Web-Based Training for EAP Alcohol Screening, Brief Intervention, and Refer (BigAl2)

January 24, 2017 updated by: Oregon Center for Applied Science, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • younger than 18
  • not an EAP practitioner
  • no access to e-mail
  • no access to the Internet
  • do not speak and read English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SBIRT Training & Support Tool
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.
Behavioral: SBIRT Training & Support Tool
Program to train EAP/behavioral health practitioners in conducting alcohol SBIRT
Other: Waitlist control
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.
Other: Waitlist Control
3-month wait-list and then provided access to the SBIRT training program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Competence
Time Frame: 3 months
13-item scale assessing trainee's perceived competence (self-efficacy) for using motivational interviewing and alcohol SBIRT skills
3 months
Knowledge
Time Frame: 3 months
23-item scale assessing trainee's knowledge of motivational interviewing and alcohol SBIRT concepts
3 months
Attitudes
Time Frame: 3 months
10-item scale assessing trainee's attitudes about conducting motivational interviewing and alcohol SBIRT with clients
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Center for Applied Science, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amelia J Birney, MPH, MCHES, Oregon Center for Applied Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIG Al 2
  • 2R44AA021053 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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