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

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ClinicalTrials.gov Identifier: NCT04096274
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : May 7, 2021
Sponsor:
Collaborators:
University of California, San Diego
University of Central Florida
University of Pennsylvania
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boise State University

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.

Condition or disease Intervention/treatment Phase
Leadership Behavioral Symptoms Behavioral: Leadership for Organization Change and Implementation (LOCI) Behavioral: Leadership web-based seminars Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LOCI (Intervention)
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.
Behavioral: Leadership for Organization Change and Implementation (LOCI)
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.

Placebo Comparator: Implementation As Usual (Control)
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.
Behavioral: Leadership web-based seminars
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 Measures :
  1. Fidelity to MBC [ Time Frame: 0-24 months after baseline ]
    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.

  2. Youth Outcomes [ Time Frame: 0-6 months ]
    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 :
  1. Mechanisms of Fidelity [ Time Frame: 0-24 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096274


Contacts
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Contact: Nate Williams, PhD 2084263145 natewilliams@boisestate.edu
Contact: Susan Esp, PhD susanesp@boisestate.edu

Locations
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United States, California
University of California, San Diego Not yet recruiting
San Diego, California, United States, 92093
Contact: Greg Aarons         
Contact: Lauren Brookman-Frazee         
United States, Florida
University of Central Florida Not yet recruiting
Orlando, Florida, United States, 32816
Contact: Mark Ehrhart         
United States, Idaho
Boise State University Recruiting
Boise, Idaho, United States, 83725
Contact: Nate Williams, PhD    208-426-3145    natewilliams@boisestate.edu   
Sub-Investigator: Susan Esp         
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Steven Marcus         
Sponsors and Collaborators
Boise State University
University of California, San Diego
University of Central Florida
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Nate Williams, PhD Boise State University
Additional Information:
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Responsible Party: Boise State University
ClinicalTrials.gov Identifier: NCT04096274    
Other Study ID Numbers: 8424
R01MH119127 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boise State University:
LOCI
measurement based care
evidence-based practice
behavioral health
youth mental health
leadership
implementation science
Additional relevant MeSH terms:
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Behavioral Symptoms