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The Implementation and Sustainment of Digital MBC in Youth Mental Health Services

Primary Purpose

Leadership, Behavioral Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leadership for Organization Change and Implementation (LOCI)
Leadership web-based seminars
Sponsored by
Boise State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Leadership focused on measuring LOCI, measurement based care, evidence-based practice, behavioral health, youth mental health, leadership, implementation science

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Participants for this project will fall into four groups: 1) clinic executives and upper leaders (i.e., Chief Executive Officer, Executive Directors, program administrators, n=20), 2) clinic first-level leaders (i.e. clinical supervisors, n=20), 3) clinicians serving children with emotional and behavioral disorders (n=120), and 4) children with emotional and behavioral disorders (n=720). Inclusion criteria for all groups of participants are intentionally broad to ensure robust and valid analyses.

Inclusion Criteria for Programs

  1. Provide outpatient psychotherapy services to children ages 4 to 18 who have emotional and/ or behavioral disorders and their families
  2. Has at least 3 full time equivalent clinicians on staff
  3. Not currently implementing a digital measurement-based care system clinic wide

Inclusion Criteria for Executives and Upper Leaders

(1) Identified as Chief Executive Officer, Executive Director, or high-level administrator at an enrolled clinic

Inclusion Criteria for first-level leaders (1) Identified as a clinical supervisor or clinical work-group supervisor/ leader at an enrolled clinic

Inclusion Criteria for Clinicians

  1. Employed as staff at participating clinic
  2. Provides services to 3 or more eligible youth clients

Inclusion Criteria for Child/ Caregiver Participants

  1. Child ages 4 to 18 years
  2. Child has been diagnosed with an emotional or behavioral disorder by clinic staff
  3. Clinical staff at the site determined that the youth's treatment needs can be appropriately addressed by the clinic

Exclusion Criteria for Child/ Caregiver Participants

(1) Child does not present with active psychosis, autism or related developmental disorder, or intellectual disability

Sites / Locations

  • University of California, San Diego
  • University of Central Florida
  • Boise State University
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LOCI (Intervention)

Implementation As Usual (Control)

Arm Description

Agencies in the intervention group will receive leadership training and coaching in addition to training and technical assistance to implement the digital measurement based care system.

Agencies in the control group will receive web-based leadership training in addition to training and technical assistance to implement the digital measurement based care system.

Outcomes

Primary Outcome Measures

Fidelity to MBC
Clinician fidelity to the OQ-A, a digital measurement-based care system, will be measured by parent/caregiver reports. Specifically, parents/caregivers will complete the Caregiver Report of Measurement-Based Care measure which assesses the frequency of clinician's use of the measurement-based care system.
Youth Outcomes
Caregivers will be asked about their child's progress throughout treatment in order to assess this relative to their clinician's implementation and fidelity to the MBC system. Caregivers will complete the Short form Assessment for Children (SAC) to measure youth outcomes--specifically, the youth's rate of symptom reduction throughout treatment.

Secondary Outcome Measures

Mechanisms of Fidelity
This study will evaluate mechanisms of fidelity in clinician use of the MBC system. Clinicians will take assessments that measure the leadership style of their supervisors, the organizational climate, and clinicians' intentions to use MBC as these are hypothesized to mediate fidelity. Clinicians will complete the Implementation Leadership Scale (ILS) and the Implementation Climate Scale (ICS) to measure rate of improvement.

Full Information

First Posted
September 9, 2019
Last Updated
July 26, 2023
Sponsor
Boise State University
Collaborators
University of California, San Diego, University of Central Florida, University of Pennsylvania, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04096274
Brief Title
The Implementation and Sustainment of Digital MBC in Youth Mental Health Services
Official Title
Randomized Trial of a Leadership and Organizational Change Strategy to Improve the Implementation and Sustainment of Digital Measurement-based Care in Youth Mental Health Services
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 17, 2022 (Actual)
Study Completion Date
September 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boise State University
Collaborators
University of California, San Diego, University of Central Florida, University of Pennsylvania, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will investigate the effects of an intervention called Leadership and Organizational Change for Implementation (LOCI), relative to implementation as usual (IAU), on clinician fidelity to, and youth service outcomes of, a well-established digital measurement-based care intervention called the Outcomes Questionnaire-Analyst in outpatient community mental health clinics.
Detailed Description
This study will investigate the effects of LOCI on the implementation, fidelity, and sustainment of a digital measurement-based care (MBC) system called the Outcomes Questionnaire Analyst (OQ-A). Over two phases, the investigators will recruit a total of 20 agencies with up to 2 first level leaders per site (max N of 40 total), a minimum of 3 clinicians per site (60 total), and 72 caregivers per site (720 total). Agencies will be randomly assigned to the control condition (implementation as usual of the OQ-A system) or the intervention condition (the LOCI intervention).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leadership, Behavioral Symptoms
Keywords
LOCI, measurement based care, evidence-based practice, behavioral health, youth mental health, leadership, implementation science

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Clinicians and caregivers of youth were naïve to condition; however, blinding of clinic leaders was not possible.
Allocation
Randomized
Enrollment
686 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LOCI (Intervention)
Arm Type
Experimental
Arm Description
Agencies in the intervention group will receive leadership training and coaching in addition to training and technical assistance to implement the digital measurement based care system.
Arm Title
Implementation As Usual (Control)
Arm Type
Placebo Comparator
Arm Description
Agencies in the control group will receive web-based leadership training in addition to training and technical assistance to implement the digital measurement based care system.
Intervention Type
Behavioral
Intervention Name(s)
Leadership for Organization Change and Implementation (LOCI)
Intervention Description
LOCI is a leadership training and coaching program designed to support leaders and foster a climate that implements and sustains use of evidence based practices.
Intervention Type
Behavioral
Intervention Name(s)
Leadership web-based seminars
Intervention Description
A set of 4 leadership training web-based seminars will be provided that cover topics ranging from effective leadership, to giving effective feedback.
Primary Outcome Measure Information:
Title
Fidelity to MBC
Description
Clinician fidelity to the OQ-A, a digital measurement-based care system, will be measured by parent/caregiver reports. Specifically, parents/caregivers will complete the Caregiver Report of Measurement-Based Care measure which assesses the frequency of clinician's use of the measurement-based care system.
Time Frame
0-24 months after baseline
Title
Youth Outcomes
Description
Caregivers will be asked about their child's progress throughout treatment in order to assess this relative to their clinician's implementation and fidelity to the MBC system. Caregivers will complete the Short form Assessment for Children (SAC) to measure youth outcomes--specifically, the youth's rate of symptom reduction throughout treatment.
Time Frame
0-6 months
Secondary Outcome Measure Information:
Title
Mechanisms of Fidelity
Description
This study will evaluate mechanisms of fidelity in clinician use of the MBC system. Clinicians will take assessments that measure the leadership style of their supervisors, the organizational climate, and clinicians' intentions to use MBC as these are hypothesized to mediate fidelity. Clinicians will complete the Implementation Leadership Scale (ILS) and the Implementation Climate Scale (ICS) to measure rate of improvement.
Time Frame
0-24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participants for this project will fall into four groups: 1) clinic executives and upper leaders (i.e., Chief Executive Officer, Executive Directors, program administrators, n=20), 2) clinic first-level leaders (i.e. clinical supervisors, n=20), 3) clinicians serving children with emotional and behavioral disorders (n=120), and 4) children with emotional and behavioral disorders (n=720). Inclusion criteria for all groups of participants are intentionally broad to ensure robust and valid analyses. Inclusion Criteria for Programs Provide outpatient psychotherapy services to children ages 4 to 18 who have emotional and/ or behavioral disorders and their families Has at least 3 full time equivalent clinicians on staff Not currently implementing a digital measurement-based care system clinic wide Inclusion Criteria for Executives and Upper Leaders (1) Identified as Chief Executive Officer, Executive Director, or high-level administrator at an enrolled clinic Inclusion Criteria for first-level leaders (1) Identified as a clinical supervisor or clinical work-group supervisor/ leader at an enrolled clinic Inclusion Criteria for Clinicians Employed as staff at participating clinic Provides services to 3 or more eligible youth clients Inclusion Criteria for Child/ Caregiver Participants Child ages 4 to 18 years Child has been diagnosed with an emotional or behavioral disorder by clinic staff Clinical staff at the site determined that the youth's treatment needs can be appropriately addressed by the clinic Exclusion Criteria for Child/ Caregiver Participants (1) Child does not present with active psychosis, autism or related developmental disorder, or intellectual disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nate Williams, PhD
Organizational Affiliation
Boise State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States
Facility Name
Boise State University
City
Boise
State/Province
Idaho
ZIP/Postal Code
83725
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.implementationleadership.com/
Description
Information about Leadership for Organizational Change for Implementation (LOCI).
URL
http://www.oqmeasures.com/
Description
Information about the digital measurement-based care system, OQ-A.

Learn more about this trial

The Implementation and Sustainment of Digital MBC in Youth Mental Health Services

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