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

NCT05637320 | Recruiting

• 1 other identifier: 004-2022
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (8)

• Change in parent-rated child psychopathology symptoms

  This outcome will be measured through the Child Behavior Checklist (CBCL), a 113-item measure of child psychopathology symptoms that is completed by parents (parent-report). Parents will rate items on a three-point Likert scale from (0 = Never, 1 = Sometimes, 2 = Often) with scores across syndrome scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, and aggressive behaviours) and DSM-oriented scales (affective problems, anxiety problems, somatic problems, attention-deficit/hyperactivity problems, oppositional defiant problems, and conduct problems).

  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)

• Change in child self-reported psychopathology symptoms

  This outcome will be measured through the Youth Self Report (YSR) a 112-item measure of child psychopathology symptoms that is completed by children aged 11 - 15 (youth-report). Children will rate items on a three-point Likert scale from (0 = Never, 1 = Sometimes, 2 = Often) with scores across syndrome scales (anxious/depressed, withdrawn/depressed, somatic problems, social problems, thought problems, rule-breaking behaviour, and aggressive behaviours) and DSM-oriented scales (depressive problems, anxiety problems, somatic problems, attention-deficit/hyperactivity problems, oppositional defiant problems, and conduct problems).

  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)

• Change in child psychopathology symptoms (past week)

  This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem) with greater scores (internalizing subscale range = 0-24; externalizing subscale range = 0-24; total score range = 0-48) indicating more severe psychopathology. The BFS generates Internalizing, Externalizing, and Total Problems scores.

  Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)

• Change in child emotional-behavioural problems

  This outcome will be measured through the Top Problems Assessment (TPA), a brief, clinical interview that is completed by parents (parent-report) and children (youth-report). Children and parents will identify and describe one to three primary issues, rate the severity of each problem on a scale of 0 (not a problem) to 4 (a very big problem). They will then rank order the problems from 1 (biggest problem) to 3 (least big problem).

  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)

• Change in child impairment

  This outcome will be measured through the Brief Impairment Scale (BIS), a 23-item measure of child impairment that is completed by one or both parents (parent-report). Parents will rate items on a four-point Likert scale from 0 (No problem) to 3 (A Serious Problem) with greater scores across three domains (interpersonal subscale = 0 - 24, school/work = 0 - 24, self-fulfillment = 0 - 24) indicating more severe impairment.

  Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)

• Change in ratings of child emotion regulation

  This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report for children). Parents and children will rate the items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7 - 28) indicating poorer emotion regulation.

  Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)

• Change in child physiological emotion regulation (heart rate variability)

  This outcome will be measured by child heart rate variability during the completion of lab tasks (Modified Trier Social Stress Test for Children, Piñata Task, Cognitive Reappraisal, Parent-Child Conflict Discussion).

  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)

• Change in child physiological emotion regulation (skin conductance)

  This outcome measure will be measured by child skin conductance level during the completion of lab tasks (Modified Trier Social Stress Test for Children, Piñata Task, Cognitive Reappraisal, Parent-Child Conflict Discussion).

  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 (10)

• Change in child psychopathology symptoms on a weekly basis

  From pre-test assessment to post-test assessment, an average of 4 - 6 months

• Change in child emotion regulation on a weekly basis

  From pre-test assessment to post-test assessment, an average of 4 - 6 months

• Change in parent psychopathology symptoms

  Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)

• Change in parent stress

  Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)

• Change in parent emotion regulation

  Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Treatment will be administered to participants in this arm.

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

Control Arm

NO INTERVENTION

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

Interventions

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

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.

Also known as: MATCH-ADTC

Intervention Arm

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guelph: lead
• Centre for Addiction and Mental Health: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Maplewoods Centre for Family Therapy and Child Psychology

Guelph, Ontario, N1G 2W1, Canada

RECRUITING

The Centre for Addition and Mental Health

Toronto, Ontario, Canada

RECRUITING

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MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Mood Disorders; Conduct Disorder; Oppositional Defiant Disorder; Emotional Regulation; Child Behavior Disorders; Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Kristel Thomassin, PhD

  University of Guelph

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Pun, BA

CONTACT

519-824-4120; punj@uoguelph.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 5, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)