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

Anxiety Disorders Clinical Trial

Official title:

Biobehavioural Regulation of Negative Emotion as a Transdiagnostic Mechanism of Children's Psychotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637320
• Other study ID #: 004-2022
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: University of Guelph
• Contact: Jessica Pun, BSc
• Phone: 519-824-4120
• Email: punj[@]uoguelph.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Child Behavior Disorders
• Conduct Disorder
• Depressive Disorder
• Mental Disorders
• Mood Disorders
• Oppositional Defiant Disorder
• Trauma and Stressor Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	Maplewoods Centre for Family Therapy and Child Psychology	Guelph	Ontario
Canada	The Centre for Addition and Mental Health	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Guelph	Canadian Institutes of Health Research (CIHR), Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at follow up (1 year after post-test completion)
Primary	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 at follow up (1 year after post-test completion)
Primary	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 at follow up (1 year after post-test completion)
Primary	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 at follow up (1 year after post-test completion)
Primary	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 at follow up (1 year after post-test completion)
Primary	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 at follow up (1 year after post-test completion)
Primary	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 at follow up (1 year after post-test completion)
Primary	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), change at follow up (1 year after post-test completion)
Secondary	Change in child psychopathology symptoms on a weekly basis	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	From pre-test assessment to post-test assessment, an average of 4 - 6 months
Secondary	Change in child emotion regulation on a weekly basis	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.	From pre-test assessment to post-test assessment, an average of 4 - 6 months
Secondary	Change in parent psychopathology symptoms	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 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)
Secondary	Change in parent stress	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 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)
Secondary	Change in parent emotion regulation	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 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)
Secondary	Change in family function	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 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)
Secondary	Change in family organization	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 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)
Secondary	Change in parenting	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 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)
Secondary	Change in child trauma symptoms	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 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)
Secondary	Change in child positive and negative affect	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).	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)