Trial Outcomes & Findings for Personalized Assessment of Client Experiences (NCT NCT04369924)
NCT ID: NCT04369924
Last Updated: 2024-07-03
Results Overview
A youth-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1261 participants
Primary outcome timeframe
baseline, 12 weeks
Results posted on
2024-07-03
Participant Flow
All data reflect adolescent characteristics. Caregivers were not participants in the study.
Participant milestones
| Measure |
Unidimensional Measurement-Based Care
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Multidimensional Measurement-Based Care
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
|---|---|---|
|
Overall Study
STARTED
|
637
|
624
|
|
Overall Study
Completed at Least One Measurement-based Care Measure
|
411
|
370
|
|
Overall Study
Consented to Complete Additional Research Measures
|
67
|
54
|
|
Overall Study
COMPLETED
|
335
|
285
|
|
Overall Study
NOT COMPLETED
|
302
|
339
|
Reasons for withdrawal
| Measure |
Unidimensional Measurement-Based Care
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Multidimensional Measurement-Based Care
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
302
|
339
|
Baseline Characteristics
This measure was only administered to participants who consented to completing additional research measures.
Baseline characteristics by cohort
| Measure |
Unidimensional Measurement-Based Care
n=637 Participants
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Multidimensional Measurement-Based Care
n=624 Participants
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Total
n=1261 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.0 years
STANDARD_DEVIATION 2.1 • n=637 Participants
|
13.9 years
STANDARD_DEVIATION 2.0 • n=624 Participants
|
14.0 years
STANDARD_DEVIATION 2.0 • n=1261 Participants
|
|
Sex: Female, Male
Female
|
339 Participants
n=637 Participants
|
339 Participants
n=624 Participants
|
678 Participants
n=1261 Participants
|
|
Sex: Female, Male
Male
|
298 Participants
n=637 Participants
|
285 Participants
n=624 Participants
|
583 Participants
n=1261 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=637 Participants
|
18 Participants
n=624 Participants
|
34 Participants
n=1261 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
521 Participants
n=637 Participants
|
494 Participants
n=624 Participants
|
1015 Participants
n=1261 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
100 Participants
n=637 Participants
|
112 Participants
n=624 Participants
|
212 Participants
n=1261 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=637 Participants
|
0 Participants
n=624 Participants
|
0 Participants
n=1261 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=637 Participants
|
0 Participants
n=624 Participants
|
1 Participants
n=1261 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=637 Participants
|
0 Participants
n=624 Participants
|
0 Participants
n=1261 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=637 Participants
|
62 Participants
n=624 Participants
|
105 Participants
n=1261 Participants
|
|
Race (NIH/OMB)
White
|
466 Participants
n=637 Participants
|
422 Participants
n=624 Participants
|
888 Participants
n=1261 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=637 Participants
|
16 Participants
n=624 Participants
|
32 Participants
n=1261 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
111 Participants
n=637 Participants
|
124 Participants
n=624 Participants
|
235 Participants
n=1261 Participants
|
|
The Ohio Scales Problem Severity Scale Youth Report
|
19.1 scores on a scale
STANDARD_DEVIATION 16.0 • n=42 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
20.6 scores on a scale
STANDARD_DEVIATION 16.2 • n=32 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
19.8 scores on a scale
STANDARD_DEVIATION 16.0 • n=74 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
|
The Ohio Scales Problem Severity Scale Caregiver Report
|
19.9 scores on a scale
STANDARD_DEVIATION 13.9 • n=43 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
19.3 scores on a scale
STANDARD_DEVIATION 14.4 • n=32 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
19.6 scores on a scale
STANDARD_DEVIATION 14.0 • n=75 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
|
The Ohio Scales Problem Functioning Scale Youth Report
|
55.1 scores on a scale
STANDARD_DEVIATION 16.6 • n=41 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
53.9 scores on a scale
STANDARD_DEVIATION 15.4 • n=31 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
54.6 scores on a scale
STANDARD_DEVIATION 16.0 • n=72 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
|
The Ohio Scales Problem Functioning Scale Caregiver Report
|
49.3 scores on a scale
STANDARD_DEVIATION 17.6 • n=42 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
47.7 scores on a scale
STANDARD_DEVIATION 20.1 • n=31 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
48.6 scores on a scale
STANDARD_DEVIATION 18.6 • n=73 Participants • This measure was only administered to participants who consented to completing additional research measures.
|
|
Symptoms & Functioning Severity Scale- Youth Report
|
52.1 scores on a scale
STANDARD_DEVIATION 10.0 • n=342 Participants • Not all randomized participants went on to complete the measurement-based care measures.
|
50.9 scores on a scale
STANDARD_DEVIATION 10.0 • n=299 Participants • Not all randomized participants went on to complete the measurement-based care measures.
|
51.6 scores on a scale
STANDARD_DEVIATION 10.0 • n=641 Participants • Not all randomized participants went on to complete the measurement-based care measures.
|
|
Symptoms & Functioning Severity Scale- Caregiver Report
|
49.6 scores on a scale
STANDARD_DEVIATION 9.2 • n=220 Participants • Not all youth who were randomized to condition had caregivers who participated in treatment. Not all youth who were randomized to condition had caregivers who completed measurement-based care measures.
|
50.0 scores on a scale
STANDARD_DEVIATION 8.9 • n=184 Participants • Not all youth who were randomized to condition had caregivers who participated in treatment. Not all youth who were randomized to condition had caregivers who completed measurement-based care measures.
|
49.8 scores on a scale
STANDARD_DEVIATION 9.1 • n=404 Participants • Not all youth who were randomized to condition had caregivers who participated in treatment. Not all youth who were randomized to condition had caregivers who completed measurement-based care measures.
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.
A youth-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms.
Outcome measures
| Measure |
Unidimensional Measurement-Based Care
n=9 Participants
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Multidimensional Measurement-Based Care
n=2 Participants
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
|---|---|---|
|
Change in The Ohio Scales Problem Severity Scale Youth Report
|
-4.4 score on a scale
Standard Deviation 9.7
|
4.92 score on a scale
Standard Deviation 9.3
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.
A caregiver-report measure of youth symptoms ranging from 0 to 100, with higher scores indicating higher general mental health symptoms.
Outcome measures
| Measure |
Unidimensional Measurement-Based Care
n=11 Participants
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Multidimensional Measurement-Based Care
n=5 Participants
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
|---|---|---|
|
Change in The Ohio Scales Problem Severity Scale Caregiver Report
|
-2.2 score on a scale
Standard Deviation 7.8
|
5.4 score on a scale
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.
A youth-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning.
Outcome measures
| Measure |
Unidimensional Measurement-Based Care
n=8 Participants
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Multidimensional Measurement-Based Care
n=2 Participants
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
|---|---|---|
|
Change in The Ohio Scales Problem Functioning Scale Youth Report
|
5.5 score on a scale
Standard Deviation 15.6
|
-4.5 score on a scale
Standard Deviation 12.0
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: This measure was only administered to participants who consented to completing additional research measures. Many of these were then lost to follow-up.
A caregiver-report measure of youth functioning in a variety of areas of daily living ranging from 0 to 80, with higher scores indicating better functioning.
Outcome measures
| Measure |
Unidimensional Measurement-Based Care
n=10 Participants
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Multidimensional Measurement-Based Care
n=5 Participants
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
|---|---|---|
|
Change in The Ohio Scales Problem Functioning Scale Caregiver Report
|
2.4 score on a scale
Standard Deviation 6.5
|
-13.4 score on a scale
Standard Deviation 25.3
|
PRIMARY outcome
Timeframe: baseline, up to 18 monthsPopulation: We analyzed youth who completed at least two sets of measures.
A youth-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 33 to 86, with higher scores indicating higher symptoms.
Outcome measures
| Measure |
Unidimensional Measurement-Based Care
n=326 Participants
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Multidimensional Measurement-Based Care
n=220 Participants
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
|---|---|---|
|
Change in Symptoms & Functioning Severity Scale- Youth Report
|
-3.7 score on a scale
Standard Deviation 0.6
|
-3.3 score on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: baseline, up to 18 monthsPopulation: We analyzed data from caregivers who completed at least two sets of measures.
A caregiver-report measure of youth mental health symptoms. Scores are reported as a total score, ranging from 30 to 82, with higher scores indicating higher symptoms.
Outcome measures
| Measure |
Unidimensional Measurement-Based Care
n=220 Participants
Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Unidimensional Measurement-Based Care: Youth and caregivers will complete a symptom rating scale every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
Multidimensional Measurement-Based Care
n=184 Participants
Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
Multidimensional Measurement-Based Care: Youth and caregivers will complete battery of questionnaires covering multiple process and outcome domains every session. Clinicians will receive feedback reports summarizing these data, including alerts indicating if the youth is on track for positive treatment outcomes. These feedback reports will be used to support clinical decision-making.
|
|---|---|---|
|
Change in Symptoms & Functioning Severity Scale- Caregiver Report
|
-2.3 score on a scale
Standard Deviation 0.4
|
-2.6 score on a scale
Standard Deviation 0.4
|
Adverse Events
Unidimensional Measurement-Based Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multidimensional Measurement-Based Care
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place