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

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ClinicalTrials.gov Identifier: NCT05637320
Recruitment Status : Recruiting
First Posted : December 5, 2022
Last Update Posted : March 19, 2024
Sponsor:
Collaborators:
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Kristel Thomassin, University of Guelph

Tracking Information
First Submitted Date  ICMJE November 15, 2022
First Posted Date  ICMJE December 5, 2022
Last Update Posted Date March 19, 2024
Actual Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date December 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2022)
  • Change in parent-rated child psychopathology symptoms [ Time Frame: 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 at follow up (1 year after post-test completion) ]
    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Likert scale from (0 = Never, 1 = Sometimes, 2 = Often) with scores across syndrome scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, and aggressive behaviours) and DSM-oriented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 in child self-reported psychopathology symptoms [ Time Frame: 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 at follow up (1 year after post-test completion) ]
    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Likert scale from (0 = Never, 1 = Sometimes, 2 = Often) with scores across syndrome scales (anxious/depressed, withdrawn/depressed, somatic problems, social problems, thought problems, rule-breaking behaviour, and aggressive behaviours) and DSM-oriented scales (depressive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 in child psychopathology symptoms (past week) [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    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 in child emotional-behavioural problems [ Time Frame: 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 at follow up (1 year after post-test completion) ]
    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 in child impairment [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    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 in ratings of child emotion regulation [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    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 in child physiological emotion regulation (heart rate variability) [ Time Frame: 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 at follow up (1 year after post-test completion) ]
    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 in child physiological emotion regulation (skin conductance) [ Time Frame: 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 at follow up (1 year after post-test completion) ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2022)
  • Change in child psychopathology symptoms on a weekly basis [ Time Frame: From pre-test assessment to post-test assessment, an average of 4 - 6 months ]
    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
  • Change in child emotion regulation on a weekly basis [ Time Frame: From pre-test assessment to post-test assessment, an average of 4 - 6 months ]
    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). 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 in parent psychopathology symptoms [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    This outcome will be measured through the Brief Symptom Inventory (BSI-18), an 18-item measure of adult psychopathology symptoms to be completed by parents (parent-report). Parents will rate items on a five-item Likert scale from 0 (Not at all) to 4 (Extremely) with greater scores on three dimensions (somatization, depression, anxiety, total score range = 0 - 72) indicating more severe psychopathology.
  • Change in parent stress [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    This outcome will be measured through the Parenting Stress Index-Short form (PSI-SF), a 36-item of stress in the parent-child relationship. Parents will rate items on a five-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree) with scores categorized into subscales (parental distress, parent-child dysfunctional interaction, and difficult child), and higher scores (range = 0 - 180) indicating greater stress.
  • Change in parent emotion regulation [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    This outcome will be measured through the Difficulties in Emotion Regulation Scale - Short Form (DERS), an 18-item self-report measure of emotion regulation difficulties to be completed by parents. Parents will indicate the frequency with which they experience difficulties with emotion regulation on a five-point Likert scale from 1 (Almost never) to 5 (Almost always), with greater total scores (range = 18 - 90) indicating greater difficulties with emotion regulation.
  • Change in family function [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    This outcome will be measured through the Family Functioning Style Scale (FFSS), a 26-item self-report measure of family function to be completed by parents. Parents will rate items on a five-point Likert scale from 0 (Not at all like my family) to 4 (Almost always like my family), with scores categorized into five subscales (interactional patterns, family values, coping strategies, family commitment and resource mobilization) of a family's functioning style
  • Change in family organization [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    This outcome will be measured using the Confusion, Hubbub, and Order Scale (CHAOS), a 15-item measure of family organization within the home, with 7 items reflecting routine and organization and 8 items reflecting disorganization and commotion. Parents will rate each item as true or false, with scores indicating higher or lower levels of chaos and disorganization.
  • Change in parenting [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    This outcome will be measured through the Coping with Children's Negative Emotions Scale (CCNES), a 12-item self-report measure of parental emotion parenting practices in response to children's expression of negative emotion. Responses are divided into six subscales representing six distinct types of parental responses. The responses will be grouped in two overall scores: Supportive (Expressive Encouragement, Problem-Focused, and Emotion-Focused Reactions) and Unsupportive (Punitive, Minimizing, and Distress Reactions) practices. Parents will rate the likelihood that they would respond in these distinct ways on a seven-point Likert scale from 1 (Very unlikely) to 7 (Very likely), with greater overall scores (range = 1-7) indicating greater levels of each type of parental response.
  • Change in child trauma symptoms [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    This outcome will be measured with the Child and Adolescent Trauma Screener (CATS), a 15-item screener of the occurrence of traumatic events, and 25-items of trauma symptoms. Parents will rate items on a four-point Likert scale from 0 (Never) to 3 (Almost always) with greater scores (range = 0 - 75) indicating more severe trauma symptoms.
  • Change in child positive and negative affect [ Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion) ]
    This outcome will be measured with the Positive and Negative Affect Scale (PANAS), a 20-item questionnaire consisting of single-word items describing positive (e.g. excited) and negative (e.g. scared) feelings. Each item is rated on a 5-point scale (1 = Very slightly or not at all; 5 = Extremely).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Big Feelings: A Study on Children's Emotions in Therapy
Official Title  ICMJE Biobehavioural Regulation of Negative Emotion as a Transdiagnostic Mechanism of Children's Psychotherapy
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.

Participants in the control condition will complete a follow up assessment after their completion of usual care (should they receive usual care), and participants in the intervention condition will complete a follow up assessment 1-year after their completion of treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety Disorders
  • Depressive Disorder
  • Mood Disorders
  • Conduct Disorder
  • Oppositional Defiant Disorder
  • Regulation, Emotion
  • Child Behavior Disorders
  • Trauma and Stressor Related Disorders
Intervention  ICMJE Behavioral: 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 Name: MATCH-ADTC
Study Arms  ICMJE
  • Experimental: Intervention Arm
    Treatment will be administered to participants in this arm.
    Intervention: Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems
  • No Intervention: Control Arm
    No treatment will be administered to participants in this arm until post-test assessment has been completed.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2024)
202
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2022)
404
Estimated Study Completion Date  ICMJE December 31, 2027
Estimated Primary Completion Date December 31, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica Pun, BSc 519-824-4120 ext 53059 punj@uoguelph.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05637320
Other Study ID Numbers  ICMJE 004-2022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kristel Thomassin, University of Guelph
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Guelph
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Centre for Addiction and Mental Health
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Kristel Thomassin, PhD University of Guelph
PRS Account University of Guelph
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP