Clinical trial NCT04096274: Working to Implement and Sustain Digital Outcome Measures
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
Overall status: COMPLETED
Phase: NA
Conditions: Implementation
Behavioral Symptoms
Keywords: LOCI
measurement-based care
evidence-based practice
behavioral health
youth mental health
leadership
implementation science
Lead sponsor: Boise State University
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: University of Central Florida
name: University of Pennsylvania
name: National Institute of Mental Health (NIMH)
First posted: 2019-09-19
Enrollment: 686
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will investigate the effects of an organizational implementation strategy called Leadership and Organizational Change for Implementation (LOCI), relative to training and technical assistance only, on 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: Using a cluster randomized, controlled, hybrid type III effectiveness-implementation design, this trial will investigate the effects of LOCI on the fidelity and and clinical outcomes of a digital measurement-based care (MBC) system called the Outcomes Questionnaire Analyst (OQ-A). The trial will enroll up to 22 outpatient mental health clinics that serve youth and randomly assign them using covariate constrained randomization to either LOCI or training and technical assistance only. Within each clinic, up to 2 first level leaders will be recruited (max N of 40 total) and a minimum of 3 clinicians will be recruited per site (60 total). Data on youth outpatients who receive services will be collected in two phases. In each phase, a unique cohort of 360 caregivers of youth who participate in services will be sampled from the participating clinics. Caregivers will report on the service outcomes and experiences of eligible youth who receive services. The total caregiver enrollment for two phases will be 720 (360\*2).

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) caregivers of children with emotional and behavioral disorders who receive outpatient mental health services within participating clinics (n=720). Caregivers will be recruited in two distinct cohorts of 360 each.

Inclusion criteria for all groups of participants are intentionally broad in line with the pragmatic nature of the trial.

Inclusion Criteria for Clinics

1. Provide outpatient psychotherapy services to children ages 4 to 18 who have emotional and/ or behavioral disorders and their families
2. Have 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 outpatient mental health services (psychotherapy) to youth clients

Inclusion Criteria for Caregivers of Youth Who Receive Services at Participating Clinics

1. Child is ages 4 to 18 years at intake,
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

Primary outcomes:
measure: Percentage Fidelity to the OQ-A System Experienced by the Youth (0-100%)
timeFrame: 0-6 months after youth's baseline/ entry into treatment
measure: Change From Baseline to 6-months in Youth Total Problems Score on the Short Form Assessment for Children (SAC) - Phase I Cohort
timeFrame: 0-6 months after youth's baseline/ entry into treatment
measure: Change From Baseline to 6-months in Youth Total Problems Score on the Short-form Assessment for Children (SAC) - Phase II Cohort
timeFrame: 0-6 months after youth's baseline/ entry into treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
city: Boise
country: United States
facility: Boise State University
state: Idaho
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Boise State University
name: Nate Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: