Multimedia Toolkits to Implement 12-Step Recovery Concepts in Group Counseling

March 27, 2023 updated by: Treatment Research Institute
This study is developing and testing a 12-step toolkit with five modules, training counselors to use them, and studying their frequency of use, desirability, effectiveness and patient outcomes. The toolkit includes counselor written guides, posters, client worksheets, engagement activities, and videos designed to be shown during substance abuse treatment group sessions to explain and encourage 12-step participation.

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

The study has three aims. Aim 1 involves the development of an evidence-based 12-step facilitation toolkit curriculum. Toolkit structure and content is grounded in theory and empirical findings, and incorporates feedback from 12-step facilitation experts and individuals with a history of substance abuse. Aim 2 consists of implementing the resulting five-module Toolkit in a multi-site randomized controlled trial using a pre-/post-Toolkit training design that includes 1- and 6-month post-training assessments. Group counselors employed at community-based outpatient and inpatient substance abuse treatment programs will be randomly assigned to a Toolkit or treatment-as-usual condition. Data obtained from audiotaped sessions will identify between group differences in counselor adherence to 12-step content and skillfulness. Additional data will be collected on counselor satisfaction, 12-step attitudes and beliefs, and 12-step knowledge, as well as on Toolkit acceptability, feasibility, and short-term sustainability. Aim 3 will determine whether exposure to the Toolkit curriculum results in stable 12-step involvement and decreased self-reported substance use among clients.

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.
3483

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08108
        • Genesis Counseling Centers
    • New York
      • Brooklyn, New York, United States, 11201
        • Phoenix House
    • Pennsylvania
      • Eagleville, Pennsylvania, United States, 19408
        • Eagleville Hospital
      • Levittown, Pennsylvania, United States, 19020
        • Livengrin Foundation
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian
      • Philadelphia, Pennsylvania, United States, 19102
        • Rehab After Work
      • Philadelphia, Pennsylvania, United States, 19116
        • Self-Help Movement
      • Philadelphia, Pennsylvania, United States, 19132
        • Sobreity Through Outpatient
      • Philadelphia, Pennsylvania, United States, 19139
        • The Kirkbride Center
      • Philadelphia, Pennsylvania, United States, 19148
        • The Wedge Recovery Centers
      • Philadelphia, Pennsylvania, United States, 19382
        • Gaudenzia Inc.

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 for Counselors:

  • Over 18 years of age
  • Employed at a participating substance abuse treatment facility
  • Provide treatment in a group format

Exclusion Criteria for Counselors:

  • At the time of the project they do not have primary responsibility for conducting at least three substance abuse group sessions per week
  • Their therapy group is normally scheduled to run less than 50 minutes, or more than 150 minutes
  • Unable to provide valid informed consent

Inclusion Criteria for Clients:

  • Over 18 years of age
  • Attending an observed group of a participating counselor
  • (For participation in the Follow-Up Study/Aim 3 only) patients must endorse heavy drinking, alcohol-related difficulties, or poor prior 12-step participation

Exclusion Criteria for Clients:

- Unable to provide valid informed consent

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: Treatment
  • 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: Toolkit
Counselors randomized to the toolkit (TK) condition will receive a one to three hour standardized toolkit orientation that will include a description of the overall goal of the toolkit curriculum comprised of five modules, the purpose of each individual element of the toolkit, and an introduction to the toolkit teaching aids such as counselor guides, posters, and patient materials (hand-outs, sampling menus, worksheets, etc). TK counselor participants then conduct group treatment sessions using the toolkit materials with their patient participants.
Behavioral: Multimedia 12-Step Toolkit
The Multimedia 12-Step Toolkit includes counselor written guides, posters, client worksheets, engagement activities, and videos designed to be shown during group treatment sessions to explain and encourage 12-step participation.
Active Comparator: Treatment as Usual
Counselors assigned to the Treatment as Usual (TAU) attention control condition complete a training that reviews the same five 12-step topics that are included in the toolkit, but they do not receive any toolkit materials. TAU counselor participants then conduct group treatment sessions on the 12-step topics without using toolkit materials.
Behavioral: Treatment as Usual
Treatment as Usual is defined as five standard 12-step facilitation group sessions as counselors would normally conduct with their clients.

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
Change in counselor content adherence from baseline, as measured by the Group Observation Rating System
Time Frame: 0, 1, 6 months
Counselor adherence to 12-step concepts covered in group sessions assessed using the Group Observation Rating System which consists of items designed to assess general counseling competency skills and 12-step facilitation items
0, 1, 6 months
Change in counselor therapeutic skillfulness from baseline, as measured by the Group Observation Rating System
Time Frame: 0, 1, 6 months
Counselor therapeutic skillfulness when delivering 12-step content in group sessions assessed using the Group Observation Rating System which consists of items designed to assess general counseling competency skills and 12-step facilitation items
0, 1, 6 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
Change in counselor satisfaction from baseline, as measured by the Counselor Satisfaction Form
Time Frame: 0, 1, 6 months
Counselor satisfaction with their group sessions as measured by the Counselor Satisfaction Form which assesses counselors' overall satisfaction with the five 12-step groups
0, 1, 6 months
Change in counselor 12-step attitudes and beliefs from baseline, as measured by the Counselor 12-Step Attitudes and Beliefs Scale
Time Frame: 0, 1, 6 months
Counselor attitudes and beliefs about 12-step recovery and self-help approaches as measured by the Counselor 12-step Attitudes and Beliefs Scale (C-TAB) which queries about current 12-step referral practices, attitudes and beliefs about 12-step recovery and self-help approaches in general, strategies used to assist clients in engaging in the 12-step fellowship, and level of agreement with specific statements about 12-step groups
0, 1, 6 months
Change in counselor 12-step knowledge from baseline, as measured by the Counselor Core Elements of 12-step Knowledge Inventory
Time Frame: 0, 1, 6 months
Counselor knowledge about 12-step concepts as measured by the Counselor Core Elements of 12-step Knowledge Inventory (C-CETSKI), which focuses on the five toolkit content areas
0, 1, 6 months
Change in counselor feasibility and sustainability of the toolkit from baseline, as measured by a bi-weekly web-based calendar
Time Frame: 0, 1, 6 months
Feasibility and short-term sustainability will be measured via a web-based calendar which measures the type and frequency of the 12-step topics and toolkit materials counselors have used
0, 1, 6 months
Change in client involvement in 12-step activities from baseline, as measured by the Patient AA Attendance and Involvement Scale
Time Frame: 0, 2, 4, 12, 24 weeks
Number of 12-step meetings attended and engagement in other 12-step activities as measured by the Patient AA Attendance and Involvement Scale (PAIS) which assesses 12-step recovery activities
0, 2, 4, 12, 24 weeks
Change in client substance use from baseline, as measured by the Substance Use Inventory
Time Frame: 0, 2, 4, 12, 24 weeks
Self-reported alcohol and drug use as measured by the Substance Use Inventory (SUI), which is a modification of the Time-Line Follow-back Method in which a rater elicits frequency (in days) of consumption of alcohol and other illicit drugs as well as an estimate of average intensity of use
0, 2, 4, 12, 24 weeks

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.
Treatment Research Institute

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: Kimberly C Kirby, PhD, Treatment Research Institute

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

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.
March 1, 2011

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.
April 1, 2015

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.
April 1, 2015

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).
December 15, 2014

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.
January 6, 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.
January 7, 2015

Study Record Updates

Last Update Posted (Actual)

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.
March 28, 2023

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.
March 27, 2023

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.
March 1, 2023

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.
  • 0905
  • R01AA017867 (U.S. NIH Grant/Contract)

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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