An interventional study of Leadership for Organization Change and Implementation (LOCI) and Training and Technical Assistance Only in Implementation and Behavioral Symptoms, sponsored by Boise State University. Completed at 4 sites in United States. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Boise State University · Not applicable, Interventional, and Health services research
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.
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).
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
Inclusion Criteria for Executives and Upper Leaders
Inclusion Criteria for first-level leaders
Inclusion Criteria for Clinicians
Inclusion Criteria for Caregivers of Youth Who Receive Services at Participating Clinics
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.
Behavioral: Leadership for Organization Change and Implementation (LOCI) · Behavioral: 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.
Behavioral: Training and Technical Assistance Only
LOCI is a multicomponent implementation strategy that engages organizational executives and first-level leaders (i.e., those who administratively supervise clinicians) to build an organizational climate to support the implementation of a focal evidence-based practice (EBP) with fidelity. In this study, the focal EBP is the OQ-A system. LOCI includes two overarching components: (1) monthly organizational strategy meetings between executives and LOCI consultants/trainers to develop and embed policies, procedures, and practices that support implementation of a focal EBP, and (2) training and coaching for first-level leaders, to develop their skills in leading implementation. The aim of these components is to develop an organizational implementation climate in which clinicians' perceive that use of the OQ-A with high fidelity is expected, supported, and rewarded.
All leaders and clinicians in participating clinics will receive standardized OQ-A training and technical assistance provided by the OQ-A purveyor organization. This includes an initial, 6-hr, in-person OQ-A training; two, live, virtual, 1-hr booster trainings, offered 3 and 5 months after the initial training; and, year-round technical assistance from the OQ-A purveyor organization. Technical assistance includes virtual training sessions, online library of training videos, and customer care representative for technical support. In addition, to encourage participation in the study, a set of four 1-hr, web-based general leadership seminars will be offered to leaders in the control condition. These will cover topics ranging from effective leadership, to giving effective feedback.
Percentage Fidelity to the OQ-A System Experienced by the Youth (0-100%)
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.
Time frame: 0-6 months after youth's baseline/ entry into treatment
Change From Baseline to 6-months in Youth Total Problems Score on the Short Form Assessment for Children (SAC) - Phase I Cohort
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.
Time frame: 0-6 months after youth's baseline/ entry into treatment
Change From Baseline to 6-months in Youth Total Problems Score on the Short-form Assessment for Children (SAC) - Phase II Cohort
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.
Time frame: 0-6 months after youth's baseline/ entry into treatment
| Milestone | LOCI (Intervention) | Training and Technical Assistance Only (Control) |
|---|---|---|
| Started | 117 | 117 |
| Completed | 112 | 112 |
| Not completed | 5 | 5 |
| Withdrew: Lost to follow-up | 5 | 5 |
| Milestone | LOCI (Intervention) | Training and Technical Assistance Only (Control) |
|---|---|---|
| Started | 269 | 183 |
| Completed | 258 | 172 |
| Not completed | 11 | 11 |
| Withdrew: Lost to follow-up | 11 | 11 |
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.
| percentage fidelity achieved | LOCI (Intervention) | Training and Technical Assistance Only (Control) |
|---|---|---|
| Percentage Fidelity to the OQ-A System Experienced by the Youth (0-100%) | 23.1 ± 9.0 | 3.4 ± 2.5 |
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.
| units on a scale | LOCI (Intervention) | Training and Technical Assistance Only (Control) |
|---|---|---|
| Change From Baseline to 6-months in Youth Total Problems Score on the Short Form Assessment for Children (SAC) - Phase I Cohort | -8.17 ± 1.19 | -4.04 ± 1.15 |
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.
| percentage fidelity achieved | LOCI (Intervention) | Training and Technical Assistance Only (Control) |
|---|---|---|
| Percentage Fidelity to the OQ-A System Experienced by the Youth (0-100%) | 5.65 ± 4.79 | 0.97 ± 1.27 |
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.
| units on a scale | LOCI (Intervention) | Training and Technical Assistance Only (Control) |
|---|---|---|
| Change From Baseline to 6-months in Youth Total Problems Score on the Short-form Assessment for Children (SAC) - Phase II Cohort | -4.82 ± .70 | -5.19 ± 1.02 |
Collected over Adverse event data were not collected for caregivers, who were the ones formally enrolled in the study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LOCI (Intervention) | — | — | — |
| Training and Technical Assistance Only (Control) | — | — | — |
The data presented below reflects characteristics of youth as reported by their enrolled caregivers. With the exception of the family variables noted below, data on caregivers was not reported. Required fields for age, race, and sex refer to caregivers and therefore have values of 0 because this data was not reported. Please also note that the baseline characteristics shown below are reported separately for Phase I and Phase II of the trial because each phase was enrolled as a separate cohort.
| Age, Categorical(Participants) | LOCI (Intervention) | Training and Technical Assistance Only (Control) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | LOCI (Intervention) | Training and Technical Assistance Only (Control) | Total |
|---|---|---|---|
| Male | 0 | 0 | 0 |
| Female | 0 | 0 | 0 |
| Prefer not to disclose | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | LOCI (Intervention) | Training and Technical Assistance Only (Control) | Total |
|---|---|---|---|
| American Indian or Alaskan Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| Pacific Islander or Hawaiian Native | 0 | 0 | 0 |
| Prefer to self-describe | 0 | 0 | 0 |
| Prefer not to disclose | 0 | 0 | 0 |
| More than one race (Multiracial) | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| Unknown or not reported | 0 | 0 | 0 |
| Phase I: Youth Short-form Assessment for Children (SAC) Total Problem Score(units on a scale) | LOCI (Intervention) | Training and Technical Assistance Only (Control) | Total |
|---|---|---|---|
| Mean | 37.1 ± 13.6 | 34.1 ± 12.8 | 35.6 ± 13.2 |
| Phase I: Youth received prior mental health treatment(Participants) | LOCI (Intervention) | Training and Technical Assistance Only (Control) | Total |
|---|---|---|---|
| Count of participants | 66 | 58 | 124 |
| Phase I: Family Income(Participants) | LOCI (Intervention) | Training and Technical Assistance Only (Control) | Total |
|---|---|---|---|
| Less than $25,750 | 27 | 20 | 47 |
| $25,751 to $35,535 | 19 | 18 | 37 |
| $35,536 to $51,500 | 19 | 20 | 39 |
| More than $51,500 | 50 | 59 | 109 |
| Unknown or not reported | 2 | 0 | 2 |
| Phase I: Parent Highest Education Level(Participants) | LOCI (Intervention) | Training and Technical Assistance Only (Control) | Total |
|---|---|---|---|
| High school graduate/GED or less | 25 | 23 | 48 |
| Associate's degree or some college | 48 | 42 | 90 |
| Bachelor's degree | 26 | 28 | 54 |
| Graduate degree | 18 | 24 | 42 |
| Unknown or not reported | 0 | 0 | 0 |
| Phase I: Youth age(years) | LOCI (Intervention) | Training and Technical Assistance Only (Control) | Total |
|---|---|---|---|
| Mean | 11.3 ± 3.7 | 12.1 ± 4.0 | 11.7 ± 3.8 |
11 further baseline measures are reported on the registry.
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