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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02333357
Other study ID # 0905
Secondary ID R01AA017867
Status Completed
Phase N/A
First received
Last updated
Start date March 2011
Est. completion date April 2015

Study information

Verified date March 2023
Source Public Health Management Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3483
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
Treatment as Usual
Treatment as Usual is defined as five standard 12-step facilitation group sessions as counselors would normally conduct with their clients.

Locations

Country Name City State
United States Phoenix House Brooklyn New York
United States Genesis Counseling Centers Camden New Jersey
United States Eagleville Hospital Eagleville Pennsylvania
United States Livengrin Foundation Levittown Pennsylvania
United States Gaudenzia Inc. Philadelphia Pennsylvania
United States Penn Presbyterian Philadelphia Pennsylvania
United States Rehab After Work Philadelphia Pennsylvania
United States Self-Help Movement Philadelphia Pennsylvania
United States Sobreity Through Outpatient Philadelphia Pennsylvania
United States The Kirkbride Center Philadelphia Pennsylvania
United States The Wedge Recovery Centers Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Treatment Research Institute National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 0, 1, 6 months
Primary 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 0, 1, 6 months
Secondary 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 0, 1, 6 months
Secondary 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 0, 1, 6 months
Secondary 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 0, 1, 6 months
Secondary 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 0, 1, 6 months
Secondary 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 0, 2, 4, 12, 24 weeks
Secondary 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 0, 2, 4, 12, 24 weeks
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