Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50MH126283 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
The proposed research project provides a novel approach to screening, early assessment, and preventive interventions for high-risk youth in racial/ethnic/linguistically (REL)-diverse communities.
Four hundred high school students will be screened for psychiatric symptoms and functional impairment using the Kiddie Computerized Adaptive Testing (K-CAT) and the Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S) in CHA's catchment area (Cambridge, Chelsea, Everett, Malden, Revere, Somerville, Winthrop. Students will be classified into three tiers: normal, at risk, and clinical . The cut off scores that differentiate the tiers are drawn from the ROC values generated by the psychometrics of the measures themselves as follows:
A stepped wedge design with 3 clusters of 36 students each will be used to group students into clusters based on rolling recruitment into COPE2Thrive. The stepped wedge design assigns a random cluster to be switched from the control group to the C2T intervention group at either one, two, or three-week intervals starting at week 1 and ending at week 23 of the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R34#1 Aim 2 COPE2Thrive Intervention | Experimental | A three-group stepped wedge design was originally proposed with 108 youth. During initial screening, we identified 128 individuals met inclusion criteria but only 39 individuals agreed to participate in the study. We randomized these 39 individuals into three cohorts for the stepped wedge design: cohort 1 (n=10), cohort 2 (n=15), and cohort 3 (n=14). Cohort 1 received 1 week of treatment as usual, then initiated the COPE2Thrive intervention. Cohort 2 received 2 weeks of treatment as usual, then initiated the COPE2Thrive intervention. Cohort 3 received 3 weeks of treatment as usual then initiated the COPE2Thrive intervention. |
|
| Control arm | Active Comparator | The control arm includes the same 39 youth randomized to Cohort 1, 2, or 3 during the time period before they were switched into the COPE2THRIVE intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPE2Thrive | Behavioral | Cognitive Behavioral Therapy-based program to help teens deal with anxiety, stress and depression by showing them how to develop skills needed to stop negative thoughts and start thinking and behaving in more positive ways. |
| Measure | Description | Time Frame |
|---|---|---|
| Kiddie Computerized Adaptive Testing Self Report (K-CAT-S) | 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. | 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 |
| Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S) | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P) | 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. |
Not provided
Inclusion Criteria for COPE2Thrive:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Cook, PhD | Health Equity Research Lab | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA-Teen Health Center at Cambridge Rindge and Latin School | Cambridge | Massachusetts | 02138-4125 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual care | Other | The control group receives usual care for youth at risk in the area of study. |
|
|
| Single assessment at Baseline |
| Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) | 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. | Single assessment at baseline |
| Community |
| Cambridge |
| Massachusetts |
| 02138 |
| United States |
| CHA Health Equity Research Lab | Cambridge | Massachusetts | 02141-1047 | United States |
| CHA Teen Health Center at Everett High School | Everett | Massachusetts | 02149-5128 | United States |
| CHA Teen Connections at Somerville High School | Somerville | Massachusetts | 02143-1740 | United States |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Completion (1-3 weeks from Baseline) |
|
|
| Follow-up (3 Months Post-Intervention) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Cohort 1 received 1 week of treatment as usual, then initiated the COPE2Thrive intervention. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sex/Gender, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Kiddie Computerized Adaptive Testing Self Report (K-CAT-S) | The Kiddie Computerized Adaptive Testing Self Report (K-CAT-S) was administered to participants at baseline. It is a computerized adaptive test for assessment of DSM 5 conditions in youth. 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. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S) | The Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S) was administered to participants at baseline. It is 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. | Mean | Standard Deviation | Score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Kiddie Computerized Adaptive Testing Self Report (K-CAT-S) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 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 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P) | 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. | Posted | Mean | Standard Deviation | Score on a scale | Single assessment at Baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) | 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. | Posted | Mean | Standard Deviation | Score on a scale | Single assessment at baseline |
|
|
The time frame for measurement was Baseline (1-, 2- or 3-weeks after initial screen), Completion (1-3 weeks after baseline), and Follow-up (3 months after completion).
An adverse event included all anticipated or unanticipated emotional or behavioral changes due to any cause with the number and frequency of such events by arm or comparison group. Our focus was on all cause mortality, and serious adverse events, which in the context of this study would include any serious deterioration in mental health, suicidal ideation or hospitalization.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 39 | 0 | 39 | 0 | 39 |
| EG001 | 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. | 0 | 39 | 0 | 39 | 0 | 39 |
| EG002 | 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. | 0 | 39 | 0 | 39 | 0 | 39 |
Not provided
Not provided
High rates of refusal to participate limited statistical power. Delays in initiating the intervention for some participants compromised the stepped-wedge timing. Variable follow-up intervals increased heterogeneity in timing of outcome assessment. Missing data required multiple imputation.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Weiss Danielle | Cambridge Health Alliance | 617-665-1338 | madweiss@cha.harvard.edu |
| Sep 29, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: COMPONENT 2 ASSENT FORM | Jul 25, 2023 | Jan 19, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: INTERVIEW INFORMED CONSENT (PARENT/GUARDIAN) | Aug 10, 2022 | Oct 27, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: INFORMED CONSENT (>18 Youth) | Jul 25, 2023 | Oct 27, 2025 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: COMPONENT 2 INFORMED CONSENT (>18 PARENT/GUARDIAN) | Jul 25, 2023 | Oct 27, 2025 | ICF_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: COMPONENT 2 INFORMED CONSENT (>18 YOUTH) | Jul 25, 2023 | Oct 27, 2025 | ICF_005.pdf |
| ICF | No | No | Yes | Informed Consent Form: INFORMED CONSENT (PARENTS/CAREGIVERS) | Jul 25, 2023 | Oct 27, 2025 | ICF_006.pdf |
| ICF | No | No | Yes | Informed Consent Form: COMPONENT 1 ASSENT FORM | Jul 25, 2023 | Jan 19, 2026 | ICF_007.pdf |
| Male |
|
| Black or African American |
|
| Hispanic/Latino |
|
| Asian |
|
| Native American |
|
| Other |
|
| Completion (1-3 weeks after baselinee) |
|
|
| Follow up (3-months post-intervention) |
|
|
The superiority hypothesis was tested using a generalized estimating equation (GEE) population-averaged model with a Gaussian family, identity link, and exchangeable correlation structure. Multiple imputation (m=10) was used to handle missing data. Superiority was concluded if the estimated time effect was significantly different from zero at the alpha = 0.05 level using robust standard errors. |
|
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
|