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

Trial Summary

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 data supports the effectiveness of the treatment EASE for early adolescents in community mental health services?

The research on the FIRST protocol, a similar transdiagnostic approach, shows it is feasible, acceptable, and beneficial for treating anxiety, depression, and conduct-related disorders in youths. This suggests that EASE, which may share similar principles, could also be effective in community mental health settings. ^{1 2 3 4 5}

Is the Early Adolescent Skills for Emotions (EASE) treatment generally safe for humans?

Research on psychotherapy, which includes treatments like EASE, shows that adverse events (unintended negative effects) can occur in more than one in ten participants, with serious events happening in more than one in 21 participants. However, the way these events are recorded and reported varies, making it hard to compare results across studies. ^{6 7 8 9 10}

How is the EASE treatment different from other treatments for early adolescent mental health issues?

The EASE treatment is unique because it focuses on developing emotional skills specifically for early adolescents in community mental health settings, which may not be the primary focus of other treatments. It emphasizes skills development and social integration, making it distinct from more traditional approaches that might not target these areas as directly. ^{11 12 13 14 15}

What is the purpose of this trial?

The EASE program is an existing, evidence-based program/intervention (originally developed by the WHO), and this study is limited to evaluating the local implementation of this program. The aims of this pilot study are to: * Assess the acceptability and feasibility of training and supervision of EASE Helpers (community staff members) through an adapted EASE training. * Evaluate possible problems of recruitment, intervention delivery, and participant retention. * Assess the feasibility of EASE being delivered via a partnership between researchers and community members. * Evaluate implementation of EASE via the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework A mixed-methods design with qualitative and quantitative approaches will be used to assess these objectives.

Research Team

Adam Brown, PhD

Principal Investigator

The New School

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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 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]

References

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2. England pubmed.ncbi.nlm.nih.gov

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

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Exploring Behavioural Activation as a treatment for low mood within CAMHS: An IPA study of adolescent experiences. [2021]

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Psychosocial functioning in adolescent psychiatric patients: a prospective study on changes in psychosocial functioning among severely and moderately impaired adolescent out-patients. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

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

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

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

Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]

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

The Psychiatry Morbidity and Mortality Incident Reporting Tool Increases Psychiatrist Participation in Reporting Adverse Events. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

11. England pubmed.ncbi.nlm.nih.gov

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14. Switzerland 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. [2021]

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

Adapting supported employment for emerging adults with serious mental health conditions. [2018]