Trial Outcomes & Findings for Working to Implement and Sustain Digital Outcome Measures (NCT NCT04096274)

NCT ID: NCT04096274

Last Updated: 2024-02-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

686 participants

Primary outcome timeframe

0-6 months after youth's baseline/ entry into treatment

Results posted on

2024-02-20

Participant Flow

Data were only collected from caregivers of youth who received services at participating clinics. Caregivers reported on youth's mental health service experiences and outcomes. Consequently, started and completed numbers shown below only reflect caregivers of eligible youth who participated in services (i.e., number of caregivers enrolled). Youths were not enrolled.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure
LOCI (Intervention)
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. Leadership for Organization Change and Implementation (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. Training and Technical Assistance: All leaders and clinicians in participating clinics will receive standardized OQ-A training and technical assistance provided by the OQ-A purveyor organization.
Training and Technical Assistance Only (Control)
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. Training and Technical Assistance Only: 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.
Phase I
STARTED
117 11
117 10
Phase I
COMPLETED
112 10
112 8
Phase I
NOT COMPLETED
5 1
5 2
Phase II
STARTED
269 11
183 8
Phase II
COMPLETED
258 10
172 8
Phase II
NOT COMPLETED
11 1
11 0

Reasons for withdrawal

Reasons for withdrawal
Measure
LOCI (Intervention)
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. Leadership for Organization Change and Implementation (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. Training and Technical Assistance: All leaders and clinicians in participating clinics will receive standardized OQ-A training and technical assistance provided by the OQ-A purveyor organization.
Training and Technical Assistance Only (Control)
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. Training and Technical Assistance Only: 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.
Phase I
Lost to Follow-up
5
5
Phase II
Lost to Follow-up
11
11

Baseline Characteristics

Data not collected from caregivers for this baseline measure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
LOCI (Intervention)
n=386 Participants
The Leadership for Organization Change and Implementation (LOCI) strategy 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.
Training and Technical Assistance Only (Control)
n=300 Participants
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.
Total
n=686 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Age, Categorical
Between 18 and 65 years
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Age, Categorical
>=65 years
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Sex/Gender, Customized
Male
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Sex/Gender, Customized
Female
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Sex/Gender, Customized
Prefer not to disclose
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Race/Ethnicity, Customized
American Indian or Alaskan Native
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Race/Ethnicity, Customized
Asian
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Race/Ethnicity, Customized
Black or African American
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Race/Ethnicity, Customized
Pacific Islander or Hawaiian Native
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Race/Ethnicity, Customized
Prefer to self-describe
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Race/Ethnicity, Customized
Prefer not to disclose
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Race/Ethnicity, Customized
More than one race (Multiracial)
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Race/Ethnicity, Customized
White
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Race/Ethnicity, Customized
Unknown or not reported
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
0 Participants
Data not collected from caregivers for this baseline measure
Phase I: Youth Short-form Assessment for Children (SAC) Total Problem Score
37.1 units on a scale
STANDARD_DEVIATION 13.6 • n=117 Participants • Data for Phase I only
34.1 units on a scale
STANDARD_DEVIATION 12.8 • n=117 Participants • Data for Phase I only
35.6 units on a scale
STANDARD_DEVIATION 13.2 • n=234 Participants • Data for Phase I only
Phase I: Youth received prior mental health treatment
66 Participants
n=117 Participants • Data for Phase I only
58 Participants
n=117 Participants • Data for Phase I only
124 Participants
n=234 Participants • Data for Phase I only
Phase I: Family Income
Less than $25,750
27 Participants
n=117 Participants • Data for Phase I only
20 Participants
n=117 Participants • Data for Phase I only
47 Participants
n=234 Participants • Data for Phase I only
Phase I: Family Income
$25,751 to $35,535
19 Participants
n=117 Participants • Data for Phase I only
18 Participants
n=117 Participants • Data for Phase I only
37 Participants
n=234 Participants • Data for Phase I only
Phase I: Family Income
$35,536 to $51,500
19 Participants
n=117 Participants • Data for Phase I only
20 Participants
n=117 Participants • Data for Phase I only
39 Participants
n=234 Participants • Data for Phase I only
Phase I: Family Income
More than $51,500
50 Participants
n=117 Participants • Data for Phase I only
59 Participants
n=117 Participants • Data for Phase I only
109 Participants
n=234 Participants • Data for Phase I only
Phase I: Family Income
Unknown or not reported
2 Participants
n=117 Participants • Data for Phase I only
0 Participants
n=117 Participants • Data for Phase I only
2 Participants
n=234 Participants • Data for Phase I only
Phase I: Parent Highest Education Level
High school graduate/GED or less
25 Participants
n=117 Participants • Data for Phase I only
23 Participants
n=117 Participants • Data for Phase I only
48 Participants
n=234 Participants • Data for Phase I only
Phase I: Parent Highest Education Level
Associate's degree or some college
48 Participants
n=117 Participants • Data for Phase I only
42 Participants
n=117 Participants • Data for Phase I only
90 Participants
n=234 Participants • Data for Phase I only
Phase I: Parent Highest Education Level
Bachelor's degree
26 Participants
n=117 Participants • Data for Phase I only
28 Participants
n=117 Participants • Data for Phase I only
54 Participants
n=234 Participants • Data for Phase I only
Phase I: Parent Highest Education Level
Graduate degree
18 Participants
n=117 Participants • Data for Phase I only
24 Participants
n=117 Participants • Data for Phase I only
42 Participants
n=234 Participants • Data for Phase I only
Phase I: Parent Highest Education Level
Unknown or not reported
0 Participants
n=117 Participants • Data for Phase I only
0 Participants
n=117 Participants • Data for Phase I only
0 Participants
n=234 Participants • Data for Phase I only
Phase I: Youth age
11.3 years
STANDARD_DEVIATION 3.7 • n=117 Participants • Data for Phase I only
12.1 years
STANDARD_DEVIATION 4.0 • n=117 Participants • Data for Phase I only
11.7 years
STANDARD_DEVIATION 3.8 • n=234 Participants • Data for Phase I only
Phase I: Youth sex
Male
54 Participants
n=117 Participants • Data for Phase I only
54 Participants
n=117 Participants • Data for Phase I only
108 Participants
n=234 Participants • Data for Phase I only
Phase I: Youth sex
Female
62 Participants
n=117 Participants • Data for Phase I only
63 Participants
n=117 Participants • Data for Phase I only
125 Participants
n=234 Participants • Data for Phase I only
Phase I: Youth sex
Prefer not to disclose
1 Participants
n=117 Participants • Data for Phase I only
0 Participants
n=117 Participants • Data for Phase I only
1 Participants
n=234 Participants • Data for Phase I only
Phase I: Youth Race
American Indian or Alaskan Native
1 Participants
n=117 Participants • Data for Phase I only
2 Participants
n=117 Participants • Data for Phase I only
3 Participants
n=234 Participants • Data for Phase I only
Phase I: Youth Race
Asian
1 Participants
n=386 Participants • Data for Phase I only
1 Participants
n=300 Participants • Data for Phase I only
2 Participants
n=686 Participants • Data for Phase I only
Phase I: Youth Race
Black or African American
1 Participants
n=386 Participants • Data for Phase I only
2 Participants
n=300 Participants • Data for Phase I only
3 Participants
n=686 Participants • Data for Phase I only
Phase I: Youth Race
Multiracial
10 Participants
n=386 Participants • Data for Phase I only
6 Participants
n=300 Participants • Data for Phase I only
16 Participants
n=686 Participants • Data for Phase I only
Phase I: Youth Race
Pacific Islander or Hawaiian Native
0 Participants
n=386 Participants • Data for Phase I only
0 Participants
n=300 Participants • Data for Phase I only
0 Participants
n=686 Participants • Data for Phase I only
Phase I: Youth Race
Prefer to self-describe
3 Participants
n=386 Participants • Data for Phase I only
2 Participants
n=300 Participants • Data for Phase I only
5 Participants
n=686 Participants • Data for Phase I only
Phase I: Youth Race
White
98 Participants
n=386 Participants • Data for Phase I only
103 Participants
n=300 Participants • Data for Phase I only
201 Participants
n=686 Participants • Data for Phase I only
Phase I: Youth Race
Prefer not to disclose
3 Participants
n=386 Participants • Data for Phase I only
1 Participants
n=300 Participants • Data for Phase I only
4 Participants
n=686 Participants • Data for Phase I only
Phase I: Youth Hispanic/ Latinx Ethnicity
21 Participants
n=117 Participants • Date for Phase I only
14 Participants
n=117 Participants • Date for Phase I only
35 Participants
n=234 Participants • Date for Phase I only
Phase II: Youth Short-form Assessment for Children (SAC) Total Problem Score
35.1 units on a scale
STANDARD_DEVIATION 13.3 • n=269 Participants • Data for Phase II only
34.7 units on a scale
STANDARD_DEVIATION 13.6 • n=183 Participants • Data for Phase II only
34.9 units on a scale
STANDARD_DEVIATION 13.4 • n=452 Participants • Data for Phase II only
Phase II: Youth received prior mental health treatment
153 Participants
n=269 Participants • Data for Phase II only
110 Participants
n=183 Participants • Data for Phase II only
263 Participants
n=452 Participants • Data for Phase II only
Phase II: Family income
Less than $25,750
57 Participants
n=269 Participants • Data for Phase II only
34 Participants
n=183 Participants • Data for Phase II only
91 Participants
n=452 Participants • Data for Phase II only
Phase II: Family income
$25,751 to $35,535
45 Participants
n=269 Participants • Data for Phase II only
25 Participants
n=183 Participants • Data for Phase II only
70 Participants
n=452 Participants • Data for Phase II only
Phase II: Family income
$35,536 to $51,500
55 Participants
n=269 Participants • Data for Phase II only
29 Participants
n=183 Participants • Data for Phase II only
84 Participants
n=452 Participants • Data for Phase II only
Phase II: Family income
More than $51,500
107 Participants
n=269 Participants • Data for Phase II only
91 Participants
n=183 Participants • Data for Phase II only
198 Participants
n=452 Participants • Data for Phase II only
Phase II: Family income
Unknown
5 Participants
n=269 Participants • Data for Phase II only
4 Participants
n=183 Participants • Data for Phase II only
9 Participants
n=452 Participants • Data for Phase II only
Phase II: Parent Highest Education Level
High school graduate/ GED or less
37 Participants
n=269 Participants • Data for Phase II only
29 Participants
n=183 Participants • Data for Phase II only
66 Participants
n=452 Participants • Data for Phase II only
Phase II: Parent Highest Education Level
Associate's degree or some college
129 Participants
n=269 Participants • Data for Phase II only
76 Participants
n=183 Participants • Data for Phase II only
205 Participants
n=452 Participants • Data for Phase II only
Phase II: Parent Highest Education Level
Bachelor's degree
64 Participants
n=269 Participants • Data for Phase II only
53 Participants
n=183 Participants • Data for Phase II only
117 Participants
n=452 Participants • Data for Phase II only
Phase II: Parent Highest Education Level
Graduate degree
34 Participants
n=269 Participants • Data for Phase II only
25 Participants
n=183 Participants • Data for Phase II only
59 Participants
n=452 Participants • Data for Phase II only
Phase II: Parent Highest Education Level
Unknown
5 Participants
n=269 Participants • Data for Phase II only
0 Participants
n=183 Participants • Data for Phase II only
5 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth age
10.5 years
STANDARD_DEVIATION 3.6 • n=269 Participants • Data for Phase II only
11.6 years
STANDARD_DEVIATION 3.8 • n=183 Participants • Data for Phase II only
10.9 years
STANDARD_DEVIATION 3.7 • n=452 Participants • Data for Phase II only
Phase II: Youth sex
Male
118 Participants
n=269 Participants • Data for Phase II only
67 Participants
n=183 Participants • Data for Phase II only
185 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth sex
Female
149 Participants
n=269 Participants • Data for Phase II only
114 Participants
n=183 Participants • Data for Phase II only
263 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth sex
Prefer not to disclose
2 Participants
n=269 Participants • Data for Phase II only
2 Participants
n=183 Participants • Data for Phase II only
4 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth race
American Indian or Alaskan Native
5 Participants
n=269 Participants • Data for Phase II only
0 Participants
n=183 Participants • Data for Phase II only
5 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth race
Asian
3 Participants
n=269 Participants • Data for Phase II only
2 Participants
n=183 Participants • Data for Phase II only
5 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth race
Black or African American
2 Participants
n=269 Participants • Data for Phase II only
3 Participants
n=183 Participants • Data for Phase II only
5 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth race
Pacific Islander or Hawaiian Native
1 Participants
n=269 Participants • Data for Phase II only
0 Participants
n=183 Participants • Data for Phase II only
1 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth race
Prefer not to disclose
3 Participants
n=269 Participants • Data for Phase II only
0 Participants
n=183 Participants • Data for Phase II only
3 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth race
Prefer to self-describe
12 Participants
n=269 Participants • Data for Phase II only
5 Participants
n=183 Participants • Data for Phase II only
17 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth race
Multiracial
20 Participants
n=269 Participants • Data for Phase II only
13 Participants
n=183 Participants • Data for Phase II only
33 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth race
White
223 Participants
n=269 Participants • Data for Phase II only
160 Participants
n=183 Participants • Data for Phase II only
383 Participants
n=452 Participants • Data for Phase II only
Phase II: Youth Hispanic/ Latinx Ethnicity
40 Participants
n=269 Participants • Data for Phase II only
21 Participants
n=183 Participants • Data for Phase II only
61 Participants
n=452 Participants • Data for Phase II only

PRIMARY outcome

Timeframe: 0-6 months after youth's baseline/ entry into treatment

Population: Youths from the Phase I Cohort were included in this analysis.

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.

Outcome measures

Outcome measures
Measure
LOCI (Intervention)
n=117 Participants
The Leadership for Organization Change and Implementation (LOCI) strategy 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.
Training and Technical Assistance Only (Control)
n=117 Participants
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%)
23.1 percentage fidelity achieved
Standard Error 9.0
3.4 percentage fidelity achieved
Standard Error 2.5

PRIMARY outcome

Timeframe: 0-6 months after youth's baseline/ entry into treatment

Population: Analysis includes youths from 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.

Outcome measures

Outcome measures
Measure
LOCI (Intervention)
n=117 Participants
The Leadership for Organization Change and Implementation (LOCI) strategy 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.
Training and Technical Assistance Only (Control)
n=117 Participants
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.
Change From Baseline to 6-months in Youth Total Problems Score on the Short Form Assessment for Children (SAC) - Phase I Cohort
-8.17 units on a scale
Standard Error 1.19
-4.04 units on a scale
Standard Error 1.15

PRIMARY outcome

Timeframe: 0-6 months after youth's baseline/ entry into treatment

Population: Analyses based on an intent-to-treat approach. Note that one clinic was identified as an extreme outlier and consequently was excluded from analyses.

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.

Outcome measures

Outcome measures
Measure
LOCI (Intervention)
n=269 Participants
The Leadership for Organization Change and Implementation (LOCI) strategy 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.
Training and Technical Assistance Only (Control)
n=146 Participants
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%)
5.65 percentage fidelity achieved
Standard Error 4.79
0.97 percentage fidelity achieved
Standard Error 1.27

PRIMARY outcome

Timeframe: 0-6 months after youth's baseline/ entry into treatment

Population: One clinic was excluded from analyses because it was an extreme outlier.

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.

Outcome measures

Outcome measures
Measure
LOCI (Intervention)
n=269 Participants
The Leadership for Organization Change and Implementation (LOCI) strategy 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.
Training and Technical Assistance Only (Control)
n=146 Participants
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.
Change From Baseline to 6-months in Youth Total Problems Score on the Short-form Assessment for Children (SAC) - Phase II Cohort
-4.82 units on a scale
Standard Error .70
-5.19 units on a scale
Standard Error 1.02

Adverse Events

LOCI (Intervention)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Training and Technical Assistance Only (Control)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nathaniel Williams

Boise State University

Phone: 2084263145

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place