Mental DisordersNCT02707367
Recovery Roadmap Phase II Small Business Innovation Research Grant
A study testing Recovery Roadmap (RR) Wave 1 and Recovery Roadmap (RR) Wave 2 in people with Mental Disorders and Behavior Disorders, run by Center for Social Innovation, Massachusetts at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders, Behavior Disorders
- What is being tested?
- Recovery Roadmap (RR) Wave 1 and Recovery Roadmap (RR) Wave 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Social Innovation
Needham, Massachusetts, 02494
About this study
Official title: Recovery Roadmap Phase II: A Collaborative Multimedia Tool for Person-Centered Recovery Planning
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 refined 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 involved a robust evaluation of the Roadmap, using a quasi-experimental design in a fully powered trial. Approximately 30 practitioners and 90 clients (two to three clients per practitioner) were recruited from a total of five Community Support Programs in Connecticut. The programs were randomly selected into one of two intervention waves (Wave 1 and Wave 2). Survey data for Wave 1 included a total of four surveys: a pre-observation period, post-observation/pre-intervention, a midpoint survey (after completion of online curriculum), and a post survey (after completion of the entire intervention, including coaching calls). Surveys for the Wave 2 study participants included a pre-intervention, midpoint, and post survey. Qualitative interviews were also completed with interviews with practitioners and and administrators/clinical supervisors in each agency. State level client administrative client data were also collected and analyzed. Data examined changes in knowledge related to PCRP, person centered planning practices, practitioner/client relationship, and overall feedback on the intervention. our team also conducted a social network analysis to examine any changes in the size and strength of their networks related to person centered planning before and after the intervention. This phase will culminate with the dissemination of findings and preparation for Phase III commercialization.
Read the detailed description
Person-Centered Recovery Planning (PCRP; also referred to as Patient-Centered Care Planning) is a field-tested intervention designed to maximize consumer choice and ownership of the treatment and recovery process. In Phase I of Recovery Roadmap: A Collaborative Multimedia Tool for Person-Centered Recovery Planning, the research team developed a prototype online tool to train providers and persons in recovery to understand and implement PCRP. The tool provided in-depth information and included interactive components (e.g., videos, fillable forms, case studies) to prepare users to partner effectively. The tool was pilot tested in two sites (one received the Recovery Roadmap only; the other received the tool plus a two-day in-person training) to obtain feedback about the Roadmap and determine its impact. The purpose of this Phase II SBIR study is to expand the Recovery Roadmap and conduct a fully powered study to determine the tool's effectiveness in training providers and supporting people in recovery in the PCRP process.
This proposed Phase II study design:
We propose a randomized stepped wedge design in which we will recruit a total of 30 practitioners and 90 persons in recovery (PIRs), 3-4 from each participating practitioner. Per the power analysis, 90 PIRs will have enough power to show statistical significance. We will:
- Randomize the sample into two intervention waves, Wave 1 and Wave 2.
- Do a T1 assessment with all practitioners and PIRs and then immediately begin the first 2-month component of Wave 1 Recovery Roadmap Intervention, i.e., the 5-unit, online PCRP curriculum, with both PIRs and practitioners (for Wave 1, T1 will be a Baseline assessment; for Wave 2, T1 will be a Pre-Baseline assessment). Total of 3 months, including assessment and completion of the curriculum, while Wave 2 completes an observation period.
- Do a T2 assessment (practitioners and PIRs) with both waves and launch the first component of intervention with Wave 2 (RR on-line training units only) while Wave 1 launches the second component of the RR intervention, i.e., practitioners (only) receiving 3 months of twice monthly coaching calls and an on-line Community of Practice. The series of web-based technical assistance (coaching) sessions are designed to reinforce PCRP key principles and practices as taught in the Recovery Roadmap and to optimize practitioners' use of/benefit from the web-based Community of Practice (COP). Wave 2 will have a total of 3 months, including its Baseline assessment and completion of the online curriculum. Wave 1 will have a total of 4 months, including the mid-point assessment for PIRs and practitioners and completion of coaching calls and COP for practitioners.
- Do a T3 Assessment (practitioners and PIRs). This will be, for Wave 1, a post-intervention assessment for PIRs and practitioners. For Wave 2, it will include a mid-point intervention assessment for PIRs and practitioners, with Wave 2 immediately beginning a second component of the intervention (3 months of twice monthly coaching calls and an online COP for practitioners). The series of web-based technical assistance sessions are designed to reinforce PCRP key principles and practices as taught in the Recovery Roadmap and to optimize practitioners' use of/benefit from the web-based Community of Practice. Wave 1 will have a total of 3 months, including assessments and a 2-month observation period. Wave 2 will have a total of 4 months, including the mid-point assessment for PIRs and practitioners and completion of coaching calls and COP for practitioners.
- Do a T4 Assessment (practitioners and PIRs) after Wave 2 has completed the COP. This is post intervention for Wave 2 and follow-up for Wave 1.
Hypotheses (for Aims 1 and 2):
H1: Providers in the RR condition will show statistically significant improvements in PCRP knowledge, skills, and provider-client relationships.
H2: Clients served by providers in the RR condition will show statistically significant improvements in treatment engagement and progress toward goals.
H3: Providers with higher levels of connectivity with their peers online will report sustained PCRP practices, compared with those with lower connectivity.
- Conditions
- Mental Disorders, Behavior Disorders
- Being tested
- Recovery Roadmap (RR) Wave 1, Recovery Roadmap (RR) Wave 2
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Roadmap (RR) Wave 1Behavioural
A web-based tool that provides guidance for implementing Person-Centered Recovery Planning. There are 3 components:
- 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.
- 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.
- Coaching \& Support Center: A multimedia resource for providers with online coaching, a community of practice, and a resource library.
Recovery Roadmap (RR) Wave 2Behavioural
A web-based tool that provides guidance for implementing Person-Centered Recovery Planning. There are 3 components:
- 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.
- 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.
- Coaching \& Support Center: A multimedia resource for providers with online coaching, a community of practice, and a resource library.
| Study group | Role | What they receive |
|---|---|---|
| Recovery Roadmap (RR) Wave 1 | Experimental | All participants, in both Wave 1 and Wave 2, will act as their own comparator in a randomized stepped wedge design. Data collection in Wave 1 will include two pre-tests and two post-tests, building in an observation period that is not present in Wave 2. Receives: Behavioral: Recovery Roadmap (RR) Wave 1 |
| Recovery Roadmap (RR) Wave 2 | Experimental | All participants, in both Wave 1 and Wave 2, will act as their own comparator in a randomized stepped wedge design. Data collection in Wave 1 will include one pre-test and three post-tests. Receives: Behavioral: Recovery Roadmap (RR) Wave 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Person-Centered Care Questionnaire
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.
Measured: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
Secondary outcomes (3)
Recovery Knowledge Inventory
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).
Measured: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
Recovery Markers Questionnaire
Change in client progress toward recovery (Ridgeway \& Press, 2004).
Measured: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
Helping Relationship Inventory
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.
Measured: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study start1 Jun 2017
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Social Innovation, Massachusetts
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Kathleen Ferreira, Ph.D., Principal investigator, Center for Social InnovationJanis Tondora, PsyD., Principal investigator, Yale University Program for Recovery and Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707367
- Sponsor's protocol ID
- 2R44MH100712-03
- Status last verified
- Sep 2020
- First submitted
- 1 Mar 2016
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bedregal LE, O'Connell M, Davidson L. The Recovery Knowledge Inventory: assessment of mental health staff knowledge and attitudes about recovery. Psychiatr Rehabil J. 2006 Fall;30(2):96-103. doi: 10.2975/30.2006.96.103.
PubMed 17076052Poulin 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Roadmap Phase II: A Collaborative Multimedia Tool for Person-Centered Recovery Planning
- ClinicalTrials.gov ID
- NCT02707367
- Acronym / sponsor ID
- 2R44MH100712-03
- Conditions
- Mental Disorders, Behavior Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Center for Social Innovation, MassachusettsUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 14 Mar 2016 (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.
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 refined 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 involved a robust evaluation of the Roadmap, using a quasi-experimental design in a fully powered trial. Approximately 30 practitioners and 90 clients (two to three clients per practitioner) were recruited from a total of five Community Support Programs in Connecticut. The programs were randomly selected into one of two intervention waves (Wave 1 and Wave 2). Survey data for Wave 1 included a total of four surveys: a pre-observation period, post-observation/pre-intervention, a midpoint survey (after completion of online curriculum), and a post survey (after completion of the entire intervention, including coaching calls). Surveys for the Wave 2 study participants included a pre-intervention, midpoint, and post survey. Qualitative interviews were also completed with interviews with practitioners and and administrators/clinical supervisors in each agency. State level client administrative client data were also collected and analyzed. Data examined changes in knowledge related to PCRP, person centered planning practices, practitioner/client relationship, and overall feedback on the intervention. our team also conducted a social network analysis to examine any changes in the size and strength of their networks related to person centered planning before and after the intervention. This phase will culminate with the dissemination of findings and preparation for Phase III commercialization.
Detailed description
Person-Centered Recovery Planning (PCRP; also referred to as Patient-Centered Care Planning) is a field-tested intervention designed to maximize consumer choice and ownership of the treatment and recovery process. In Phase I of Recovery Roadmap: A Collaborative Multimedia Tool for Person-Centered Recovery Planning, the research team developed a prototype online tool to train providers and persons in recovery to understand and implement PCRP. The tool provided in-depth information and included interactive components (e.g., videos, fillable forms, case studies) to prepare users to partner effectively. The tool was pilot tested in two sites (one received the Recovery Roadmap only; the other received the tool plus a two-day in-person training) to obtain feedback about the Roadmap and determine its impact. The purpose of this Phase II SBIR study is to expand the Recovery Roadmap and conduct a fully powered study to determine the tool's effectiveness in training providers and supporting people in recovery in the PCRP process.
This proposed Phase II study design:
We propose a randomized stepped wedge design in which we will recruit a total of 30 practitioners and 90 persons in recovery (PIRs), 3-4 from each participating practitioner. Per the power analysis, 90 PIRs will have enough power to show statistical significance. We will:
- Randomize the sample into two intervention waves, Wave 1 and Wave 2.
- Do a T1 assessment with all practitioners and PIRs and then immediately begin the first 2-month component of Wave 1 Recovery Roadmap Intervention, i.e., the 5-unit, online PCRP curriculum, with both PIRs and practitioners (for Wave 1, T1 will be a Baseline assessment; for Wave 2, T1 will be a Pre-Baseline assessment). Total of 3 months, including assessment and completion of the curriculum, while Wave 2 completes an observation period.
- Do a T2 assessment (practitioners and PIRs) with both waves and launch the first component of intervention with Wave 2 (RR on-line training units only) while Wave 1 launches the second component of the RR intervention, i.e., practitioners (only) receiving 3 months of twice monthly coaching calls and an on-line Community of Practice. The series of web-based technical assistance (coaching) sessions are designed to reinforce PCRP key principles and practices as taught in the Recovery Roadmap and to optimize practitioners' use of/benefit from the web-based Community of Practice (COP). Wave 2 will have a total of 3 months, including its Baseline assessment and completion of the online curriculum. Wave 1 will have a total of 4 months, including the mid-point assessment for PIRs and practitioners and completion of coaching calls and COP for practitioners.
- Do a T3 Assessment (practitioners and PIRs). This will be, for Wave 1, a post-intervention assessment for PIRs and practitioners. For Wave 2, it will include a mid-point intervention assessment for PIRs and practitioners, with Wave 2 immediately beginning a second component of the intervention (3 months of twice monthly coaching calls and an online COP for practitioners). The series of web-based technical assistance sessions are designed to reinforce PCRP key principles and practices as taught in the Recovery Roadmap and to optimize practitioners' use of/benefit from the web-based Community of Practice. Wave 1 will have a total of 3 months, including assessments and a 2-month observation period. Wave 2 will have a total of 4 months, including the mid-point assessment for PIRs and practitioners and completion of coaching calls and COP for practitioners.
- Do a T4 Assessment (practitioners and PIRs) after Wave 2 has completed the COP. This is post intervention for Wave 2 and follow-up for Wave 1.
Hypotheses (for Aims 1 and 2):
H1: Providers in the RR condition will show statistically significant improvements in PCRP knowledge, skills, and provider-client relationships.
H2: Clients served by providers in the RR condition will show statistically significant improvements in treatment engagement and progress toward goals.
H3: Providers with higher levels of connectivity with their peers online will report sustained PCRP practices, compared with those with lower connectivity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery Roadmap (RR) Wave 1 | Experimental | Behavioral: Recovery Roadmap (RR) Wave 1All participants, in both Wave 1 and Wave 2, will act as their own comparator in a randomized stepped wedge design. Data collection in Wave 1 will include two pre-tests and two post-tests, building in an observation period that is not present in Wave 2. |
| Recovery Roadmap (RR) Wave 2 | Experimental | Behavioral: Recovery Roadmap (RR) Wave 2All participants, in both Wave 1 and Wave 2, will act as their own comparator in a randomized stepped wedge design. Data collection in Wave 1 will include one pre-test and three post-tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
- Non-English speakers
- Providers who have prior experience with RR tools will be excluded from the study.
- Non-English speakers
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 |
|---|---|---|
| Recovery Roadmap (RR) Wave 1A web-based tool that provides guidance for implementing Person-Centered Recovery Planning. 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. | Behavioural | Recovery Roadmap (RR) Wave 1 |
| Recovery Roadmap (RR) Wave 2A web-based tool that provides guidance for implementing Person-Centered Recovery Planning. 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. | Behavioural | Recovery Roadmap (RR) Wave 2 |
Primary outcome
Person-Centered Care Questionnaire
Time frame: PreBaseline (pre-observation), 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.
3 secondary outcomes
Recovery Knowledge Inventory
Time frame: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
Recovery Markers Questionnaire
Time frame: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
Helping Relationship Inventory
Time frame: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
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 1 Oct 2020.
- Background: PubMed 17076052Bedregal LE, O'Connell M, Davidson L. The Recovery Knowledge Inventory: assessment of mental health staff knowledge and attitudes about recovery. Psychiatr Rehabil J. 2006 Fall;30(2):96-103. doi: 10.2975/30.2006.96.103.
- BackgroundPoulin J & Young T. Development of a helping relationship inventory for social work practice. Research on Social Work Practice 7: 463-489, 1997.
- BackgroundRidgway 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.
- BackgroundTondora 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.
- Individual participant dataSharing planned: No
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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.
Kathleen Ferreira, Ph.D. principal investigator
Center for Social Innovation
Janis Tondora, PsyD. principal investigator
Yale University Program for Recovery and Community Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Roadmap (RR) Wave 1 and Recovery Roadmap (RR) Wave 2 in people with Mental Disorders and Behavior Disorders, run by Center for Social Innovation, Massachusetts at 1 site 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 17 inclusion and 8 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 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Person-Centered Care Questionnaire (time frame: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707367, which also lists 4 linked publications.
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 1 Oct 2020.