COPE2Thrive Program for Adolescent Mental Health

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Cambridge Health Alliance

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the COPE2Thrive treatment for adolescent mental health?

The COPE program, which is part of the COPE2Thrive treatment, has been shown to help depressed and anxious teens by teaching them skills to manage their feelings in short, 30-minute sessions. ^{1 2 3 4 5}

What makes the COPE2Thrive treatment unique for adolescent mental health?

The COPE2Thrive treatment is unique because it combines elements of peer-to-peer support and online interventions, making mental health care more accessible and engaging for adolescents. This approach is different from traditional treatments as it leverages technology and peer interactions to improve help-seeking behaviors and coping skills among young people. ^{6 7 8 9 10}

Eligibility Criteria

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

Students who are already receiving behavioral health care

I am in the 12th grade.

Trial Timeline

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

Treatment Details

Interventions

• Cope2Thrive (Behavioural Intervention)
• COPE2Thrive (Behavioural Intervention)
• 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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

CHA Health Equity Research Lab Cambridge, MA

Community Cambridge, MA

CHA-Teen Health Center at Cambridge Rindge and Latin School Cambridge, MA

CHA Teen Health Center at Everett High School Everett, MA

More Trial Locations

Who Is Running the Clinical Trial?

Cambridge Health Alliance Lead Sponsor

National Institute of Mental Health (NIMH) Collaborator

References

1. England 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. [2021] Evidence-based cognitive-behavioral therapy skills building intervention--Creating Opportunities for Personal Empowerment (COPE)--for depressed and anxious teens in brief 30 min outpatient visits.

2. Australia pubmed.ncbi.nlm.nih.gov

Characteristics and treatment outcomes of children and adolescents accessing treatment in Child and Youth Mental Health Services. [2023] To provide insight into the characteristics and treatment outcomes of children and adolescents accessing outpatient Child and Youth Mental Health Services (CYMHS), and to explore whether outcomes differ by age, sex, and ancestry background. This information can guide how to optimize the treatment delivered at these services.

3. England pubmed.ncbi.nlm.nih.gov

Evaluating the CYP-IAPT transformation of child and adolescent mental health services in Cambridgeshire, UK: a qualitative implementation study. [2022] The Children and Young People's Improving Access to Psychological Therapies (CYP-IAPT) programme was introduced to transform Child and Adolescent Mental Health Services (CAMHS) across England. The programme comprised a set of principles that local CAMHS partnerships were expected to operationalise and embed with the aim of increasing access to services and improving the quality of care. This study explored how the implementation of the CYP-IAPT programme was executed and experienced by CAMHS professionals in the county of Cambridgeshire (UK), and the extent to which the CYP-IAPT principles were perceived to be successfully embedded into everyday practice.

4. England pubmed.ncbi.nlm.nih.gov

Teaching kids to cope: a preventive mental health nursing strategy for adolescents. [2019] The theoretical base, implementation, and effectiveness of Teaching Kids to Cope (TKC).

5. United States pubmed.ncbi.nlm.nih.gov

Ziprasidone in adolescents with schizophrenia: results from a placebo-controlled efficacy and long-term open-extension study. [2022] The purpose of this study was to evaluate the short- and long-term efficacy, safety, and tolerability of ziprasidone in adolescents with schizophrenia.

6. Australia 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. [2023] Innovative youth mental health services around the globe vigorously work on increasing highly needed mental health care accessibility but their service users and care effectiveness have rarely been studied. The Dutch youth walk-in centres of @ease opened in 2018, with currently 11 locations at which free anonymous peer-to-peer counselling is offered to young people aged 12-25. The aim of this protocol is to outline the to-be-conducted research at @ease.

7. Australia pubmed.ncbi.nlm.nih.gov

Promoting positive coping skills for rural youth: benefits for at-risk young people. [2009] To explore the effects of a coping skills program long term and to assess the utility of providing booster intervention. Young people at high risk for depression were of particular interest.

8. England pubmed.ncbi.nlm.nih.gov

Editorial Promoting Help-seeking using E-Technology for ADolescents: The ProHEAD consortium. [2020] Mental health problems are highly prevalent in children and adolescents, but professional help-seeking behavior in this age group is extremely low. Therefore, the ProHEAD ("Promoting Help-seeking using E-technology for Adolescents") consortium focuses on three main objectives, i.e.: (1) improving young people's help-seeking behaviors; (2) improving the selective prevention of common disorders in those who are at risk; and (3) strengthening resources to counteract the development of mental illness. Capitalizing on Internet and mobile technology, ProHEAD delivers low threshold and easily accessible interventions to a large sample of young people. Longitudinal school-based assessments of mental health problems will be conducted at baseline and two annual follow-ups in five regions of Germany in a total sample of 15,000 children and adolescents (aged ≥ 12 years). Based on the results of their baseline assessment, participants are invited to register for one out of five sub-projects. The objectives and procedures of these five randomized controlled trials are published in this issue of Trials.

9. England pubmed.ncbi.nlm.nih.gov

Facilitating mental health help-seeking by young adults with a dedicated online program: a feasibility study of Link. [2019] To explore the feasibility of a dedicated online youth mental health help-seeking intervention and to evaluate using a randomised controlled trial (RCT) study design in order to identify any modifications needed before commencement of the full-scale RCT.

10. Croatia pubmed.ncbi.nlm.nih.gov

A retrospective audit of referrals of 16-17 year olds with reference to substance abuse. [2016] Emerge is an innovative Child and Adolescent Mental Health Service that provides support for 16-17 year olds. The team provide a community based multi-disciplinary, open access model, texting young people and travelling to locations convenient to them. There is an enhanced duty system providing a rapid flexible response within working hours.