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COPE2Thrive Program for Adolescent Mental Health

Phase 1
Recruiting
Led By Miriam Tepper, MD
Research Sponsored by Cambridge Health Alliance
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months or time to completion of the cope2t intervention
Awards & highlights

Study Summary

This trial will test a novel intervention to reduce treatment disparities for minority youth in the U.S. by providing early screening and assessment for mental illness.

Who is the study for?
This trial is for high school students in certain areas who speak English, Haitian Creole, Portuguese, or Spanish and show moderate symptoms of mental health issues. It excludes seniors, those already in therapy, or urgently suicidal individuals.Check my eligibility
What is being tested?
The study tests COPE2Thrive—a preventive intervention against usual care—to improve adolescent wellbeing and resilience in diverse communities during a healthcare crisis.See study design
What are the potential side effects?
Since the interventions are non-medical (COPE2Thrive program and usual care), typical drug side effects aren't expected. However, there may be emotional discomfort from discussing personal issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months or time to completion of the cope2t intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months or time to completion of the cope2t intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
Secondary outcome measures
Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: R34#1 Aim 2 COPE2Thrive InterventionExperimental Treatment1 Intervention
Randomly clustered youth who have completed the screening will be randomized to receive a resilience based digital intervention, COPE2Thrive.
Group II: Control armActive Control1 Intervention
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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cambridge Health AllianceLead Sponsor
57 Previous Clinical Trials
20,444 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,167 Total Patients Enrolled
Miriam Tepper, MDPrincipal InvestigatorCambridge Health Alliance

Media Library

Cope2Thrive Clinical Trial Eligibility Overview. Trial Name: NCT04935710 — Phase 1
Adolescent Wellbeing Research Study Groups: R34#1 Aim 2 COPE2Thrive Intervention, Control arm
Adolescent Wellbeing Clinical Trial 2023: Cope2Thrive Highlights & Side Effects. Trial Name: NCT04935710 — Phase 1
Cope2Thrive 2023 Treatment Timeline for Medical Study. Trial Name: NCT04935710 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration sanctioned Cope2Thrive?

"As this is a Phase 1 clinical trial, there is scant data regarding the safety of Cope2Thrive; as such, our team assigned it a score of 1."

Answered by AI

Do I meet the prerequisites to join this research initiative?

"This medical trial seeks 108 adolescents aged 12 to 21, with health equity that are fluent in English, Haitian-Creole, Portuguese or Spanish. Additionally, they must demonstrate a K-CAT-S score of moderate on at least one diagnosis and experience at least mild functional impairment; more severe symptoms or impairments disqualify them from the study. Lastly, participants must attend a high school where CHA School Teen Health Center is present."

Answered by AI

Could you elucidate the key objectives of this research endeavor?

"Over the course of 12 months, this project aims to measure Kiddie Computerized Adaptive Testing Self Report (K-CAT-S). Secondary objectives examine Youth-reported Function (Weiss Functional Impairment Scale - WFIRS), Parent-reported Function (WFIRS) and Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S). Each component gauges an individual's functional impairment over a one month period across family, school, life skills, self concept, social activities & risky behaviour. A mean item score between 0 and 3 is assigned with a ROC population cut off point at 0.65"

Answered by AI

Is enrollment open at this point in time for the trial?

"Clinicaltrials.gov reports that this investigation, initially posted on March 1st 2022, is actively recruiting patients shortly after its latest update dated May 9th 2021."

Answered by AI

How many participants is the research team monitoring in this experiment?

"Affirmative, based on the information hosted by clinicaltrials.gov, this medical study is open for enrollment. Originally posted on March 1st 2022 and last modified 9th May 2022, it's searching for 108 volunteers from 4 different sites."

Answered by AI

Does the trial accept individuals over 60 years of age?

"Based on the trial's criteria, participants need to be between 12 and 21 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prevention and Early Identification for High Risk Youth in School-based Clinics
Margaret D Weiss, MD PhD 2022. "Prevention and Early Identification for High Risk Youth in School-based Clinics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04935710.
~33 spots leftby Apr 2025
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