Community Mental Health ServicesNCT04935710
Prevention and Early Identification for High Risk Youth in School-based Clinics
A study testing COPE2Thrive in people with Community Mental Health Services and Adolescent Well Being, run by Cambridge Health Alliance at 5 sites in United States.
Trial summary
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. The investigators assess a health promotion intervention as a way of reducing treatment disparities in REL-minority youth. Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Community Mental Health Services, Adolescent Well Being, Resilience, Psychological
- What is being tested?
- COPE2Thrive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Jan 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school students in CHA's catchment area (Cambridge, Chelsea, Everett, Malden, Revere, Somerville, Winthrop)
- Youth who are fluent in English, Haitian-Creole, Portuguese, or Spanish.
- Youth who have completed WFIRS and K-CAT, and who do not meet the exclusion criteria.
Who cannot join
- 12th-graders will be excluded from the COPE2Thrive program since the participants will not be available for the study's duration.
- Students who are already receiving behavioral health care.
- Students who are considered to be seriously suicidal and in need of urgent care, in which case the participants would be ineligible based on the fact that the participants will be receiving behavioral health care.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
CHA-Teen Health Center at Cambridge Rindge and Latin School
Cambridge, Massachusetts, 02138-4125
CHA Health Equity Research Lab
Cambridge, Massachusetts, 02141-1047
Community
Cambridge, Massachusetts, 02141
CHA Teen Health Center at Everett High School
Everett, Massachusetts, 02149-5128
CHA Teen Connections at Somerville High School
Somerville, Massachusetts, 02143-1740
About this study
Official title: Prevention and Early Identification for High Risk Youth in School-based Clinics (ALACRITY eSToRY R34 #1)
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.
- The investigators assess a health promotion intervention as a way of reducing treatment disparities in REL-minority youth. This population is underrepresented in child psychiatry research. It is often excluded from clinical trials of medication or therapy because of challenges with transportation, literacy, resources, or other issues.
- The study will take place during or following a healthcare crisis and economic recession, making findings relevant to understanding the mechanisms by which hardship translates into youth mental illness.
- The innovative integration of online screening into school-based clinics and community-based settings in REL-minority communities is made possible by the combination of access to a new technology (CAT) in the context of a learning health community serving a REL-minority population.
- Empirical research on the impact of a resilience-based prevention intervention in youth and youth at risk is both innovative and much needed during this period of health, social and economic crisis.
Read the detailed description
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:
- Tier 1: K-CAT Normal \& WFIRS <0.8 - >1.0 (T <1SD).
- Tier 2: K-CAT Mild \& WFIRS 0.8 - >1.0, K-CAT Moderate \& WFIRS 0.8 - 1.0 (T between 1 and 1.5 SD), K-CAT Severe \& WFIRS 0.8 - 1.0 (T between 1 and 1.5 SD)
- Tier 3: K-CAT Moderate \& WFIRS >1.0 (T >1.5 SD), K-CAT Severe \& WFIRS >1.0 (T >1.5 SD) If patients are symptomatic but not functionally impaired, status is determined by function because symptoms without impairment do not necessarily warrant intervention. If the patient is impaired but not symptomatic, the threshold is determined by symptoms because the patient may be impaired from factors other than the diagnosis. These scores are based on the results of the most severe module of either the K-CAT or the WFIRS. .All students will be eligible to participate in C2T, independent of how they are classified by Tier, unless they meet one of the exclusion criteria. Tier 3 will be informed that the participants' responses suggest that the participants are experiencing some symptoms which are causing them difficulty. As long as the participants are not assessed as critical imminent risk, Tier 3 will also be invited to participate in C2T.
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.
- Conditions
- Community Mental Health Services, Adolescent Well Being, Resilience, Psychological, Health Equity, Screening
- Being tested
- COPE2Thrive, Usual care
- Keywords
- Resilience, Adolescent mental health, Digital therapy, Prevention, Health disparities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPE2ThriveBehavioural
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.
Usual careOther
Also called No intervention
The control group receives usual care for youth at risk in the area of study.
| Study group | Role | What they receive |
|---|---|---|
| R34#1 Aim 2 COPE2Thrive Intervention | Experimental | A three-group stepped wedge design was proposed. 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. Receives: Behavioral: COPE2Thrive |
| 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 outcomes (2)
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.
Measured: 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.
Measured: Single assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start3 Jan 2022
- Primary completion28 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Community Mental Health ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Margaret D Weiss, MD PhD, Cambridge Health Alliance
- Investigators
- Benjamin Cook, PhD, Study chair, Health Equity Research Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935710
- Sponsor's protocol ID
- ALACRITY eSToRY R34 #1
- Other IDs
- P50MH126283
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2021
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Early Identification for High Risk Youth in School-based Clinics (ALACRITY eSToRY R34 #1)
- ClinicalTrials.gov ID
- NCT04935710
- Acronym / sponsor ID
- ALACRITY eSToRY R34 #1
- Conditions
- Community Mental Health Services, Adolescent Well Being, Resilience, Psychological, Health Equity, Screening
- Keywords
- Resilience, Adolescent mental health, Digital therapy, Prevention, Health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The investigators assess a health promotion intervention as a way of reducing treatment disparities in REL-minority youth. This population is underrepresented in child psychiatry research. It is often excluded from clinical trials of medication or therapy because of challenges with transportation, literacy, resources, or other issues.
- The study will take place during or following a healthcare crisis and economic recession, making findings relevant to understanding the mechanisms by which hardship translates into youth mental illness.
- The innovative integration of online screening into school-based clinics and community-based settings in REL-minority communities is made possible by the combination of access to a new technology (CAT) in the context of a learning health community serving a REL-minority population.
- Empirical research on the impact of a resilience-based prevention intervention in youth and youth at risk is both innovative and much needed during this period of health, social and economic crisis.
Detailed description
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:
- Tier 1: K-CAT Normal \& WFIRS <0.8 - >1.0 (T <1SD).
- Tier 2: K-CAT Mild \& WFIRS 0.8 - >1.0, K-CAT Moderate \& WFIRS 0.8 - 1.0 (T between 1 and 1.5 SD), K-CAT Severe \& WFIRS 0.8 - 1.0 (T between 1 and 1.5 SD)
- Tier 3: K-CAT Moderate \& WFIRS >1.0 (T >1.5 SD), K-CAT Severe \& WFIRS >1.0 (T >1.5 SD) If patients are symptomatic but not functionally impaired, status is determined by function because symptoms without impairment do not necessarily warrant intervention. If the patient is impaired but not symptomatic, the threshold is determined by symptoms because the patient may be impaired from factors other than the diagnosis. These scores are based on the results of the most severe module of either the K-CAT or the WFIRS. .All students will be eligible to participate in C2T, independent of how they are classified by Tier, unless they meet one of the exclusion criteria. Tier 3 will be informed that the participants' responses suggest that the participants are experiencing some symptoms which are causing them difficulty. As long as the participants are not assessed as critical imminent risk, Tier 3 will also be invited to participate in C2T.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R34#1 Aim 2 COPE2Thrive Intervention | Experimental | Behavioral: COPE2ThriveA three-group stepped wedge design was proposed. 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 | Other: Usual careThe 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. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- High school students in CHA's catchment area (Cambridge, Chelsea, Everett, Malden, Revere, Somerville, Winthrop)
- Youth who are fluent in English, Haitian-Creole, Portuguese, or Spanish.
- Youth who have completed WFIRS and K-CAT, and who do not meet the exclusion criteria.
Key exclusion criteria (3 listed)
- 12th-graders will be excluded from the COPE2Thrive program since the participants will not be available for the study's duration.
- Students who are already receiving behavioral health care.
- Students who are considered to be seriously suicidal and in need of urgent care, in which case the participants would be ineligible based on the fact that the participants will be receiving behavioral health care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPE2ThriveCognitive 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. | Behavioural | R34#1 Aim 2 COPE2Thrive Intervention |
| Usual careAlso: No interventionThe control group receives usual care for youth at risk in the area of study. | Other | Control arm |
Primary outcome
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
Time frame: 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
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.
Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S)
Time frame: 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
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.
2 secondary outcomes
Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
Time frame: Single assessment at Baseline
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
Time frame: Single assessment at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Cook, PhD study chair
Health Equity Research Lab
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPE2Thrive in people with Community Mental Health Services and Adolescent Well Being, run by Cambridge Health Alliance at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.