Alcohol AbuseNCT02333357
Multimedia Toolkits to Implement 12-Step Recovery Concepts in Group Counseling
A study testing Multimedia 12-Step Toolkit and Treatment as Usual in people with Alcohol Abuse and Drug Abuse, run by Treatment Research Institute at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Drug Abuse
- What is being tested?
- Multimedia 12-Step Toolkit and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,483 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2011to Apr 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Employed at a participating substance abuse treatment facility
- Provide treatment in a group format
- 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
Who cannot join
- 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
- Unable to provide valid informed consent
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Phoenix House
Brooklyn, New York, 11201
Genesis Counseling Centers
Camden, New Jersey, 08108
Eagleville Hospital
Eagleville, Pennsylvania, 19408
Livengrin Foundation
Levittown, Pennsylvania, 19020
Rehab After Work
Philadelphia, Pennsylvania, 19102
Penn Presbyterian
Philadelphia, Pennsylvania, 19104
Self-Help Movement
Philadelphia, Pennsylvania, 19116
Sobreity Through Outpatient
Philadelphia, Pennsylvania, 19132
The Kirkbride Center
Philadelphia, Pennsylvania, 19139
The Wedge Recovery Centers
Philadelphia, Pennsylvania, 19148
Gaudenzia Inc.
Philadelphia, Pennsylvania, 19382
About this study
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.
Read the 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.
- Conditions
- Alcohol Abuse, Drug Abuse
- Being tested
- Multimedia 12-Step Toolkit, Treatment as Usual
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia 12-Step ToolkitBehavioural
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.
Treatment as UsualBehavioural
Treatment as Usual is defined as five standard 12-step facilitation group sessions as counselors would normally conduct with their clients.
| Study group | Role | What they receive |
|---|---|---|
| Toolkit | Experimental | 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. Receives: Behavioral: Multimedia 12-Step Toolkit |
| Treatment as Usual | Active comparator | 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. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in counselor content adherence from baseline, as measured by the Group Observation Rating System
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
Measured: 0, 1, 6 months
Change in counselor therapeutic skillfulness from baseline, as measured by the Group Observation Rating System
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
Measured: 0, 1, 6 months
Secondary outcomes (6)
Change in counselor satisfaction from baseline, as measured by the Counselor Satisfaction Form
Counselor satisfaction with their group sessions as measured by the Counselor Satisfaction Form which assesses counselors' overall satisfaction with the five 12-step groups
Measured: 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
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
Measured: 0, 1, 6 months
Change in counselor 12-step knowledge from baseline, as measured by the Counselor Core Elements of 12-step Knowledge Inventory
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
Measured: 0, 1, 6 months
Change in counselor feasibility and sustainability of the toolkit from baseline, as measured by a bi-weekly web-based calendar
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
Measured: 0, 1, 6 months
Change in client involvement in 12-step activities from baseline, as measured by the Patient AA Attendance and Involvement Scale
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
Measured: 0, 2, 4, 12, 24 weeks
Change in client substance use from baseline, as measured by the Substance Use Inventory
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
Measured: 0, 2, 4, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startMar 2011
- Primary completionApr 2015
- Study completionApr 2015
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Kimberly C Kirby, PhD, Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333357
- Sponsor's protocol ID
- 0905
- Other IDs
- R01AA017867
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2014
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimedia Toolkits to Implement 12-Step Recovery Concepts in Group Counseling
- ClinicalTrials.gov ID
- NCT02333357
- Acronym / sponsor ID
- 0905
- Conditions
- Alcohol Abuse, Drug Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,483 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Mar 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Jan 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toolkit | Experimental | Behavioral: Multimedia 12-Step ToolkitCounselors 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. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualCounselors 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years of age
- Employed at a participating substance abuse treatment facility
- Provide treatment in a group format
- Over 18 years of age
- Attending an observed group of a participating counselor
Key exclusion criteria (4 listed)
- 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
- Unable to provide valid informed consent
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 |
|---|---|---|
| Multimedia 12-Step ToolkitThe 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. | Behavioural | Toolkit |
| Treatment as UsualTreatment as Usual is defined as five standard 12-step facilitation group sessions as counselors would normally conduct with their clients. | Behavioural | Treatment as Usual |
Primary outcome
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
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
6 secondary outcomes
Change in counselor satisfaction from baseline, as measured by the Counselor Satisfaction Form
Time frame: 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
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
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
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
Change in client substance use from baseline, as measured by the Substance Use Inventory
Time frame: 0, 2, 4, 12, 24 weeks
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 28 Mar 2023.
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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.
Kimberly C Kirby, PhD principal investigator
Treatment Research Institute
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia 12-Step Toolkit and Treatment as Usual in people with Alcohol Abuse and Drug Abuse, run by Treatment Research Institute at 11 sites 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 6 inclusion and 4 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 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?
Change in counselor content adherence from baseline, as measured by the Group Observation Rating System (time frame: 0, 1, 6 months). The study lists 2 primary outcomes in all. 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 28 Mar 2023.