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

NCT04935710 | Completed Results

• 2 other identifiers: ALACRITY eSToRY R34 #1P50MH126283
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Community Mental Health Services; Adolescent Well Being; Resilience, Psychological; Health Equity; Screening

Keywords

Resilience; Adolescent mental health; Digital therapy; Prevention; Health disparities

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)

  Single assessment at Baseline

• Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)

  Single assessment at baseline

Study Arms (2)

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.

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.

Other: Usual care

Interventions

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.

R34#1 Aim 2 COPE2Thrive Intervention

Usual care OTHER

The control group receives usual care for youth at risk in the area of study.

Also known as: No intervention

Control arm

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.
• th-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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

CHA-Teen Health Center at Cambridge Rindge and Latin School

Cambridge, Massachusetts, 02138-4125, United States

Location

Community

Cambridge, Massachusetts, 02138, United States

Location

CHA Health Equity Research Lab

Cambridge, Massachusetts, 02141-1047, United States

Location

CHA Teen Health Center at Everett High School

Everett, Massachusetts, 02149-5128, United States

Location

CHA Teen Connections at Somerville High School

Somerville, Massachusetts, 02143-1740, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Margaret Weiss Danielle
• Organization: Cambridge Health Alliance

madweiss@cha.harvard.edu

617-665-1338

Study Officials

• Benjamin Cook, PhD

  Health Equity Research Lab

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: January 3, 2022
• Primary Completion: February 28, 2024
• Study Completion: March 31, 2024
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)