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

Sponsor
Boise State University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04096274
Collaborator
University of California, San Diego (Other), University of Central Florida (Other), University of Pennsylvania (Other), National Institute of Mental Health (NIMH) (NIH)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Leadership for Organization Change and Implementation (LOCI)
  • Behavioral: Leadership web-based seminars
N/A

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).

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2019
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Fidelity to MBC [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Diego San Diego California United States 92093
2 University of Central Florida Orlando Florida United States 32816
3 Boise State University Boise Idaho United States 83725
4 University of Pennsylvania Philadelphia Pennsylvania United States 19104

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

  • Principal Investigator: Nate Williams, PhD, Boise State University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boise State University
ClinicalTrials.gov Identifier:
NCT04096274
Other Study ID Numbers:
  • 8424
  • R01MH119127
First Posted:
Sep 19, 2019
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boise State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022