Clinical trial NCT05799794: Optimizing Implementation Coaching to Support Successful EBP Delivery
Official title: Optimizing Implementation Coaching to Improve Treatment Quality and Client Outcomes in Community Mental Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression
Mental Health Issue
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-04-05
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aim 1a: The investigators will utilize Ideation to develop coaching strategies with supervisors.

Aim 1b: The investigators will conduct an online experimental vignette study to gather preliminary evidence for how effectively different strategies emerging from Aim 1 impact our theorized mechanism (Implementation Climate-e.g., CBT use expected).

Aim 1 activities are not part of the clinical trial (which starts with Aim 2 activities).

Aim 2: The investigators will utilize a 2-arm randomized controlled trial to compare outcomes for anxiety, depression, PTSD, and behavioral problems for the group in the Implementation Coaching strategy optimized in Aim 1 and the Initiative's standard/as usual implementation. The groups will engage in the implementation support for 6 months and will complete a survey before and after the implementation support is terminated.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project engages community mental health center (CMHC) clinical supervisors in the development and examination of an optimized coaching strategy for psychotherapists utilizing Cognitive Behavioral Therapy (CBT) in Washington State. The optimized coaching strategy has the potential to enhance the adoption and fidelity of evidence-based practice (EBP).

Detailed description: The Washington State EBP Initiative provides clinical training and consultation for Cognitive Behavioral Therapy (CBT) and some basic organizational support; however, consistent with the literature, community mental health centers (CMHCs) often need more to successfully implement CBT. To accelerate treatment quality and clinical outcomes for youth, CMHCs need practical strategies for "successfully implementing, sustaining, and improving" EBPs that can be tailored to fit their specific context. These strategies will have the greatest impact if designed and delivered by CMHC practice community members who have CMHC-specific EBP implementation experience and expertise.

Implementation facilitation, a multifaceted, dynamic strategy of interactive problem-solving and support, improves adoption and fidelity of interventions. Implementation facilitation may be a promising strategy for CMHCs, but the resources and demands of traditional facilitation may present challenges for CMHCs. Motivated by global mental health frugal innovations work, the Principal Investigator piloted a modified facilitation approach for CMHCs, Implementation Coaching (hereafter "Coaching"), delivered to CMHCs participating in the Initiative. Coaching involved 4, group-based, virtual meetings with CMHC supervisors, who are frontline leaders in CMHCs. The investigator led coaching, supporting supervisors in developing workplans for CBT implementation in their CMHCs across 3 implementation phases. Coaching recommends a limited set of implementation strategies in each phase (e.g., Implementation phase: local technical assistance) that address known, prioritized determinants. Supervisors are supported in tailoring strategies for their CMHCs. In the pilot, CMHCs that received Coaching had clinicians that engaged in CBT delivery earlier and with more youth. Qualitative interviews suggested that supervisors were engaged and found Coaching acceptable and feasible. Based on the pilots' success, Project 2 will engage CMHC supervisors in: a) co-designing an optimized version of Coaching, and b) leading Coaching for other supervisors to optimize CBT implementation in their CMHCs.

In this exploratory research project, the Investigators' goal is to extend a pilot study that included the development and implementation of Implementation Coaching (hereafter "Coaching") within the Washington State EBP Initiative. In the pilot, the Coaching involved 4, group-based, virtual meetings with CMHC supervisors, who are frontline leaders in CMHCs. The results of the pilot indicated that Coaching was acceptable and feasible. In the current study, in collaboration with CMHC supervisors, investigators aim to optimize and test the effectiveness of Coaching for improving CBT fidelity and youth outcomes for four common conditions in CMHCs. The hypothesized mechanism through which Coaching operates is implementation climate or the degree to which an organization expects, supports, and rewards an innovation. Investigators expect that Coaching can be most effective in supporting CMHCs' high-quality EBP implementation if optimized with the practice community (supervisors) for the goals of limited resource use, fit with CMHC workflow, and wider reach. Coaching reach can be improved by moving beyond delivery by University-based personnel. In the Initiative, peer CMHC supervisors with CBT experience and expertise already co-lead CBT clinical training.

The study includes the following aims: Aim 1a) Collaborating with CMHCs, investigators will identify and convene purposively sampled groups of supervisors for diverse perspectives and demographics (e.g., ethnically diverse supervisors/clientele; urban/rural) during 2 one-day, in-person Ideation workshops; Aim 1b) Up to 150 clinicians will be recruited through the Initiative listserv and CBT+ training (for clinicians who recently completed their training) to participate in an online study in which clinicians will be randomized to read up to 6 vignettes that describe different strategies developed in the ideation phase and complete a survey with relevant subscale/s of implementation climate (EBP use is expected, supported and rewarded); Aim 2) Clinicians will be randomly assigned to receive standard implementation support or standard implementation support plus Coaching by trained supervisors.

Eligibility criteria: Inclusion Criteria:

* Supervisors in aim 1a and clinicians/supervisors in aim 2 must

  * be employed in CMHCs whose leadership has agreed to participate in the study
  * have participated or be participating in the Initiative.
  * Clinicians in aim 1b do not need to be employed in a CMHC whose leadership has agreed to participate in the study.

Exclusion Criteria:

• There is no exclusion criteria for supervisors in Aim 1a or clinicians in 1b.

* Supervisors who participate in Aim 1 will be excluded from participating in Aim 2 as recipients of Implementation Coaching.
* Supervisor coaches will be recruited from the supervisors that participated in Aim 2. There is no exclusion criteria for clinicians in Aim 2.

Primary outcomes:
measure: CBT Fidelity
timeFrame: through study completion, an average of 7 months
Secondary outcomes:
measure: Externalizing Behavior Symptoms
timeFrame: through study completion, an average of 7 months
measure: Posttraumatic Stress Symptoms
timeFrame: through study completion, an average of 7 months
measure: Depressive Symptoms
timeFrame: through study completion, an average of 7 months
measure: Anxiety Symptoms
timeFrame: through study completion, an average of 7 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: WA EBP Initiative
state: Washington
Study officials:
affiliation: University of Washington
name: Shannon Dorsey, PhD
role: PRINCIPAL_INVESTIGATOR
References: