Clinical trial

Prevention and Early Identification for High Risk Youth in School-based Clinics (ALACRITY eSToRY R34 #1)

Name
ALACRITY eSToRY R34 #1
Description
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.
Trial arms
Trial start
2022-01-03
Estimated PCD
2024-09-30
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
COPE2Thrive
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.
Arms:
R34#1 Aim 2 COPE2Thrive Intervention
Usual care
Children at risk who are not randomized to COPE2Thrive at any point of time serve as the control group.
Arms:
Control arm
Other names:
No intervention
Size
108
Primary endpoint
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
3 months or time to completion of the COPE2T intervention
Eligibility criteria
Inclusion Criteria for COPE2Thrive: * 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. Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 108, 'type': 'ESTIMATED'}}
Updated at
2024-05-14

1 organization

1 product

6 indications

Product
Usual care
Indication
Resilience
Indication
Mental health
Indication
Health Equity
Indication
screening