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NCT05637320
Big Feelings: A Study on Children's Emotions in Therapy
Conditions: Anxiety Disorders, Depressive Disorder, Mood Disorders, Conduct Disorder, Oppositional Defiant Disorder, Regulation, Emotion, Child Behavior Disorders, Trauma and Stressor Related Disorders
Sex: All
Ages: 8 Years – 15 Years
Phase: NA
Enrollment: 404
Sponsor: University of Guelph
Summary
The goal of this clinical trial is to learn about how psychotherapy works for children and adolescents aged 8 - 15 with anxiety, depression, trauma, or disruptive behaviour.
The main question it aims to answer is:• Is the biobehavioural regulation of negative emotion a transdiagnostic mechanism of treatment response in psychotherapy for children with anxiety, depression, trauma and/or disruptive behaviour?Children and their parents will be randomly assigned to an evidence-based, transdiagnostic treatment (the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems; MATCH-ADTC) or a waitlist control condition.
Participants in both groups will complete a baseline assessment, weekly measures consisting of brief symptom scales and medication tracking, and quarterly assessments every 3 months.
Following the intervention/waitlist period, our team will conduct post-test assessments.
All assessments, except for the weekly surveys, will consist of symptom scales, clinical interviews, experimental tasks and physiological measures.
Eligibility Criteria
Inclusion Criteria:Child must be between the ages of 8 and 15 years old and have English proficiencyParents must be over the age of 18 and have English proficiencyMust be seeking psychosocial treatment for concerns related to anxiety, depression, or disruptive behavioursExclusion Criteria:Child has low cognitive functioning that would prevent active participation in research tasksChild reports active suicidality that requiring acute care or hospital interventionChild meets criteria for psychosis, schizophrenia spectrum disorders, eating disorders or autism spectrum disordersChild does not assent to participate in the study
Source: ClinicalTrials.gov (NCT05637320). StuddyBuddy aggregates publicly available trial information.