What side effects are associated with this type of intervention?

Common treatments for adolescent wellbeing, such as cognitive-behavioral therapy (CBT), emotion regulation skills training, and resilience-promoting programs, generally have minimal side effects. These can include temporary increases in anxiety or emotional discomfort as individuals confront and process difficult emotions. Challenges related to engagement and adherence, such as resistance to participation or difficulty maintaining motivation, may also occur. Overall, these interventions are safe and beneficial for enhancing mental health resilience in adolescents.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of mood and anxiety disorders in adolescents, which indirectly support adolescent wellbeing by addressing mental health issues early. Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline are commonly approved for treating major depressive disorder and anxiety disorders in this age group. Additionally, cognitive-behavioral therapy (CBT) is a widely endorsed non-pharmacological intervention that has been shown to be effective in promoting mental health resilience. These treatments align with the goals of resilience-based prevention programs by providing early assessment and intervention to improve mental health outcomes in adolescents.

What other types of research exist?

Promising, novel alternatives to the Resilience-Based Prevention Program for adolescent wellbeing include: 1) School-based Cognitive-Behavioral Interventions for Trauma in Schools (CBITS), which provide trauma-focused therapy in a cost-effective manner; 2) Parent-Child Interaction Therapy (PCIT) for young children with anxiety disorders, which involves both the child and parent in treatment; 3) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in sleep-related quality of life and psychological well-being; 4) Affirming mental health approaches for transgender and gender-diverse (TGD) youth, which promote exploration of gender identity in a safe setting; and 5) Early Intensive Behavioral Interventions (EIBI) for children with autism spectrum disorder, which improve cognitive, language, and adaptive behavior.

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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

No Placebo-Only Group

Summary

This trial uses an online tool to identify mental health issues early and offers support to help high-risk youth from diverse backgrounds build resilience. It aims to provide activities that help manage stress, especially for those who often face barriers to getting mental health care.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months or time to completion of the cope2t intervention

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)

Secondary study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Resilience-based prevention programs for adolescent wellbeing focus on early assessment and preventive measures to promote mental health resilience. These programs typically employ cognitive-behavioral strategies, psychoeducation, and skills training to enhance coping mechanisms and emotional regulation. By identifying at-risk youth early and equipping them with tools to manage stress and build resilience, these interventions aim to prevent the onset of mental health issues. This proactive approach is essential for adolescent wellbeing as it helps address potential problems before they escalate, fostering a supportive environment that promotes long-term mental health and stability.

Employing a sequential multiple assignment randomized trial (SMART) to evaluate the impact of brief risk and protective factor prevention interventions for American Indian Youth Suicide.