Trial Outcomes & Findings for Predict the Best Level of Care Placement for Each Child's Behavioral Health Needs - Efficacy Study (NCT NCT06815562)
NCT ID: NCT06815562
Last Updated: 2026-07-08
Results Overview
The Child Treatment Outcome Package (TOP-CS) is a 48-item scale for children (ages 3 - 18) that assesses 13 domains. The Adolescent TOP-CS is a 58-item scale for adolescents (ages 11 - 21) that assesses 12 domains. TOP-CS assesses the client's past 2-week experience on domains including Depression, Violence, and Suicidality (scores are risk-adjusted for case mix variables assessed via 37 items on the companion TOP-Case Mix form regarding stressful life events, comorbidity). Participants answer "All" to "None of the Time" for each item on a 6-point Likert scale. A domain z-score of 0 represents the general population mean. Domain z-scores are averaged into a summary score per participant. Higher (more positive) average z-scores indicate greater symptom severity and lower behavioral well-being (a worse outcome). The value reported is the mean difference in this average z-score between baseline and follow-up; a negative mean difference indicates improvement (reduced severity).
COMPLETED
NA
213 participants
At baseline (within 2 weeks of study start) and approximately 60-120 days later
2026-07-08
Participant Flow
Data were collected from all clients as part of standard clinical practice. Only clients with valid data at baseline and follow-up were included in these samples.
Participant milestones
| Measure |
Experimental, Child Sample
The system provides site-specific placement success prediction (PSP) scores \[i.e., client's likelihood of success per placement based on machine learning models\] for each youth randomized to this condition in the efficacy study.
|
Control, Child Sample
No site-specific placement success prediction (PSP) scores were generated.
|
Experimental, Adolescent Sample
The system provides site-specific placement success prediction (PSP) scores \[i.e., client's likelihood of success per placement based on machine learning models\] for each youth randomized to this condition in the efficacy study.
|
Control, Adolescent Sample
No site-specific placement success prediction (PSP) scores were generated.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
27
|
76
|
75
|
|
Overall Study
COMPLETED
|
35
|
27
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Predict the Best Level of Care Placement for Each Child's Behavioral Health Needs - Efficacy Study
Baseline characteristics by cohort
| Measure |
Experimental, Child Sample
n=35 Participants
The system provides site-specific placement success prediction (PSP) scores \[i.e., client's likelihood of success per placement based on machine learning models\] for each youth randomized to this condition in the efficacy study. Client completed Child version of the behavioral health assessment.
|
Control, Child Sample
n=27 Participants
No site-specific placement prediction success (PSP) scores were generated. Client completed Child version of the behavioral health assessment.
|
Experimental, Adolescent Sample
n=76 Participants
The system provides site-specific placement success prediction (PSP) scores \[i.e., client's likelihood of success per placement based on machine learning models\] for each youth randomized to this condition in the efficacy study. Client completed Adolescent version of the behavioral health assessment.
|
Control, Adolescent Sample
n=75 Participants
No site-specific placement prediction success (PSP) scores were generated. Client completed Adolescent version of the behavioral health assessment.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.09 years
STANDARD_DEVIATION 1.72 • n=9 Participants
|
13.33 years
STANDARD_DEVIATION 3.08 • n=27 Participants
|
16.01 years
STANDARD_DEVIATION 1.58 • n=267 Participants
|
16.12 years
STANDARD_DEVIATION 1.40 • n=265 Participants
|
15.4 years
STANDARD_DEVIATION 2.08 • n=568 Participants
|
|
Sex/Gender, Customized
Female
|
17 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
29 Participants
n=267 Participants
|
37 Participants
n=265 Participants
|
91 Participants
n=568 Participants
|
|
Sex/Gender, Customized
Male
|
14 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
37 Participants
n=267 Participants
|
37 Participants
n=265 Participants
|
104 Participants
n=568 Participants
|
|
Sex/Gender, Customized
Unknown/Unreported
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
18 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
8 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
30 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
52 Participants
n=267 Participants
|
53 Participants
n=265 Participants
|
148 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
9 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
7 Participants
n=265 Participants
|
16 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
23 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
67 Participants
n=267 Participants
|
65 Participants
n=265 Participants
|
190 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: At baseline (within 2 weeks of study start) and approximately 60-120 days laterThe Child Treatment Outcome Package (TOP-CS) is a 48-item scale for children (ages 3 - 18) that assesses 13 domains. The Adolescent TOP-CS is a 58-item scale for adolescents (ages 11 - 21) that assesses 12 domains. TOP-CS assesses the client's past 2-week experience on domains including Depression, Violence, and Suicidality (scores are risk-adjusted for case mix variables assessed via 37 items on the companion TOP-Case Mix form regarding stressful life events, comorbidity). Participants answer "All" to "None of the Time" for each item on a 6-point Likert scale. A domain z-score of 0 represents the general population mean. Domain z-scores are averaged into a summary score per participant. Higher (more positive) average z-scores indicate greater symptom severity and lower behavioral well-being (a worse outcome). The value reported is the mean difference in this average z-score between baseline and follow-up; a negative mean difference indicates improvement (reduced severity).
Outcome measures
| Measure |
Experimental, Child Sample
n=35 Participants
The system provides site-specific placement success prediction (PSP) scores \[i.e., client's likelihood of success per placement based on machine learning models\] for each youth randomized to this condition in the efficacy study.
|
Control, Child Sample
n=27 Participants
No site-specific placement prediction success (PSP) scores were generated.
|
Experimental, Adolescent Sample
n=76 Participants
The system provides site-specific placement success prediction (PSP) scores \[i.e., client's likelihood of success per placement based on machine learning models\] for each youth randomized to this condition in the efficacy study.
|
Control, Adolescent Sample
n=75 Participants
No site-specific placement prediction success (PSP) scores were generated.
|
|---|---|---|---|---|
|
Mean Difference in Average Domain Z-scores Across Raters Within Two Weeks on the Clinical Scale of the Treatment Outcome Package (TOP-CS) Between a) Baseline and b) Follow-up.
|
0.45 Z-score
Standard Deviation 2.96
|
0.14 Z-score
Standard Deviation 1.04
|
-0.06 Z-score
Standard Deviation 0.56
|
-0.20 Z-score
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: At baseline (within 2 weeks of study start) and approximately 60-120 days laterPopulation: The overall #s of participants analyzed for the secondary outcome is smaller than the #s of participants in the Overall Study because a TOP Total Score was not available for 5 participants due to missing item-level data.
The Child Treatment Outcome Package (TOP-CS) is a 48-item scale for children (ages 3 - 18) that assesses 13 domains. The Adolescent TOP-CS is a 58-item scale for adolescents (ages 11 - 21) that assesses 12 behavioral health domains. Participants answer "All" to "None of the Time" for each item on a 6-point Likert scale. The TOP-CS Total Score is computed by averaging item responses. The range is 48 to 288 for the Child TOP-CS and 56 to 336 for the Adolescent TOP-CS. Higher Total Scores represent better behavioral well-being (a better outcome). Total Scores are averaged across raters per participant. The value reported is the mean difference between each participant's model-predicted, risk-adjusted Total Score (the outcome expected given their baseline profile) and their actual observed Total Score at follow-up. A positive mean difference indicates that the actual follow-up outcome exceeded the model-predicted outcome (i.e., the participant did better than predicted).
Outcome measures
| Measure |
Experimental, Child Sample
n=34 Participants
The system provides site-specific placement success prediction (PSP) scores \[i.e., client's likelihood of success per placement based on machine learning models\] for each youth randomized to this condition in the efficacy study.
|
Control, Child Sample
n=26 Participants
No site-specific placement prediction success (PSP) scores were generated.
|
Experimental, Adolescent Sample
n=75 Participants
The system provides site-specific placement success prediction (PSP) scores \[i.e., client's likelihood of success per placement based on machine learning models\] for each youth randomized to this condition in the efficacy study.
|
Control, Adolescent Sample
n=73 Participants
No site-specific placement prediction success (PSP) scores were generated.
|
|---|---|---|---|---|
|
Mean Difference Between the Average Risk-adjusted Predicted TOP-CS Total Score Across Raters at Study Baseline and the Actual Average TOP-CS Total Score Across Raters at Follow-up
|
-32.90 Score on a scale
Standard Deviation 23.55
|
-36.80 Score on a scale
Standard Deviation 24.40
|
4.67 Score on a scale
Standard Deviation 15.82
|
2.67 Score on a scale
Standard Deviation 30.35
|
Adverse Events
Experimental, Child Sample
Control, Child Sample
Experimental, Adolescent Sample
Control, Adolescent Sample
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place