Clinical trial NCT04935710: Prevention and Early Identification for High Risk Youth in School-based Clinics
Official title: Prevention and Early Identification for High Risk Youth in School-based Clinics (ALACRITY ESToRY R34 #1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Community Mental Health Services
Adolescent Well Being
Resilience, Psychological
Health Equity
Screening
Keywords: Resilience
Adolescent mental health
Digital therapy
Prevention
Health disparities
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-06-23
Enrollment: 108
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
timeFrame: 3 months or time to completion of the COPE2T intervention
Secondary outcomes:
measure: Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S)
timeFrame: 3 months or time to completion of the COPE2Thrive intervention
measure: Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
timeFrame: 3 months or time to completion of the COPE2Thrive intervention
measure: Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
timeFrame: 3 months or time to completion of the COPE2Thrive intervention
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: CHA-Teen Health Center at Cambridge Rindge and Latin School
state: Massachusetts
city: Cambridge
country: United States
facility: Community
state: Massachusetts
city: Cambridge
country: United States
facility: CHA Health Equity Research Lab
state: Massachusetts
city: Everett
country: United States
facility: CHA Teen Health Center at Everett High School
state: Massachusetts
city: Somerville
country: United States
facility: CHA Teen Connections at Somerville High School
state: Massachusetts
Study officials:
affiliation: Health Equity Research Lab
name: Benjamin Cook, PhD
role: STUDY_CHAIR
References: