Big Feelings: A Study on Children's Emotions in Therapy
NCT ID: NCT05637320
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
202 participants
INTERVENTIONAL
2022-10-01
2027-12-31
Brief Summary
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• 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.
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Detailed Description
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The primary aim of this study is to test biobehavioural regulation of negative emotion as a transdiagnostic mechanism of treatment response in psychotherapy for children with anxiety, depression, trauma, and/or disruptive behavior. Treatment response will be evaluated as pre-to-post change in symptoms and the rate of symptom change. Biobehavioural regulation of emotion will be measured using a multimodal approach comprising validated parent and child-report questionnaires, performance on behavioral and cognitive regulation tasks, and physiological reactivity. Our second aim is to apply association rule mining, a machine learning technique, to uncover patterns governing variations in regulation components throughout the course of treatment. Patterns will be expressed in the form of data-driven and rule-based algorithms reflecting the relation between emotion regulation and treatment response.
Clinicians will be trained on administering the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems (MATCH-ADTC) treatment.
Children aged 8 - 15 seeking psychotherapy for anxiety, depression, trauma, or disruptive behaviour will be recruited from two outpatient mental health clinics. Approximately 202 dyads of a child and parent will be recruited for this study. Participants will be randomly assigned to the intervention arm or the waitlist control arm. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention Arm
Treatment will be administered to participants in this arm.
Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems
The intervention arm will consist of a transdiagnostic psychotherapy program: The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC). MATCH draws from various domains of evidence-based treatment and consists of 33 treatment modules. There are several core module sequences for problem areas such as depression, anxiety, trauma, and disruptive behavior, and a clinician can utilize these sequences based on the primary concern of the presenting child. If an individual reports additional stressors or comorbid conditions, the clinician can modify the sequence of the modules to address these comorbidities. MATCH treatment is flexible and is tailored for each individual client.
Control Arm
No treatment will be administered to participants in this arm until post-test assessment has been completed.
No interventions assigned to this group
Interventions
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Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems
The intervention arm will consist of a transdiagnostic psychotherapy program: The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC). MATCH draws from various domains of evidence-based treatment and consists of 33 treatment modules. There are several core module sequences for problem areas such as depression, anxiety, trauma, and disruptive behavior, and a clinician can utilize these sequences based on the primary concern of the presenting child. If an individual reports additional stressors or comorbid conditions, the clinician can modify the sequence of the modules to address these comorbidities. MATCH treatment is flexible and is tailored for each individual client.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Parents must be over the age of 18 and have English proficiency
* Must be seeking psychosocial treatment for concerns related to anxiety, depression, or disruptive behaviours
Exclusion Criteria
* Child reports active suicidality that requiring acute care or hospital intervention
* Child meets criteria for psychosis, schizophrenia spectrum disorders, eating disorders or autism spectrum disorders
* Child does not assent to participate in the study
8 Years
15 Years
ALL
No
Sponsors
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Centre for Addiction and Mental Health
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University of Guelph
OTHER
Responsible Party
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Kristel Thomassin
Associate Professor
Principal Investigators
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Kristel Thomassin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Guelph
Locations
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Maplewoods Centre for Family Therapy and Child Psychology
Guelph, Ontario, Canada
The Centre for Addition and Mental Health
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Kristel Thomassin, PhD
Role: primary
Brendan Andrade, PhD
Role: primary
References
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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004-2022
Identifier Type: -
Identifier Source: org_study_id
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