1.       Purpose and Rational……1 

      1.1.                       Introduction to the Consumer-Operated Service Program 
               Multi-site Research Initiative
1.2                   Background
1.3         Study Objectives
1.3.1      Primary Objectives
1.3.2      Secondary Objectives   

2.       Overview of the Project…… 2   

       2.1                   Study Design
2.2                   Administration  of the COSP Multisite Research Initiative
2.2.1.      Steering Committee
2.2.2.           Coordinating Center
2.2.3.           CMHS Federal Team
2.2.4.     Consumer Advisory Panel   

3.       COSP Program Models……3 

        3.1.           Services Provided by Consumer-Operated Services
3.2.           Consumer Run Drop-In Centers
3.3.           Peer Support Programs
3.4.           Education and Advocacy Programs
3.5.           Common Ingredients of COSPs   

4.       Research Questions and Hypotheses…… 4   

       4.1                   Logic Model
4.2                   Multi-Site Study Research Questions and Hypotheses
4.2.1              Research Question 1
4.2.2              Research Question 2
4.2.2.1          Overview of CPPOA Model"
4.2.2.2         Approaches to CPPOA
4.3                   Hypotheses
4.3.1.           Short Term/Intermediate Outcomes
4.3.2.           Long Term Consumer Outcomes
4.3.3.           Research Hypotheses Related to Procedures and Costs 

5.       Multi-Site Research Design and Study Procedures…...5   

       5.1                           Identification of Target Population
5.1.1                Exclusion and Inclusion Criteria
5.1.1.1              COS Involvement
5.1.1.2            TMHS Involvement
5.1.1.3            TMHS Diagnosis
5.1.1.3.1         Recording Diagnosis for Data Repository
5.1.2                     Screening for Exclusion and Inclusion Criteria
5.2                       Data Collection
5.2.1                    Mode of Data Collection
5.2.2                    Data Collection Schedule
5.2.2.1              Data Collection Window
5.2.3                    Randomization Procedures
5.3                          Issues around Recruitment and Induction into the Study
5.3.1                    Recruitment Materials and Procedures and Demand Characteristics
5.3.2                    Guardianship
5.3.3                    Common Induction and Sampling Procedures
5.4                          Miscellaneous Issues
5.4.1                    Intention to serve analysis|
5.4.2                    Reviewing Informed Consents after Baseline
5.4.3                    Position of Site Specific Measures in the Common Protocol
5.4.4                    Tracking of Participants
5.4.5                    Confidentiality Certificate
5.4.6                    Pledge of Confidentiality
5.4.7                    Interviewer Observation Rating at End of Each Interview   

6           Cross-Site Analysis Plan…… 6

       6.1                 Overview of Planned Cross-Site Comparisons
6.2                   Multi-site research Issues
6.3               Data Quality Assessment
6.3.1            Development of Measures
6.4               Analyses Using Baseline Data
6.4.1            Initial Methodological and Descriptive Analyses
6.4.2            Preparing Project Level data for Inclusion in Analysis
6.4.3            Methodological Analyses of COSP/FACIT Scales
6.4.4            Descriptive Analyses of COSPs participating in the study
6.4.5            Clustering
6.4.6            Descriptive Summary of Participant Characteristics by Cluster
6.5               Approach to Longitudinal, Multi-Level, Cross-Site Analysis
6.6                   Statistical Modeling Approaches
6.6.1            Preliminary Regression-based Approaches
6.6.2            Power, Statistical Tests, Effect Size
6.6.3            Hierarchical Linear Models and Longitudinal Techniques
6.7               Potential Problems and Issues
6.7.1            Differential loss to follow-up
6.7.2            Procedures, Programs and Types of Program
6.8                   Integrating Cost Data
6.9                   Further Analysis and Planning

7           Assessing Consumer Operated Services…… 7 

       7.1               Introduction
7.2               Background
7.3               Fidelity and Implementation Assessments
7.4               Basic research Questions
7.5               Development Process
7.6               Proposed Draft Instrument   

8           Site Visits…… 8

        8.1               Purpose
        8.2               Timing
        8.3               Organization
        8.4               Traditional Mental Health Context
        8.5               Site Visit Reports

9           Consumer Data Collection and Treatment Documentation...  9

        9.1               Common Protocol 
        9.2               Domains
        9.3               Origins of the Instruments used in the Common Protocol
        9.4               Reference
             Exhibit 9.1
        9.5               Pilot Testing of Common Protocol
        9.6               Training of Interviewers
             Exhibit 9.5

10       Cost Study… 10  

10.1        Overview and History
10.2        Description of Track 1
10.3        Description of Track 2
10.4        Pilot Testing of Track 1/Track 2 Approaches

 11       Data Collection Methods and   Processes… 11  

        11.1            Overview
        11.2            Data Management Operations and Procedures

12       Quality Assurance Procedures in the COSP Multisite Study...  12 ...  12

12.1            Human Subjects Protections
12.2            Study Site Field Readiness
12.3            Study Site Data Collection Progress
12.4            Data Repository Protection and Error Reduction Efforts
12.5            Study Site Interview Standardization