Ignite Creation Date:
2024-05-06 @ 4:17 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04935710
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2021-06-15
Brief Title:
Prevention and Early Identification for High Risk Youth in School-based Clinics
Sponsor:
Cambridge Health Alliance
Organization:
Cambridge Health Alliance
Study Overview
Official Title:
Prevention and Early Identification for High Risk Youth in School-based Clinics ALACRITY ESToRY R34 1
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed research project provides a novel approach to screening early assessment and preventive interventions for high-risk youth in racialethniclinguistically 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
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 CHAs 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 08 - 10 T 1SD
Tier 2 K-CAT Mild WFIRS 08 - 10 K-CAT Moderate WFIRS 08 - 10 T between 1 and 15 SD K-CAT Severe WFIRS 08 - 10 T between 1 and 15 SD
Tier 3 K-CAT Moderate WFIRS 10 T 15 SD K-CAT Severe WFIRS 10 T 15 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
Tier 1 K-CAT Normal WFIRS 08 - 10 T 1SD
Tier 2 K-CAT Mild WFIRS 08 - 10 K-CAT Moderate WFIRS 08 - 10 T between 1 and 15 SD K-CAT Severe WFIRS 08 - 10 T between 1 and 15 SD
Tier 3 K-CAT Moderate WFIRS 10 T 15 SD K-CAT Severe WFIRS 10 T 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50MH126283 | NIH | None | httpsreporternihgovquickSearchP50MH126283 |