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AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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)
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.

United States1 site
  • KPWHRI

    Seattle, Washington, 98101

Other trials in United States

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 groups in NCT05644756
Study groupRoleWhat they receive
Measurement Based Care ImplementationOtherFour 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.

  1. 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.

  1. First posted9 Dec 2022
  2. Study start25 Oct 2022
  3. Primary completion31 Jul 2024
  4. Study completion31 Aug 2025 (estimated)

Resources

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)
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
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 38017522
  • Martinez 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

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.

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