Biobehavioural Regulation of Negative Emotion as a Transdiagnostic Mechanism of Children's Psychotherapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anxiety Disorders
- Sponsor
- University of Guelph
- Enrollment
- 202
- Locations
- 2
- Primary Endpoint
- Change in parent-rated child psychopathology symptoms
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Kristel Thomassin
Associate Professor
University of Guelph
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
Outcomes
Primary Outcomes
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)
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 psychopathology symptoms (past week)
Time Frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 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. 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)
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)
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)
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 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)
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 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)
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)
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).
Secondary Outcomes
- Change in child positive and negative affect(Change at post-test (after completion of the waitlist or intervention treatment; an average range 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 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))
- Change in family function(Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months))
- Change in parenting(Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months))
- Change in child trauma symptoms(Change at post-test (after completion of the waitlist or intervention treatment; an average range 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 family organization(Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months))
- Change in child psychopathology symptoms on a weekly basis(From pre-test assessment to post-test assessment, an average of 4 - 6 months)