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Recovery Roadmap Phase II Small Business Innovation Research Grant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02707367
Recruitment Status : Recruiting
First Posted : March 14, 2016
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Center for Social Innovation, Massachusetts

Brief Summary:
Recovery Roadmap: A Collaborative Multimedia Tool for Person-Centered Recovery Planning is a highly interactive web-based tool that provides guidance for providers and people in recovery, and promotes widespread implementation of Person-Centered Recovery Planning (PCRP). The Recovery Roadmap prototype was developed and tested by the Center for Social Innovation (C4), in partnership with Yale University's Program for Recovery and Community Health (PRCH), under a Phase I Small Business Innovative Research (SBIR) grant funded by the National Institute of Mental Health (NIMH) (1R43MH100712). Phase II will refine the prototype Roadmap to streamline content, provide additional handouts and exercises for providers and clients to complete together, expand the audio/video vignettes and case studies, and add interactive online coaching and support for providers. Phase II also involves a robust evaluation of the Roadmap, using a quasi-experimental design in a fully powered trial. Approximately 26 community-based mental health programs will be randomized into Recovery Roadmap (RR) or Illness Management and Recovery (IMR) conditions [in New York study sites, this practice is referred to as Wellness Self-Management (WSM)]. Participants will include both providers and clients, and data will include one pre-test and three post-tests with providers and clients, interviews with providers and administrators, network analytics, and administrative client data. This phase will culminate with the dissemination of findings and preparation for Phase III commercialization.

Condition or disease Intervention/treatment Phase
Mental Disorders Behavior Disorders Behavioral: Recovery Roadmap (RR) Behavioral: Illness Management and Recovery (IMR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Recovery Roadmap Phase II: A Collaborative Multimedia Tool for Person-Centered Recovery Planning
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: Recovery Roadmap (RR)
Participants from programs randomized to the RR condition will receive 6-month access to the Recovery Roadmap online tool.
Behavioral: Recovery Roadmap (RR)

A web-based tool that provides guidance for implementing Person-Centered Recovery Planning. Participants in the RR intervention will use the tool in Year 2, Quarter 1 (Y2Q1), Y2Q2, and Y2Q3. There are 3 components:

  1. Online module for service providers: A self-paced online module with interactive exercises, audio/video case studies, self-assessment, handouts, and collaborative materials designed for use with clients.
  2. Online module for people in recovery: A self-paced online module with interactive exercises, case studies, self-assessment, informational handouts, and collaborative materials to be completed with providers.
  3. Coaching & Support Center: A multimedia resource for providers with online coaching, a community of practice, and a resource library.

Active Comparator: Illness Management and Recovery (IMR)
Participants from programs randomized to the IMR condition will receive Illness Management and Recovery (IMR) mental health counseling practices.
Behavioral: Illness Management and Recovery (IMR)
IMR is an established evidence-based practice that helps people set meaningful goals for themselves, acquire information and skills to develop more mastery over their psychiatric illness, and make progress towards their own personal recovery. For this study, the IMR intervention will arise from established use of the intervention in enrolled programs.




Primary Outcome Measures :
  1. Person-Centered Care Questionnaire [ Time Frame: Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up) ]
    Change in PCRP knowledge and skills using the Person-Centered Care Questionnaire (Provider Version) for providers and the Person-Centered Care Questionnaire (Person in Recovery (PIR) Version) for clients (Tondora & Miller, 2009). The provider and client/PIR versions allow providers and clients/PIR to respond to slightly different items, but each study participant will have one reported PCCQ value at each time point.


Secondary Outcome Measures :
  1. Recovery Knowledge Inventory [ Time Frame: Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up) ]
    Change in provider participant knowledge and attitude data on four domains: roles and responsibilities in recovery, non-linearity of the recovery process, roles of self definition and peers in recovery, and expectations regarding recovery (Bedregal et al., 2006).

  2. Recovery Markers Questionnaire [ Time Frame: Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up) ]
    Change in client progress toward recovery (Ridgeway & Press, 2004).

  3. Helping Relationship Inventory [ Time Frame: Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up) ]
    Change in the relationship between the provider and client using the Helping Relationship Inventory-Worker for providers and the Helping Relationship Inventory-Client for clients (Poulin & Young, 1997). Provider and client versions allow participants to respond to slightly different Helping Relationship Inventory (HRI) items, but each study participant will have one reported HRI value at each time point.


Other Outcome Measures:
  1. Change in Provider Online Sociometric Surveys [ Time Frame: Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention) ]
    Online Sociometric Surveys will contribute to a mixed methods approach of mapping provider social networks and social connectivity.

  2. Qualitative Change in Provider Social Connectivity [ Time Frame: Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention) ]
    Semi-structured qualitative interviews will contribute to a mixed methods approach of mapping provider social networks and social connectivity.

  3. Change in Provider Network Analytic Data [ Time Frame: Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention) ]
    Social network analytics will contribute to a mixed methods approach of mapping provider social networks and social connectivity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Clients:

  • Age of majority
  • Receipt of mental health services within the participating program;
  • Directly work with a provider participating in the study
  • The ability to participate in the activities as determined by the client's clinical team
  • Willing and able to engage in a six month PCRP intervention and participate in follow-up research activities (24 months total including follow up assessments).

Providers: Providers must meet the following inclusion criteria:

  • Age of majority
  • Directly work with clients willing to participate in the study;
  • Have access to and basic navigation skills for using the Internet (for online coaching
  • Work for a participating program
  • Have a willingness to engage in a six-month PCRP intervention and participate in follow-up research activities (24 months total).

Administrators: Inclusion criteria for administrators participating in key informant semi-structured interviews include:

  • Age of majority
  • Being administrator of a program participating in the study or umbrella organization
  • Have access to a computer to view tool components
  • Knowledge about the market for this type of product for use in adult mental health. The team will develop a screening tool for administrators to ensure they meet basic criteria for the study.

Exclusion Criteria:

Clients:

  • Non-English speakers
  • Clients who are unable to participate in study activities (per clinical team determination) and individuals who are unable to understand the informed consent process (per the Quiz of Understanding for Informed Consent) will be excluded from the study.

Providers:

  • Non-English speakers
  • Providers who have prior experience with RR tools will be excluded from the study.

Administrators:

• Non-English speakers


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707367


Contacts
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Contact: Kathleen Ferreira, Ph.D. 352-212-2616 kferreira@center4si.com
Contact: Avery Brien, MPP 781-467-6014 abrien@center4si.com

Locations
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United States, Massachusetts
Center for Social Innovation Recruiting
Needham, Massachusetts, United States, 02494
Contact: Kathleen Ferreira, Ph.D.         
Sponsors and Collaborators
Center for Social Innovation, Massachusetts
Yale University
Investigators
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Principal Investigator: Kathleen Ferreira, Ph.D. Center for Social Innovation
Principal Investigator: Janis Tondora, PsyD. Yale University Program for Recovery and Community Health

Publications:
Poulin J & Young T. Development of a helping relationship inventory for social work practice. Research on Social Work Practice 7: 463-489, 1997.
Ridgway P & Press A. Assessing the recovery-orientation of your mental health program: A user's guide for the Recovery-Enhancing Environment scale (REE) (version 1). Lawrence, Kansas: University of Kansas, School of Social Welfare, Office of Mental Health Training and Research. 2004.
Tondora J & Miller R. The PCCQ: Person-centered care questionnaire: A tool for supervision and quality monitoring. Yale Program for Recovery & Community Health: New Haven, CT. 2009.

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Responsible Party: Center for Social Innovation, Massachusetts
ClinicalTrials.gov Identifier: NCT02707367    
Other Study ID Numbers: 2R44MH100712-03 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Mental Disorders
Pathologic Processes