COPE2Thrive Program for Adolescent Mental Health

No longer recruiting at 4 trial locations

Overseen By Eleanor C Richards, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Cambridge Health Alliance

Disqualifiers: 12th-graders, Behavioral health care, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital program, COPE2Thrive, designed to boost mental health resilience among high school students in diverse communities. The goal is to address mental health challenges during difficult times, such as economic recessions, by providing preventative support. Participants will either receive this digital intervention or continue with their usual treatment, allowing researchers to compare outcomes. High school students from certain Massachusetts communities who speak English, Haitian Creole, Portuguese, or Spanish and have mild mental health symptoms may be eligible to join. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative program.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications. However, students already receiving behavioral health care are excluded from the study, which might imply that those on certain medications could be ineligible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that COPE2Thrive is based on the COPE program, which has been successfully used in various situations. This program teaches skills to change thinking and behavior. Previous studies have found that COPE programs are generally safe and well-tolerated. For example, the COPE program has reduced depression in teens without causing major side effects.

Although this specific trial is just starting, the use of COPE2Thrive in other situations suggests it is likely safe. Prospective participants can feel reassured by the existing evidence of COPE's safety in similar programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COPE2Thrive program for adolescent mental health because it offers a unique, resilience-based digital intervention. Unlike traditional therapies that often rely on face-to-face counseling or medication, COPE2Thrive leverages digital platforms to deliver mental health support, making it more accessible and convenient for teens. This program aims to empower adolescents by building their resilience and coping skills, potentially leading to better long-term mental health outcomes. Additionally, its innovative stepped wedge design allows for a thorough comparison of results before and after the intervention, providing valuable insights into its effectiveness.

What evidence suggests that the COPE2Thrive intervention could be effective for adolescent mental health?

Research has shown that the COPE2Thrive program, which participants in this trial may receive, can help reduce depression and anxiety in teenagers. Teens who participated in COPE programs made healthier lifestyle choices and felt less sad and hopeless. A review of 115 studies involving over 7,700 young people found similar positive results. These findings suggest that COPE2Thrive's focus on building resilience could be a promising way to support mental health in at-risk youth. This program could help fill gaps in mental health care, especially in communities that often struggle to access such support. ^{2 3 4 6 7}

Who Is on the Research Team?

Benjamin Cook, PhD

Principal Investigator

Health Equity Research Lab

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Youth who have completed WFIRS and K-CAT, and who do not meet the exclusion 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

Students who are considered to be seriously suicidal and in need of urgent care

I am in the 12th grade.

Students who are already receiving behavioral health care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Intervention

Participants receive the COPE2Thrive resilience-based digital intervention

23 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cope2Thrive
• COPE2Thrive
• Usual care

Trial Overview

The study tests COPE2Thrive—a preventive intervention against usual care—to improve adolescent wellbeing and resilience in diverse communities during a healthcare crisis.

How Is the Trial Designed?

Group I: R34#1 Aim 2 COPE2Thrive Intervention Experimental Treatment 1 Intervention

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

Group II: Control arm Active Control 1 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.

Cope2Thrive is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Lynparza for:

• Ovarian cancer
• Breast cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Approved in Canada as Lynparza for:

• Ovarian cancer
• Breast cancer
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 437 young people referred to the Emerge mental health service, 24% reported alcohol use, 19% reported cannabis use, and 9% reported cigarette use, indicating a significant prevalence of substance use among this population.

The findings suggest that the actual rates of substance use may be underestimated due to incomplete documentation, highlighting the need for improved data collection and support strategies for marginalized youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective audit of referrals of 16-17 year olds with reference to substance abuse. Salam, FS., Theodosiou, L., Gillibrand, V., et al.[2016]

The ProHEAD initiative aims to enhance help-seeking behaviors among children and adolescents for mental health issues by utilizing internet and mobile technology, making interventions more accessible to a large population.

The study will involve longitudinal assessments of mental health in 15,000 participants aged 12 and older across five regions in Germany, with follow-ups to evaluate the effectiveness of various targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Promoting Help-seeking using E-Technology for ADolescents: The ProHEAD consortium. Kaess, M., Bauer, S.[2020]

The pilot randomized controlled trial involving 51 young adults (ages 18-25) in Australia found that the Link online mental health help-seeking tool was generally acceptable and feasible, meeting 3 out of 4 intervention criteria and 2 out of 5 study design criteria.

Participants reported that the Link tool was useful and may have improved their attitudes towards seeking help, with no harmful effects observed, indicating a positive initial response to the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating mental health help-seeking by young adults with a dedicated online program: a feasibility study of Link. Kauer, SD., Buhagiar, K., Blake, V., et al.[2019]

A study of 3098 children and adolescents receiving treatment at Child and Youth Mental Health Services in Brisbane revealed that anxiety and mood disorders were the most prevalent, with many patients experiencing multiple disorders and psychosocial stressors.

While there was a significant improvement in mental health symptoms during treatment, with effect sizes around 0.9, about 50% of the participants still had clinical-level symptoms at the end, indicating a need for enhanced treatment strategies to further reduce these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and treatment outcomes of children and adolescents accessing treatment in Child and Youth Mental Health Services. Lu, ZQ., de Geus, H., Roest, S., et al.[2023]

The CYP-IAPT programme aimed to improve Child and Adolescent Mental Health Services in England but faced challenges due to unclear definitions and guidance on how to implement its principles effectively, as revealed by an analysis of 275 documents and interviews with CAMHS professionals.

Staff interviews highlighted a lack of coherent understanding and variable investment in the programme, which created barriers to effective collaboration and implementation, ultimately affecting the sustainability of the initiative in Cambridgeshire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the CYP-IAPT transformation of child and adolescent mental health services in Cambridgeshire, UK: a qualitative implementation study. Burn, AM., Vainre, M., Humphrey, A., et al.[2022]

The Teaching Kids to Cope (TKC) program is a 10-week psychoeducational intervention that has shown promising results in reducing depressive symptoms and enhancing coping skills among adolescents.

While initial findings are positive, further research with larger groups is necessary to fully assess the effectiveness of the TKC intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching kids to cope: a preventive mental health nursing strategy for adolescents. Puskar, KR., Lamb, J., Tusaie-Mumford, K.[2019]

The @ease youth walk-in centres in the Netherlands provide free, anonymous peer-to-peer counseling for young people aged 12-25, aiming to improve accessibility to mental health care, with ongoing research to evaluate their effectiveness and impact.

Three studies will assess the outcomes of @ease visits, including immediate and long-term effects on mental health, cost implications of mental illness, and factors influencing help-seeking behavior, providing valuable insights into the mental wellbeing of underserved youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

@ease peer-to-peer youth walk-in centres in The Netherlands: A protocol for evaluating longitudinal outcomes, follow-up results and cost-of-illness. Boonstra, A., van Mastrigt, GAPG., Evers, SMAA., et al.[2023]

A coping skills program significantly reduced reliance on non-productive coping strategies among 159 high school students at risk for depression, but these benefits were not sustained after 12 months without additional support.

Booster interventions, such as the Coping for Success program, effectively improved problem-solving skills and coping strategies at the 12-month follow-up, indicating that ongoing support is beneficial for maintaining positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting positive coping skills for rural youth: benefits for at-risk young people. Eacott, C., Frydenberg, E.[2009]

In a study involving 283 adolescents with schizophrenia, ziprasidone did not show significant efficacy compared to placebo in reducing symptoms after 6 weeks, although a per-protocol analysis indicated some effectiveness.

Ziprasidone was generally well tolerated, with common side effects including somnolence and extrapyramidal disorders, but it did not lead to significant metabolic changes or weight gain, suggesting a neutral safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ziprasidone in adolescents with schizophrenia: results from a placebo-controlled efficacy and long-term open-extension study. Findling, RL., Cavuş, I., Pappadopulos, E., et al.[2022]

The COPE program is an evidence-based cognitive-behavioral therapy designed for depressed and anxious teens, delivered in brief 30-minute outpatient visits, making it suitable for busy clinical settings.

This program allows advanced practice nurses to effectively utilize their skills to provide timely mental health support to adolescents, enhancing their ability to address common mental health issues in various environments like psychiatric and primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COPE for depressed and anxious teens: a brief cognitive-behavioral skills building intervention to increase access to timely, evidence-based treatment. Lusk, P., Melnyk, BM.[2021]

Citations

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cope2thrive.com

cope2thrive.com/

COPE2Thrive

“According to new CDC data, nearly 3 in 5 (57%) U.S. teen girls felt persistently sad or hopeless in 2021—double that of boys, representing a nearly 60% ...

2.

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cope2thrive.com/intervention-studies-supporting-cope-with-abstracts

Intervention Studies Supporting COPE with Abstracts

RESULTS: Adolescents in the COPE program increased their healthy lifestyle choices and reported a decrease in depressive and anxiety symptoms from baseline to ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10878455/

The evidence-based COPE program: Reducing the time ...

The soaring prevalence of depression and anxiety in children, teenagers, and young adults is now a public health epidemic, yet access to timely ...

4.

jpedhc.org

jpedhc.org/article/S0891-5245(18)30599-6/abstract

Outcomes of a Brief Cognitive Skills-Based Intervention ...

Among these 37 adolescents, COPE provided effective PC-based behavioral treatment and a positive experience. Increased availability of COPE ...

5.

cope2thrive.com

cope2thrive.com/news-stories-of-interest

News Stories of Interest - COPE2Thrive

Researchers from the Mayo Clinic reviewed 115 studies with a total of more than 7,700 youth and teenagers; their results were published in the Journal of the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9072253/

Treating Adolescent Anxiety and Depression in Primary Care ...

Fallout from the COVID-19 pandemic increased rates of pediatric mental illness, especially adolescent depression and anxiety.

7.

avmajournals.avma.org

avmajournals.avma.org/downloadpdf/journals/javma/260/7/javma.21.03.0142.pdf

Effects of a cognitive-behavioral skills building program on ...

Therefore, the purpose of this pre-and postcourse survey study was to evaluate the effects of a cognitive-behavioral skills building MINDSTRONG program on the ...