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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mental Health Care Coordination for Transition Aged Youth

NCT03336892

Mental Health

COMPLETED NA

Early Intervention Foster Care: A Prevention Trial

NCT00701194

School Readiness Developmental Delays

COMPLETED NA

A Treatment Engagement Protocol for Psychiatrically Hospitalized Adolescents at Clinical High Risk for Psychosis

NCT04314635

Psychosis Nos/Other

UNKNOWN PHASE1

Early Prevention of Conduct Problems

NCT00051714

Conduct Disorder

COMPLETED PHASE4

Therapeutic Evaluative Conditioning to Reduce Adolescents' Self-injurious Thoughts and Behaviors During and After Psychiatric Inpatient Hospitalization

NCT05796531

Self-Injurious Behavior Suicidal Ideation Suicide Attempts

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

R34#1 Aim 2 COPE2Thrive Intervention

Randomly clustered youth who have completed the screening will be randomized to receive a resilience based digital intervention, COPE2Thrive.

Group Type EXPERIMENTAL

COPE2Thrive

Intervention Type 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.

Control arm

The comparator arm is treatment as usual. For each monthly crossover, 12 students in a cluster are eligible to receive C2T in a stepped wedge study design. Student outcomes prior to receiving C2T will be compared to outcomes after receiving C2T.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type GENETIC

Children at risk who are not randomized to COPE2Thrive at any point of time serve as the control group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Usual care

Children at risk who are not randomized to COPE2Thrive at any point of time serve as the control group.

Intervention Type GENETIC

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes