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Recruiting NCT05637320

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

No phase Interventional Anxiety Disorders Depressive Disorder Mood Disorders Conduct Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems.
Who it may be relevant to
Registry conditions: Anxiety Disorders, Depressive Disorder, Mood Disorders, Conduct Disorder. Basic parameters: 8 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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 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 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 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 in child impairment [Time frame: 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 [Time frame: 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) [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 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)]
Secondary outcome measures (10)
  • 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]
  • 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]
  • 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 in parent stress [Time frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)]
  • 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 in family function [Time frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)]
  • 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 in parenting [Time frame: Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months)]
  • 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 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • Maplewoods Centre for Family Therapy and Child Psychology — Guelph
  • The Centre for Addition and Mental Health — Toronto

Publications

  • Weisz JR, Kuppens S, Ng MY, Eckshtain D, Ugueto AM, Vaughn-Coaxum R, Jensen-Doss A, Hawley KM, Krumholz Marchette LS, Chu BC, Weersing VR, Fordwood SR. What five decades of research tells us about the effects of youth psychological therapy: A multilevel meta-analysis and implications for science and practice. Am Psychol. 2017 Feb-Mar;72(2):79-117. doi: 10.1037/a0040360. PMID 28221063
  • Kreibig SD. Autonomic nervous system activity in emotion: a review. Biol Psychol. 2010 Jul;84(3):394-421. doi: 10.1016/j.biopsycho.2010.03.010. Epub 2010 Apr 4. PMID 20371374
  • Sloan E, Hall K, Moulding R, Bryce S, Mildred H, Staiger PK. Emotion regulation as a transdiagnostic treatment construct across anxiety, depression, substance, eating and borderline personality disorders: A systematic review. Clin Psychol Rev. 2017 Nov;57:141-163. doi: 10.1016/j.cpr.2017.09.002. Epub 2017 Sep 11. PMID 28941927
  • Fergusson DM, Woodward LJ. Mental health, educational, and social role outcomes of adolescents with depression. Arch Gen Psychiatry. 2002 Mar;59(3):225-31. doi: 10.1001/archpsyc.59.3.225. PMID 11879160
  • Masten AS, Roisman GI, Long JD, Burt KB, Obradovic J, Riley JR, Boelcke-Stennes K, Tellegen A. Developmental cascades: linking academic achievement and externalizing and internalizing symptoms over 20 years. Dev Psychol. 2005 Sep;41(5):733-746. doi: 10.1037/0012-1649.41.5.733. PMID 16173871
  • Masi G, Muratori P, Manfredi A, Lenzi F, Polidori L, Ruglioni L, Muratori F, Milone A. Response to treatments in youth with disruptive behavior disorders. Compr Psychiatry. 2013 Oct;54(7):1009-15. doi: 10.1016/j.comppsych.2013.04.007. Epub 2013 May 14. PMID 23683839
  • Hollenstein T, McNeely A, Eastabrook J, Mackey A, Flynn J. Sympathetic and parasympathetic responses to social stress across adolescence. Dev Psychobiol. 2012 Mar;54(2):207-14. doi: 10.1002/dev.20582. Epub 2011 Jun 17. PMID 21688260
  • Davis M, Thomassin K, Bilms J, Suveg C, Shaffer A, Beach SRH. Preschoolers' genetic, physiological, and behavioral sensitivity factors moderate links between parenting stress and child internalizing, externalizing, and sleep problems. Dev Psychobiol. 2017 May;59(4):473-485. doi: 10.1002/dev.21510. Epub 2017 Mar 14. PMID 28295263

Identifiers

NCT: NCT05637320 · 004-2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗