (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 the proposed research is to complete the development of a web-based program to train Employee Assistance Program (EAP) and EAP-affiliated managed behavioral health organization (MBHO) practitioners to conduct screening, brief intervention, and referral to treatment (SBIRT) for problem alcohol use among working adults.
Detailed description
In Phase 2, the investigators propose to develop the SBIRT Training \& Support Tool with two components: (1) online SBIRT Training for call-center and face-to-face practitioners conducting alcohol SBIRT and (2) SBIRT Support Tool with mobile/web interactive alcohol screening tools and brief intervention protocols to facilitate use of SBIRT by practitioners. The SBIRT Training component will provide practitioners with the skills, knowledge, motivation, and self-efficacy to: (a) screen their clients for unhealthy alcohol use with validated screening tools; (b) provide brief, motivational interviewing-informed intervention; and (c) make appropriate referrals. The training program will incorporate the Phase 1 content and expand the curriculum to include the use of additional validated alcohol screening tools. Content for alcohol SBIRT will be derived from NIAAA evidence-based materials.
The SBIRT Support Tool will provide a mobile/web interface for practitioners to use interactive screening and brief intervention forms with (a) prompts for validated questions in the screening or brief intervention; (b) motivational interviewing-informed dialogue suggestions; (c) online resources (i.e., standard drink list; importance, confidence rulers); and (d) alcohol education and referral information. The practitioner will use the SBIRT Support Tool to (a) screen clients for alcohol use with interactive validated screening tools; (b) provide brief intervention for individuals based on their screening score; and (c) provide referral to treatment for individuals based on their screening score.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBIRT Training & Support Tool | Experimental | Behavioral: SBIRT Training & Support ToolThe SBIRT Training \& Support Tool has two components, both of which will be evaluated: (1) online SBIRT Training for EAP and behavioral health practitioners conducting alcohol SBIRT with their adult clients and (2) mobile/web interactive alcohol screening tools and brief intervention protocols to facilitate use of SBIRT by practitioners. |
| Waitlist control | Other | Other: Waitlist ControlSubjects randomized to the control condition will be placed on a wait-list and given access to the SBIRT Training \& Support Tool after 3 months and completion of the 3-month follow-up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- EAP/BH practitioners will be employed at an EAP or behavioral health organization
- have an e-mail account
- access to high-speed Internet connection
- speak and read English
Key exclusion criteria (5 listed)
- younger than 18
- not an EAP practitioner
- no access to e-mail
- no access to the Internet
- do not speak and read English
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 |
|---|---|---|
| SBIRT Training & Support ToolProgram to train EAP/behavioral health practitioners in conducting alcohol SBIRT | Behavioural | SBIRT Training & Support Tool |
| Waitlist Control3-month wait-list and then provided access to the SBIRT training program | Other | Waitlist control |
Primary outcome
SBIRT implementation
Time frame: 3 months
Situation judgment tests (SJT) will assess trainee's responses to real-life situations and behaviors. The SJT will consist of 9 brief (20-30 seconds) audio-based vignettes of motivational interviewing and alcohol SBIRT in typical clinical and counseling situations. For each of the 9 SJTs, trainees will identify MI/SBIRT-compliant responses.
3 secondary outcomes
Perceived Competence
Time frame: 3 months
Knowledge
Time frame: 3 months
Attitudes
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- 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.
Amelia J Birney, MPH, MCHES principal investigator
Oregon Center for Applied Science
Questions about this trial
What is this clinical trial studying?
A study testing SBIRT Training & Support Tool in people with Alcohol Consumption and Alcohol Abuse, run by Oregon Center for Applied Science, Inc..
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SBIRT implementation (time frame: 3 months). 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 26 Jan 2017.