Trial Outcomes & Findings for Prevention and Early Identification for High Risk Youth in School-based Clinics (NCT NCT04935710)

NCT ID: NCT04935710

Last Updated: 2026-03-18

Results Overview

The K-CAT-S is a computerized adaptive test for assessment of DSM 5 conditions in youth. Adaptive testing allows the assessment to be done in less than 10 minutes with high validity compared against diagnostic interviews. High scores indicate greater psychopathology. For each of six domains, the minimum score is 0, a score between 45-64 is moderate, a score greater than 65 is severe, and the maximum score is 100. For this primary outcome, the Total K-CAT was used, adding scores across all six domains for a range of 0-600. Change in the numeric level of these symptoms will be the primary outcome of the testing of the preliminary effectiveness of the COPE2Thrive intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

The time frame of assessment of the K-CAT-S is: baseline (at initiation of the intervention, which is 1-, 2-, or 3-weeks after initial screen); completion (1-3 weeks after baseline); and follow-up 3 months

Results posted on

2026-03-18

Participant Flow

Recruitment for the COPE2Thrive (C2T) intervention was contingent on prior participation in the initial screening phase of the study. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Of the 128 eligible students, 39 individuals agreed to participate in the intervention.

Participant milestones

Participant milestones
Measure
Cohort 1
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Participants assigned to Cohort 1 received one week of treatment as usual after enrollment and then initiated the COPE2Thrive (C2T) intervention.
Cohort 2
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Participants assigned to Cohort 2 received two weeks of treatment as usual after enrollment and then initiated the COPE2Thrive (C2T) intervention.
Cohort 3
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Participants assigned to Cohort 3 received three weeks of treatment as usual after enrollment and then initiated the COPE2Thrive (C2T) intervention.
Baseline
STARTED
10
15
14
Baseline
COMPLETED
10
15
14
Baseline
NOT COMPLETED
0
0
0
Completion (1-3 weeks from Baseline)
STARTED
10
15
14
Completion (1-3 weeks from Baseline)
COMPLETED
8
11
11
Completion (1-3 weeks from Baseline)
NOT COMPLETED
2
4
3
Follow-up (3 Months Post-Intervention)
STARTED
8
11
11
Follow-up (3 Months Post-Intervention)
COMPLETED
5
4
7
Follow-up (3 Months Post-Intervention)
NOT COMPLETED
3
7
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort 1
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Participants assigned to Cohort 1 received one week of treatment as usual after enrollment and then initiated the COPE2Thrive (C2T) intervention.
Cohort 2
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Participants assigned to Cohort 2 received two weeks of treatment as usual after enrollment and then initiated the COPE2Thrive (C2T) intervention.
Cohort 3
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Participants assigned to Cohort 3 received three weeks of treatment as usual after enrollment and then initiated the COPE2Thrive (C2T) intervention.
Completion (1-3 weeks from Baseline)
Lost to Follow-up
2
4
3
Follow-up (3 Months Post-Intervention)
Lost to Follow-up
3
7
4

Baseline Characteristics

Prevention and Early Identification for High Risk Youth in School-based Clinics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1
n=10 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 1 received 1 week of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 2
n=15 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 2 received 2 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 3
n=14 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 3 received 3 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Total
n=39 Participants
Total of all reporting groups
Sex/Gender, Customized
Gender · Female
10 Participants
n=110 Participants
10 Participants
n=114 Participants
8 Participants
n=224 Participants
28 Participants
n=104 Participants
Sex/Gender, Customized
Gender · Male
0 Participants
n=110 Participants
5 Participants
n=114 Participants
6 Participants
n=224 Participants
11 Participants
n=104 Participants
Race/Ethnicity, Customized
Race/Ethnicity · White
3 Participants
n=110 Participants
5 Participants
n=114 Participants
4 Participants
n=224 Participants
12 Participants
n=104 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
3 Participants
n=110 Participants
2 Participants
n=114 Participants
3 Participants
n=224 Participants
8 Participants
n=104 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latino
2 Participants
n=110 Participants
3 Participants
n=114 Participants
2 Participants
n=224 Participants
7 Participants
n=104 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Asian
2 Participants
n=110 Participants
4 Participants
n=114 Participants
4 Participants
n=224 Participants
10 Participants
n=104 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Native American
0 Participants
n=110 Participants
0 Participants
n=114 Participants
1 Participants
n=224 Participants
1 Participants
n=104 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Other
0 Participants
n=110 Participants
1 Participants
n=114 Participants
0 Participants
n=224 Participants
1 Participants
n=104 Participants
Age, Continuous
15.8 years
STANDARD_DEVIATION 1.0 • n=110 Participants
15.8 years
STANDARD_DEVIATION 1.2 • n=114 Participants
15.5 years
STANDARD_DEVIATION 1.4 • n=224 Participants
15.7 years
STANDARD_DEVIATION 1.2 • n=104 Participants
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
45.08 Score on a scale
STANDARD_DEVIATION 11.4 • n=110 Participants
39.45 Score on a scale
STANDARD_DEVIATION 14.9 • n=114 Participants
36.2 Score on a scale
STANDARD_DEVIATION 14.3 • n=224 Participants
39.75946 Score on a scale
STANDARD_DEVIATION 13.87813 • n=104 Participants
Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S)
.09 Score on a scale
STANDARD_DEVIATION 0.14 • n=110 Participants
.11 Score on a scale
STANDARD_DEVIATION .15 • n=114 Participants
.07 Score on a scale
STANDARD_DEVIATION .14 • n=224 Participants
0.0864358 Score on a scale
STANDARD_DEVIATION 0.1426804 • n=104 Participants

PRIMARY outcome

Timeframe: The time frame of assessment of the K-CAT-S is: baseline (at initiation of the intervention, which is 1-, 2-, or 3-weeks after initial screen); completion (1-3 weeks after baseline); and follow-up 3 months

Population: All 39 participants were randomized to Cohort 1, Cohort 2, or Cohort 3 based on the timing of initiation of the COPE2Thrive intervention in the stepped wedge design and were included in the analysis population according to their randomized assignment. Differences between the numbers of participants assigned to the arms in the Participant Flow and the numbers reported at later time points reflect loss to follow-up rather than exclusion of participants from the analysis population.

The K-CAT-S is a computerized adaptive test for assessment of DSM 5 conditions in youth. Adaptive testing allows the assessment to be done in less than 10 minutes with high validity compared against diagnostic interviews. High scores indicate greater psychopathology. For each of six domains, the minimum score is 0, a score between 45-64 is moderate, a score greater than 65 is severe, and the maximum score is 100. For this primary outcome, the Total K-CAT was used, adding scores across all six domains for a range of 0-600. Change in the numeric level of these symptoms will be the primary outcome of the testing of the preliminary effectiveness of the COPE2Thrive intervention.

Outcome measures

Outcome measures
Measure
Cohort 1
n=10 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 1 received 1 week of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 2
n=15 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 2 received 2 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 3
n=14 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 3 received 3 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
Baseline
45.08 Score on a scale
Standard Deviation 11.35
39.45 Score on a scale
Standard Deviation 14.90
36.24 Score on a scale
Standard Deviation 14.27
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
Completion (1-3 weeks after baselinee)
41.3 Score on a scale
Standard Deviation 10.4
41.8 Score on a scale
Standard Deviation 16.5
34.4 Score on a scale
Standard Deviation 15.1
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
Follow up (3-months post-intervention)
44.9 Score on a scale
Standard Deviation 14.5
39.8 Score on a scale
Standard Deviation 9.2
21.6 Score on a scale
Standard Deviation 13.3

PRIMARY outcome

Timeframe: The time frame of assessment of the WFIRS-S is: baseline (at initiation of the intervention, which is 1-, 2-, or 3-weeks after initial screen); completion (1-3 weeks after baseline); and follow-up 3 months

Population: All 39 participants were randomized to Cohort 1, Cohort 2, or Cohort 3 based on the timing of initiation of the COPE2Thrive intervention in the stepped wedge design and were included in the analysis population according to their randomized assignment. Differences between the numbers of participants assigned to the arms in the Participant Flow and the numbers reported at later time points reflect loss to follow-up rather than exclusion of participants from the analysis population.

The Weiss Functional Impairment Scale Self Report (WFIRS-S) is an assessment of the student's perception of how emotional and behavior problems have impacted functional impairment over the past month, across six domains including family, school, life skills, child's self-concept, social activities, and risky activities. Higher mean item scores indicate greater functional impairment. The minimum mean item score is 0, the maximum mean item score is 3, and the ROC population cut-off is 0.65. A mean change score of 0.25 is the minimal clinical important difference.

Outcome measures

Outcome measures
Measure
Cohort 1
n=10 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 1 received 1 week of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 2
n=15 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 2 received 2 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 3
n=14 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 3 received 3 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S)
Completion (1-3 weeks after baseline)
0.03 Score on a scale
Standard Deviation 0.08
0.06 Score on a scale
Standard Deviation 0.13
0.03 Score on a scale
Standard Deviation 0.06
Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S)
Baseline
0.08 Score on a scale
Standard Deviation 0.14
0.10 Score on a scale
Standard Deviation 0.15
0.06 Score on a scale
Standard Deviation 0.13
Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S)
Follow up (3 months post-intervention)
0.03 Score on a scale
Standard Deviation 0.07
0 Score on a scale
Standard Deviation 0
0.11 Score on a scale
Standard Deviation 0.20

SECONDARY outcome

Timeframe: Single assessment at Baseline

We administered a single assessment of The Kiddie Computerized Adaptive Testing (K-CAT-P) to participants' parents at baseline to obtain collateral parent report of youth symptoms. The scoring metrics of this testing are identical to the Kiddie Computerized Adaptive Testing Student Report (K-CAT-S). The Kiddie Computerized Adaptive Testing Parent Report (K-CAT-P) screener provides a combined numeric score for each module based on validated quantitative comparisons. Higher scores indicate higher levels of symptoms. The minimum score for any module is 0, a numeric score between 45-64 for any module is considered moderate, a numeric score of 65 or above for any module is considered severe, and the maximum score for any module is 100. Scores for each of the six modules are reported.

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 1 received 1 week of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 2
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 2 received 2 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 3
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 3 received 3 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
Anxiety severity
29.74 Score on a scale
Standard Deviation 17.99
Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
Mania severity
11.98 Score on a scale
Standard Deviation 10.06
Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
Oppositional Defiant Disorder severity
27.56 Score on a scale
Standard Deviation 10.98
Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
Attention-deficit/hyperactivity disorder severity
21.57 Score on a scale
Standard Deviation 7.30
Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
Depression severity
22.01 Score on a scale
Standard Deviation 14.98
Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
Conduct disorder severity
8.72 Score on a scale
Standard Deviation 4.35

SECONDARY outcome

Timeframe: Single assessment at baseline

We administered a single assessment of the Weiss Functional Impairment Scale Parent Report (WFIRS-P) to participants' parents at baseline to obtain collateral parent data. The Weiss Functional Impairment Scale Parent Report (WFIRS-P) is an assessment of the parent's perception of the child's functional impairment over the past month, across six domains including family, school learning and behavior, life skills, child's self-concept, social activities, and risky activities. Higher mean item scores indicate greater functional impairment. The minimum mean item score is 0, the maximum mean item score is 3, and the ROC population cut-off is 0.65. A mean change score of 0.25 is the minimal clinically important difference. Scores for each of the six domains are reported.

Outcome measures

Outcome measures
Measure
Cohort 1
n=12 Participants
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 1 received 1 week of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 2
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 2 received 2 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Cohort 3
A three-group stepped wedge design was implemented. 128 students who completed the initial screening for mental health symptoms and functional impairment were eligible to participate in the study and invited to enroll in the C2T program. Cohort 3 received 3 weeks of treatment as usual, then initiated the COPE2Thrive intervention.
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
Family problems
0.44 Score on a scale
Standard Deviation 0.74
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
School bahaviour
0.10 Score on a scale
Standard Deviation 0.18
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
Life skills
0.69 Score on a scale
Standard Deviation 0.71
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
Self-concept
0.83 Score on a scale
Standard Deviation 0.89
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
Social activities
0.21 Score on a scale
Standard Deviation 0.45
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
Risky activities
0.1 Score on a scale
Standard Deviation 0.18

Adverse Events

Cohort 1

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

Cohort 2

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

Cohort 3

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

Margaret Weiss Danielle

Cambridge Health Alliance

Phone: 617-665-1338

Results disclosure agreements

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