Trial Outcomes & Findings for Predict the Best Level of Care Placement for Each Child's Behavioral Health Needs - Effectiveness Study (NCT NCT06834763)
NCT ID: NCT06834763
Last Updated: 2026-08-07
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
403 participants
At baseline (within 2 weeks of study start) and approximately 60-120 days later
2026-08-07
Participant Flow
Data were collected from all clients as part of standard clinical practice.
Participant milestones
| Measure |
In PSP-Recommended Placement, Child Sample
Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up; completed Child version of the behavioral health assessment
|
Not In PSP-Recommended Placement, Child Sample
Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up; completed Child version of the behavioral health assessment
|
In PSP-Recommended Placement, Adolescent Sample
Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up; completed Adolescent version of the behavioral health assessment
|
Not In PSP-Recommended Placement, Adolescent Sample
Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up; completed Adolescent version of the behavioral health assessment
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
129
|
39
|
169
|
|
Overall Study
COMPLETED
|
66
|
129
|
39
|
169
|
|
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 - Effectiveness Study
Baseline characteristics by cohort
| Measure |
In PSP-Recommended Placement, Child Sample
n=66 Participants
Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
Not In PSP-Recommended Placement, Child Sample
n=129 Participants
Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
In PSP-Recommended Placement, Adolescent Sample
n=39 Participants
Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
Not In PSP-Recommended Placement, Adolescent Sample
n=169 Participants
Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.65 years
STANDARD_DEVIATION 2.94 • n=20 Participants
|
9.64 years
STANDARD_DEVIATION 2.21 • n=20 Participants
|
15.48 years
STANDARD_DEVIATION 1.43 • n=40 Participants
|
14.97 years
STANDARD_DEVIATION 2.13 • n=6 Participants
|
12.28 years
STANDARD_DEVIATION 3.67 • n=7 Participants
|
|
Sex/Gender, Customized
Female
|
23 Participants
n=20 Participants
|
50 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
63 Participants
n=6 Participants
|
153 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Male
|
38 Participants
n=20 Participants
|
68 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
90 Participants
n=6 Participants
|
217 Participants
n=7 Participants
|
|
Sex/Gender, Customized
Unknown/Not reported
|
5 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
16 Participants
n=6 Participants
|
33 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=20 Participants
|
29 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
54 Participants
n=6 Participants
|
104 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=20 Participants
|
69 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
86 Participants
n=6 Participants
|
218 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
32 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
14 Participants
n=6 Participants
|
41 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
14 Participants
n=6 Participants
|
43 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=20 Participants
|
115 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
155 Participants
n=6 Participants
|
360 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 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 |
In PSP-Recommended Placement, Child Sample
n=66 Participants
Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
Not In PSP-Recommended Placement, Child Sample
n=129 Participants
Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
In PSP-Recommended Placement, Adolescent Sample
n=39 Participants
Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
Not In PSP-Recommended Placement, Adolescent Sample
n=169 Participants
Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
|---|---|---|---|---|
|
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
|
-0.09 Z-score
Standard Deviation 0.54
|
-0.15 Z-score
Standard Deviation 0.51
|
0.09 Z-score
Standard Deviation 0.49
|
-0.16 Z-score
Standard Deviation 0.63
|
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 3 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 |
In PSP-Recommended Placement, Child Sample
n=65 Participants
Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
Not In PSP-Recommended Placement, Child Sample
n=126 Participants
Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
In PSP-Recommended Placement, Adolescent Sample
n=38 Participants
Clients in placement with PSP results within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
Not In PSP-Recommended Placement, Adolescent Sample
n=166 Participants
Clients not in placement with PSP result within one standard deviation of the highest predicted likelihood of success for that client at follow up
|
|---|---|---|---|---|
|
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
|
-32.32 Score on a scale
Standard Deviation 17.61
|
-32.88 Score on a scale
Standard Deviation 19.09
|
-4.01 Score on a scale
Standard Deviation 24.67
|
-23.72 Score on a scale
Standard Deviation 18.95
|
Adverse Events
In PSP-Recommended Placement, Child Sample
Not In PSP-Recommended Placement, Child Sample
In PSP-Recommended Placement, Adolescent Sample
Not In PSP-Recommended Placement, 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