Early Adolescent Skills for Emotions for Community Mental Health Services

(EASE Trial)

Overseen By Tina Xu, MA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The New School

Disqualifiers: Severe cognitive impairments, suicide risk

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

Compensation: Varies

Number of Visits: 10

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the local implementation of an existing program called EASE, designed to help young people aged 10 to 15 manage psychological distress through group sessions. The program teaches skills such as identifying emotions, problem-solving, and healthy coping strategies. The trial will assess whether community staff can effectively deliver these sessions in partnership with researchers. It seeks English-speaking adolescents who have a caregiver and are not experiencing severe mental health issues. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance mental health support for young people in their community.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the EASE program is safe for adolescents?

Research has shown that the Early Adolescent Skills for Emotions (EASE) program is a safe and well-accepted method to support young people. The World Health Organization created EASE to help 10 to 15-year-olds manage stress and anxiety. It has been implemented in various countries, such as Lebanon and Syria, with positive results.

In the program, young people and their caregivers attend group sessions to learn skills like recognizing emotions, using slow breathing to relax, and solving problems. EASE focuses on teaching skills rather than using medication, and no major side effects have been reported. The program is designed for non-specialists to run, making it accessible in community settings.

Overall, EASE has a strong safety record, with past studies supporting its effectiveness and ease of use for young people dealing with stress and anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

EASE is unique because it offers a structured group therapy approach specifically designed for young adolescents experiencing psychological distress. Unlike typical one-on-one therapy sessions, EASE involves seven group sessions for adolescents and three for their caregivers, promoting a community and support network often lacking in standard treatments. This program is particularly exciting because it incorporates culturally adaptable strategies that have already shown effectiveness in challenging environments like Lebanon and Syria, making it a scalable solution for low- and middle-income countries. Researchers are eager to explore its potential to empower adolescents with practical skills like emotion identification, slow breathing, and problem-solving, which can be transformative for their mental health journey.

What is the effectiveness track record for the EASE program in treating psychological distress in adolescents?

Research shows that the EASE program, provided to participants in this trial, effectively reduces psychological distress in adolescents. Studies have found that EASE helps 10- to 15-year-olds manage stress and anxiety by teaching emotional regulation. In countries like Lebanon and Syria, EASE successfully reduces internalizing problems, such as stress and anxiety. The program uses group sessions to teach skills like slow breathing and problem-solving. Overall, EASE positively impacts adolescents' mental health. ^{3 4 6 7 8}

Who Is on the Research Team?

Adam Brown, PhD

Principal Investigator

The New School

Are You a Good Fit for This Trial?

This trial is for individuals who can benefit from the EASE program, a mental health intervention developed by WHO. It's focused on assessing how well community staff members can be trained to help with this program and its implementation in local settings.

Inclusion Criteria

English-speaking

Has obtained parental permission from a legally authorized representative (e.g. legal guardian)

I am between 10 and 15 years old.

Exclusion Criteria

I do not have severe cognitive impairments or a high risk of suicide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

EASE Intervention

Adolescents participate in seven group sessions and caregivers in three group sessions, each lasting 90 minutes, focusing on emotional skills and coping strategies.

10 weeks

10 group sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments conducted over an 8-month period.

8 months

What Are the Treatments Tested in This Trial?

Interventions

• EASE

Trial Overview The study tests the EASE program's local implementation effectiveness. It looks at training community staff (EASE Helpers), recruitment challenges, delivery of the intervention, retention of participants, and long-term maintenance using mixed methods.

How Is the Trial Designed?

Group I: EASE Intervention Experimental Treatment 1 Intervention

EASE targets psychological distress in adolescents ages 10 to 15 years old through seven group sessions with adolescents and three group sessions with the adolescents' caregivers. Each session is 90 minutes, and adolescents learn and engage in strategies that progress in complexity throughout the intervention. Through EASE, adolescents learn how to identify their emotions, distress-related physical arousal, slow breathing as a healthy coping strategy, behavioral activation to engage in meaningful activities, and problem-solving skills. RCTs have indicated the scalability and efficacy of EASE in LMICs like Lebanon and Syria. To prepare for pilot implementation, researchers from The New School Center for Global Mental Health collected feedback from community partners on EASE in 2024. Based on community recommendations, EASE was adapted for the current study.

Who Is Running the Clinical Trial?

The New School

Lead Sponsor

Trials

5

Recruited

1,400+

Published Research Related to This Trial

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

The FIRST protocol, a transdiagnostic approach to youth psychotherapy, demonstrated high feasibility and acceptability in community clinics, with 86.6% adherence to the treatment protocol and positive feedback from clients and therapists.

Clinical outcomes showed significant improvements, with effect sizes ranging from 0.41 to 2.66, indicating that the FIRST protocol effectively addresses multiple disorders in youths aged 7-15, justifying further research through a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Test of a Principle-Guided Approach to Transdiagnostic Psychotherapy With Children and Adolescents. Weisz, J., Bearman, SK., Santucci, LC., et al.[2018]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

A systematic review of 85 randomized controlled trials involving 14,420 participants found that adverse events (AEs) from psychotherapy can affect more than 10% of participants, with serious AEs occurring in more than 1 in 21 participants.

The study highlighted that the reporting and recording of AEs were inconsistent across trials, suggesting a need for standardized harm monitoring to better evaluate the risks and benefits of psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

The implementation of the Psychiatry Morbidity and Mortality Incident Reporting Tool (PMIRT) led to psychiatrists filing 65 reports over one year, indicating increased engagement in reporting adverse events (AEs).

Following the introduction of PMIRT, the average number of AEs reported in the hospital's formal event reporting system significantly increased, demonstrating that targeted tools can enhance safety reporting practices among psychiatrists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychiatry Morbidity and Mortality Incident Reporting Tool Increases Psychiatrist Participation in Reporting Adverse Events. Kroll, DS., Shellman, AD., Gitlin, DF.[2019]

The Transition_psy study aims to evaluate changes in mental health care needs and quality of life for 300 emerging adults transitioning from Child and Adolescent Mental Health Services (CAMHS) to Adult Mental Health Services (AMHS) over a 24-month period.

This study is significant as it is the first national cohort study on Transition Psychiatry in French-speaking Belgium, focusing on understanding the relationship between genetic, environmental, and clinical factors in developing mental health issues during this critical transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Protocol: Transition_psy a Multicenter Prospective Longitudinal Cohort Study Assessing Risk and Protective Factors to Develop Psychopathology in Transitional Age Youth in Belgium. Reis, J., Marchini, S., De Leeuw, A., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37748283/

Evaluation of the Early Adolescent Skills for Emotions (EASE ... Both EASE and single session psycho-education home visits resulted in meaningful improvements in reducing psychological distress. We did not identify any ...

2. who.int who.int/publications/i/item/9789240082755

Early Adolescent Skills for Emotions (EASE) EASE is an evidence-based group psychological intervention to help 10–15-year-olds affected by internalizing problems (eg stress and symptoms of anxiety, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06934954

NCT06934954 | Early Adolescent Skills for Emotions The EASE program is an existing, evidence-based program/intervention (originally developed by the WHO), and this study is limited to evaluating the local ...

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-04571-9

Feasibility randomised controlled trial of the Early Adolescent ... Retention in T1 assessments was 89% for EASE and 91% for ETAU adolescents, and retention in T2 assessments was 83% for EASE and 94% for ETAU ...

5. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004046

Effectiveness of a brief group behavioural intervention on ... EASE led to reduced internalising problems in young refugee adolescents and was associated with reduced distress and less inconsistent disciplinary parenting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11214135/

Evaluation of the Early Adolescent Skills for Emotions ... This study evaluates the effectiveness of a new group-based intervention developed by the World Health Organization (Early Adolescent Skills for Emotions; EASE)

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3654-3

Early Adolescent Skills for Emotions (EASE) intervention for ... The primary aim of both RCTs is to assess the effectiveness of EASE in treating child-reported symptoms of psychological distress at 3-month ...

8. mhinnovation.net mhinnovation.net/innovations/early-adolescent-skills-emotions-ease-group-psychological-help-young-adolescents

Early Adolescent Skills for Emotions (EASE) EASE is a group psychological intervention for 10 - 15 year olds and their caregivers, which can be delivered by non-specialist providers to improve the mental ...