Working to Implement and Sustain Digital Outcome Measures

Not Applicable

Completed

Conditions: Behavioral Symptoms
Implementation

Interventions: Behavioral: Leadership for Organization Change and Implementation (LOCI)
Behavioral: Training and Technical Assistance Only

Registration Number: NCT04096274

Lead Sponsor: Boise State University

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 686

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LOCI (Intervention)	Leadership for Organization Change and Implementation (LOCI)	In clinics assigned to the LOCI condition, executives and first-level leaders will receive leadership training and coaching to support implementation of the OQ-A system. In addition, leaders and clinicians in this condition will receive training and technical assistance to implement the OQ-A measurement-based care system.
LOCI (Intervention)	Training and Technical Assistance Only	In clinics assigned to the LOCI condition, executives and first-level leaders will receive leadership training and coaching to support implementation of the OQ-A system. In addition, leaders and clinicians in this condition will receive training and technical assistance to implement the OQ-A measurement-based care system.
Training and Technical Assistance only (Control)	Training and Technical Assistance Only	In clinics assigned to the control group, leaders and clinicians will receive training and technical assistance to implement the OQ-A measurement-based care system. In addition, to support enrollment in this condition, leaders in this condition will be offered access to general web-based leadership seminars.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to 6-months in Youth Total Problems Score on the Short Form Assessment for Children (SAC) - Phase I Cohort	0-6 months after youth's baseline/ entry into treatment	The SAC Total Problem Score is a 48-item measure of youth internalizing (e.g., anxious, depressed) and externalizing (e.g., aggressive, noncompliant, overactive) behaviors (range=0-96) completed by caregivers of youth. Total Problem Score was assessed at baseline (youth's entry into treatment) and monthly for 6 months, change from baseline to month 6 is reported.
Percentage Fidelity to the OQ-A System Experienced by the Youth (0-100%)	0-6 months after youth's baseline/ entry into treatment	Fidelity to the OQ-A will be measured by using electronic meta-data from the OQ-A system combined with caregiver reported information on the number of sessions the youth attended. For each youth, a fidelity index will be generated that represents the product of two quantities: (a) the youth's completion rate (i.e., number of measures administered relative to the number of sessions attended within the 6-month observation period), and (b) the youth's viewing rate (i.e., the number of feedback reports viewed by the clinician relative to the number of measures administered). Note that this product is equivalent to the ratio of viewed feedback reports to total sessions; it represents an events/trials proportion. MBC fidelity index scores summarize the level of MBC fidelity experienced by each youth (range=0-1). Higher scores indicate the youth experienced greater fidelity to MBC.
Change From Baseline to 6-months in Youth Total Problems Score on the Short-form Assessment for Children (SAC) - Phase II Cohort	0-6 months after youth's baseline/ entry into treatment	The SAC Total Problem Score is a 48-item measure of youth internalizing (e.g., anxious, depressed) and externalizing (e.g., aggressive, noncompliant, overactive) behaviors (range=0-96) completed by caregivers of youth. Total Problem Score was assessed at baseline (youth's entry into treatment) and monthly for 6 months, change from baseline to month 6 is reported.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): University of Central Florida
🇺🇸
Orlando, Florida, United States
University of California, San Diego
🇺🇸
San Diego, California, United States
Boise State University
🇺🇸
Boise, Idaho, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States