Clinical trial NCT05637320: Big Feelings: A Study on Children's Emotions in Therapy
Official title: Biobehavioural Regulation of Negative Emotion as a Transdiagnostic Mechanism of Children's Psychotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Mood Disorders
Conduct Disorder
Oppositional Defiant Disorder
Regulation, Emotion
Child Behavior Disorders
Trauma and Stressor Related Disorders
Keywords: Child psychotherapy
Emotion regulation
Physiology
Mechanism of change
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-12-05
Enrollment: 202
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled trial, consisting of an intervention arm and a control arm, which will occur concurrently. Participants will be continually enrolled in the study until 202 parent-child dyads are recruited.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in parent-rated child psychopathology symptoms
timeFrame: Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in child self-reported psychopathology symptoms
timeFrame: Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in child psychopathology symptoms (past week)
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in child emotional-behavioural problems
timeFrame: Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in child impairment
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in ratings of child emotion regulation
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in child physiological emotion regulation (heart rate variability)
timeFrame: Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in child physiological emotion regulation (skin conductance)
timeFrame: Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
Secondary outcomes:
measure: Change in child psychopathology symptoms on a weekly basis
timeFrame: From pre-test assessment to post-test assessment, an average of 4 - 6 months
measure: Change in child emotion regulation on a weekly basis
timeFrame: From pre-test assessment to post-test assessment, an average of 4 - 6 months
measure: Change in parent psychopathology symptoms
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in parent stress
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in parent emotion regulation
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in family function
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in family organization
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in parenting
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in child trauma symptoms
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
measure: Change in child positive and negative affect
timeFrame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Maplewoods Centre for Family Therapy and Child Psychology
state: Ontario
city: Toronto
country: Canada
facility: The Centre for Addition and Mental Health
state: Ontario
Study officials:
affiliation: University of Guelph
name: Kristel Thomassin, PhD
role: PRINCIPAL_INVESTIGATOR
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