Mental HealthNIMBLENCT05644756
Novel Methods for Implementing Measurement-Based Care for Youth in Low-resource Environments
A study testing IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II) in people with Mental Health, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study will visit 4 community mental health clinics in Washington state and work with clinic staff to find out if staff are regularly evaluating clinical outcomes using questionnaires (which is also called measurement-based care or MBC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aim 1: Co-create plans for optimizing Measurement Based Care (MBC) implementation for youth with comorbidities. Clinic staff/Therapists (N=180) across 6 CMHCs in Washington state.
- Aged 21+
- Working at a CMHC that is participating in the WA State CBT (Cognitive Behavioral Therapy) + Initiative.
- Aim 2: Compare MBC fidelity post IMPACT Center methods deployment (3-months and 6-months) versus pre-implementation. Clinic staff/Therapists (N=30) across 6 CMHCs in Washington.
- Must be aged 21+
- Working at a CMHC that is participating in the Washington State CBT (Cognitive Behavioral Therapy) + Initiative.
Who cannot join
- Aim 1: Clinic staff/Therapists: Unwilling to participate in study activities.
- Aim 2: Clinic staff/Therapists:
- Unwilling to respond to fidelity measure over REDCap
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMPACT Center Signature Project 1, "Novel Methods for Implementing Measurement-Based Care for Youth in Low-resource Environments", is Embedded Within IMPACT Center P50 Entitled: Optimizing Evidence-Based Practice Implementation for Clinical Impact: the IMPACT Center.
This study will visit 4 community mental health clinics in Washington state and work with clinic staff to find out if staff are regularly evaluating clinical outcomes using questionnaires (which is also called measurement-based care or MBC). The study team will partner with clinic staff to find out what makes using questionnaires difficult and then plan to improve the use of questionnaires. The study activities will include trainings, interviews, collaborative discussions, and interactive activities.
Read the detailed description
Rapid Ethnographic Assessment (REA). REA will be conducted over 2-day site visits at each clinic, following a kickoff training on the principles of MBC. This team will conduct ethnographic observations on both days, using primarily unobtrusive techniques on Day 1, documenting observations of activities (e.g., clinician documentation), interactions (e.g., client check in), and events (e.g., staff meeting) using written and audio-recorded field notes. The investigators will interview staff for responses to the "example" question (for instance, "Could you show me how you use MBC in your work and describe what you are doing?") described above. The investigators expect up to 30 interviews per clinic: 30-45 minutes for therapists, 15 minutes for staff. The investigators will synthesize learnings from observations, interviews, and surveys in a debriefing session, using notes to generate a list of unique barriers. Day 2 will be focused observations of therapists shadowed by team members to document, track, and note the duration and location of activities, guided by barriers identified in the evidence review and Day 1 learnings. The investigators will conduct semi-structured, focused interviews based on Day 1 learnings, with therapists (therapists, supervisors, psychiatrists) and staff (up to 30). Day 2 interviews will be longer (15-30 minutes), audio recorded.
Design Kits. To complement REA and collect real-time data from therapists and youth, at the end of site visits, the investigators will leave design kit materials including disposable cameras, journals, pens and prompts to use to describe using MBC by taking pictures, make diary entries, draw maps, and record images. The investigators will ask therapists (5-8 per clinic) to participate.
Barrier Prioritization. The investigators will engage 5-8 therapists and/or staff in the prioritization activity for a 2-hour facilitated group activity. The activity will occur in-person (Site Visit 2) but could be delivered virtually if needed. Barriers identified through the rapid evidence review, rapid ethnographic assessment, and design kits (50+ expected) will be prioritized using a participant-engaged method.
Causal Pathway Diagramming. For each clinic, the investigators will develop Causal Pathway Diagrams (CPDs) for the top 3 prioritized barriers. The goal is to assess how well each implementation strategy is matched to a prioritized barrier, based on its mechanism of action, and to clarify the causal chain of events that must take place to achieve MBC fidelity.
Focus Groups to Improve IMPACT methods. The investigators will engage partners in a semi-structured focus group to capture their experience engaging in all IMPACT Center methods in the 3 site visits to inform further toolkit refinement. A facilitator not previously engaged in any of the activities will conduct a 60-minute focus group to solicit reactions to all aspects of IMPACT's methods, including the steps and personnel requirements of each method, and their output (e.g., prioritized barriers; utility of the information captured in the CPDs).
AIM 2: Compare MBC fidelity post IMPACT Center methods deployment versus historical controls.
The clinician self-report measure is a simple, quick, and homegrown self-report tool based upon the Collect, Share, Act conceptualization of MBC fidelity. The creation of this survey was guided by a need for something brief and pragmatic, and no self-report measures to our knowledge are (1) brief, (2) pragmatic, and (3) assess fidelity to the three main components of MBC. The survey asks clinicians to report (1) their approximate youth caseload in the last 6 months, and the percentage of youth patients with whom they have (2) collected data at least every two sessions, (3) shared data over the treatment course, and (4) acted on these processes to change the direction of treatment. Clinicians will complete this survey over REDCap. The study team will assess the internal reliability, concurrent validity, and convergent validity of the measure once data collection ends [41]. A copy of this measure is available from the first author.
The study will will present descriptive statistics to describe MBC fidelity at each of the three time points. The study will use a repeated measures analysis of variance to analyze whether fidelity to components of MBC changed from baseline (6 months after enrollment) to 3 months after active implementation, and finally 6 months after implementation.
- Conditions
- Mental Health
- Being tested
- IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II)
- Keywords
- Youth Mental Health, Improving Measurement-based Care, Community Mental Health Centers, Implementation Science
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II)Behavioural
IMPACT Center developed two methods for identifying determinants that involved providers, staff, and youth at community mental health centers in site visit 1: Rapid Ethnographic Assessment, Design Probes. Then, practice partners engage in a facilitated group activity to rate the criticality, chronicity, and ubiquity of the list of determinants in Site Visit 2. Finally, practice partners engage in a third site visit where they create Causal Pathway Diagrams that allow them to match strategies to prioritize determinants and create Implementation Plans.
| Study group | Role | What they receive |
|---|---|---|
| Measurement Based Care Implementation | Other | Four community mental health clinics located in Washington state will receive trainings on how to implement Measurement Based Care (MBC) in their clinics. We are creating implementation plans to improve therapists' use of measurement-based care. Receives: Behavioral: IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Youth Clients Provided Outcome Questionnaires
Aim 2 Therapists will report on the number of clinical outcome questionnaires administered to youth clients (the total number of outcome questionnaires per client used) before and after engaging in our researcher-driven implementation process.
Measured: We will assess at 6 (pre-implementation), 9 (3 months post-implementation), and 12 (6 months post-implementation) months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start25 Oct 2022
- Primary completion31 Jul 2024
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Brown University
- Responsible party
- Sponsor
- Investigators
- Ruben G Martinez, PhD, Study director, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644756
- Sponsor's protocol ID
- 1943932-2
- Other IDs
- P50MH126219
- Acronym
- NIMBLE
- Status last verified
- Jun 2025
- First submitted
- 18 Nov 2022
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez RG, Weiner BJ, Meza RD, Dorsey S, Palazzo LG, Matson A, Bain C, Mettert KD, Pullmann MD, Lewis CC. Study protocol: Novel Methods for Implementing Measurement-Based Care with youth in Low-Resource Environments (NIMBLE). Implement Sci Commun. 2023 Nov 28;4(1):152. doi: 10.1186/s43058-023-00526-z.
PubMed 38017522Martinez RG, Cramer ER, Norris LA, Matson A, Lang C, Henrikson NB, Blasi PR, Palazzo LG, Hoopes AJ, Dorsey S, Weiner BJ. Short Report: Comparison of three methods for identifying implementation determinants to measurement-based care. Res Sq [Preprint]. 2025 Nov 19:rs.3.rs-7973723. doi: 10.21203/rs.3.rs-7973723/v1.
PubMed 41333394
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT Center Signature Project 1, "Novel Methods for Implementing Measurement-Based Care for Youth in Low-resource Environments", is Embedded Within IMPACT Center P50 Entitled: Optimizing Evidence-Based Practice Implementation for Clinical Impact: the IMPACT Center.
- ClinicalTrials.gov ID
- NCT05644756
- Acronym / sponsor ID
- NIMBLE / 1943932-2
- Conditions
- Mental Health
- Keywords
- Youth Mental Health, Improving Measurement-based Care, Community Mental Health Centers, Implementation Science
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Brown University
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Posted 2 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will visit 4 community mental health clinics in Washington state and work with clinic staff to find out if staff are regularly evaluating clinical outcomes using questionnaires (which is also called measurement-based care or MBC). The study team will partner with clinic staff to find out what makes using questionnaires difficult and then plan to improve the use of questionnaires. The study activities will include trainings, interviews, collaborative discussions, and interactive activities.
Detailed description
Rapid Ethnographic Assessment (REA). REA will be conducted over 2-day site visits at each clinic, following a kickoff training on the principles of MBC. This team will conduct ethnographic observations on both days, using primarily unobtrusive techniques on Day 1, documenting observations of activities (e.g., clinician documentation), interactions (e.g., client check in), and events (e.g., staff meeting) using written and audio-recorded field notes. The investigators will interview staff for responses to the "example" question (for instance, "Could you show me how you use MBC in your work and describe what you are doing?") described above. The investigators expect up to 30 interviews per clinic: 30-45 minutes for therapists, 15 minutes for staff. The investigators will synthesize learnings from observations, interviews, and surveys in a debriefing session, using notes to generate a list of unique barriers. Day 2 will be focused observations of therapists shadowed by team members to document, track, and note the duration and location of activities, guided by barriers identified in the evidence review and Day 1 learnings. The investigators will conduct semi-structured, focused interviews based on Day 1 learnings, with therapists (therapists, supervisors, psychiatrists) and staff (up to 30). Day 2 interviews will be longer (15-30 minutes), audio recorded.
Design Kits. To complement REA and collect real-time data from therapists and youth, at the end of site visits, the investigators will leave design kit materials including disposable cameras, journals, pens and prompts to use to describe using MBC by taking pictures, make diary entries, draw maps, and record images. The investigators will ask therapists (5-8 per clinic) to participate.
Barrier Prioritization. The investigators will engage 5-8 therapists and/or staff in the prioritization activity for a 2-hour facilitated group activity. The activity will occur in-person (Site Visit 2) but could be delivered virtually if needed. Barriers identified through the rapid evidence review, rapid ethnographic assessment, and design kits (50+ expected) will be prioritized using a participant-engaged method.
Causal Pathway Diagramming. For each clinic, the investigators will develop Causal Pathway Diagrams (CPDs) for the top 3 prioritized barriers. The goal is to assess how well each implementation strategy is matched to a prioritized barrier, based on its mechanism of action, and to clarify the causal chain of events that must take place to achieve MBC fidelity.
Focus Groups to Improve IMPACT methods. The investigators will engage partners in a semi-structured focus group to capture their experience engaging in all IMPACT Center methods in the 3 site visits to inform further toolkit refinement. A facilitator not previously engaged in any of the activities will conduct a 60-minute focus group to solicit reactions to all aspects of IMPACT's methods, including the steps and personnel requirements of each method, and their output (e.g., prioritized barriers; utility of the information captured in the CPDs).
AIM 2: Compare MBC fidelity post IMPACT Center methods deployment versus historical controls.
The clinician self-report measure is a simple, quick, and homegrown self-report tool based upon the Collect, Share, Act conceptualization of MBC fidelity. The creation of this survey was guided by a need for something brief and pragmatic, and no self-report measures to our knowledge are (1) brief, (2) pragmatic, and (3) assess fidelity to the three main components of MBC. The survey asks clinicians to report (1) their approximate youth caseload in the last 6 months, and the percentage of youth patients with whom they have (2) collected data at least every two sessions, (3) shared data over the treatment course, and (4) acted on these processes to change the direction of treatment. Clinicians will complete this survey over REDCap. The study team will assess the internal reliability, concurrent validity, and convergent validity of the measure once data collection ends [41]. A copy of this measure is available from the first author.
The study will will present descriptive statistics to describe MBC fidelity at each of the three time points. The study will use a repeated measures analysis of variance to analyze whether fidelity to components of MBC changed from baseline (6 months after enrollment) to 3 months after active implementation, and finally 6 months after implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement Based Care Implementation | Other | Behavioral: IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II)Four community mental health clinics located in Washington state will receive trainings on how to implement Measurement Based Care (MBC) in their clinics. We are creating implementation plans to improve therapists' use of measurement-based care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aim 1: Co-create plans for optimizing Measurement Based Care (MBC) implementation for youth with comorbidities. Clinic staff/Therapists (N=180) across 6 CMHCs in Washington state.
- Aged 21+
- Working at a CMHC that is participating in the WA State CBT (Cognitive Behavioral Therapy) + Initiative.
- Aim 2: Compare MBC fidelity post IMPACT Center methods deployment (3-months and 6-months) versus pre-implementation. Clinic staff/Therapists (N=30) across 6 CMHCs in Washington.
- Must be aged 21+
Key exclusion criteria (3 listed)
- Aim 1: Clinic staff/Therapists: Unwilling to participate in study activities.
- Aim 2: Clinic staff/Therapists:
- Unwilling to respond to fidelity measure over REDCap
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 |
|---|---|---|
| IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II)IMPACT Center developed two methods for identifying determinants that involved providers, staff, and youth at community mental health centers in site visit 1: Rapid Ethnographic Assessment, Design Probes. Then, practice partners engage in a facilitated group activity to rate the criticality, chronicity, and ubiquity of the list of determinants in Site Visit 2. Finally, practice partners engage in a third site visit where they create Causal Pathway Diagrams that allow them to match strategies to prioritize determinants and create Implementation Plans. | Behavioural | Measurement Based Care Implementation |
Primary outcome
Number of Youth Clients Provided Outcome Questionnaires
Time frame: We will assess at 6 (pre-implementation), 9 (3 months post-implementation), and 12 (6 months post-implementation) months after enrollment.
Aim 2 Therapists will report on the number of clinical outcome questionnaires administered to youth clients (the total number of outcome questionnaires per client used) before and after engaging in our researcher-driven implementation process.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38017522Martinez RG, Weiner BJ, Meza RD, Dorsey S, Palazzo LG, Matson A, Bain C, Mettert KD, Pullmann MD, Lewis CC. Study protocol: Novel Methods for Implementing Measurement-Based Care with youth in Low-Resource Environments (NIMBLE). Implement Sci Commun. 2023 Nov 28;4(1):152. doi: 10.1186/s43058-023-00526-z.
- Derived from this study: PubMed 41333394Martinez RG, Cramer ER, Norris LA, Matson A, Lang C, Henrikson NB, Blasi PR, Palazzo LG, Hoopes AJ, Dorsey S, Weiner BJ. Short Report: Comparison of three methods for identifying implementation determinants to measurement-based care. Res Sq [Preprint]. 2025 Nov 19:rs.3.rs-7973723. doi: 10.21203/rs.3.rs-7973723/v1.
- 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.
Ruben G Martinez, PhD study director
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II) in people with Mental Health, run by Kaiser Permanente 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Youth Clients Provided Outcome Questionnaires (time frame: We will assess at 6 (pre-implementation), 9 (3 months post-implementation), and 12 (6 months post-implementation) months after enrollment.). 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 NCT05644756, which also lists 2 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 2 Jul 2025.