Big Feelings: A Study on Children's Emotions in Therapy

Last updated: January 27, 2025
Sponsor: University of Guelph
Overall Status: Active - Recruiting

Phase

N/A

Condition

Panic Disorders

Mood Disorders

Anxiety Disorders

Treatment

Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems

Clinical Study ID

NCT05637320
004-2022
  • Ages 8-15
  • All Genders

Study 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

Inclusion Criteria:

  • Child must be between the ages of 8 and 15 years old and have English proficiency

  • 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

Exclusion Criteria:

  • Child has low cognitive functioning that would prevent active participation inresearch tasks

  • Child reports active suicidality that requiring acute care or hospital intervention

  • Child meets criteria for psychosis, schizophrenia spectrum disorders, eatingdisorders or autism spectrum disorders

  • Child does not assent to participate in the study

Study Design

Total Participants: 202
Treatment Group(s): 1
Primary Treatment: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
December 31, 2027

Study Description

Research shows that evidence-based psychotherapies for children's mental health problems are only moderately effective, and as many as 50% of children will fail to respond to treatment or will drop out of treatment. There is thus significant room for improvement. One way to improve outcomes for children and their families is to understand how psychotherapy works for children and to make personalized adjustments to optimize their effectiveness.

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.

Connect with a study center

  • Maplewoods Centre for Family Therapy and Child Psychology

    Guelph, Ontario N1G 2W1
    Canada

    Active - Recruiting

  • The Centre for Addition and Mental Health

    Toronto, Ontario
    Canada

    Active - Recruiting

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