NCT02333357

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,483

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

4.1 years

First QC Date

December 15, 2014

Last Update Submit

March 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Change in counselor satisfaction from baseline, as measured by the Counselor Satisfaction Form

    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

    0, 1, 6 months

  • Change in counselor 12-step knowledge from baseline, as measured by the Counselor Core Elements of 12-step Knowledge Inventory

    0, 1, 6 months

  • Change in counselor feasibility and sustainability of the toolkit from baseline, as measured by a bi-weekly web-based calendar

    0, 1, 6 months

  • Change in client involvement in 12-step activities from baseline, as measured by the Patient AA Attendance and Involvement Scale

    0, 2, 4, 12, 24 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Treatment as Usual

Interventions

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.

Toolkit

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

Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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
  • \- Unable to provide valid informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Genesis Counseling Centers

Camden, New Jersey, 08108, United States

Location

Phoenix House

Brooklyn, New York, 11201, United States

Location

Eagleville Hospital

Eagleville, Pennsylvania, 19408, United States

Location

Livengrin Foundation

Levittown, Pennsylvania, 19020, United States

Location

Rehab After Work

Philadelphia, Pennsylvania, 19102, United States

Location

Penn Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

Self-Help Movement

Philadelphia, Pennsylvania, 19116, United States

Location

Sobreity Through Outpatient

Philadelphia, Pennsylvania, 19132, United States

Location

The Kirkbride Center

Philadelphia, Pennsylvania, 19139, United States

Location

The Wedge Recovery Centers

Philadelphia, Pennsylvania, 19148, United States

Location

Gaudenzia Inc.

Philadelphia, Pennsylvania, 19382, United States

Location

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kimberly C Kirby, PhD

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2014

First Posted

January 7, 2015

Study Start

March 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations