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

University of Guelph

Status: Enrolling

Conditions: Oppositional Defiant Disorder; Conduct Disorder; Trauma and Stressor Related Disorders; Regulation, Emotion; Mood Disorders; Anxiety Disorders; Depressive Disorder; Child Behavior Disorders

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05637320

004-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 202 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Treatment will be administered to participants in this arm.

Treatment:

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

Control Arm

No Intervention group

Description:

No treatment will be administered to participants in this arm until post-test assessment has been completed.