AzTrials
AzTrials

Anxiety DisordersNCT05637320

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

A study testing Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems in people with Anxiety Disorders and Depressive Disorder, run by University of Guelph at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 8 to 15 years
What is being tested?
Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
2 sitesCanada
Study dates
1 Oct 2022to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Pun, BA contact

519-824-4120 ext. 53059

punj@uoguelph.ca

Canada2 sites, 2 recruiting

  • Maplewoods Centre for Family Therapy and Child Psychology

    Guelph, Ontario, N1G 2W1

    Kristel Thomassin, PhD, 519-824-4120 ext. 53059

    Recruiting

  • The Centre for Addition and Mental Health

    Toronto, Ontario

    Brendan Andrade, PhD

    Recruiting

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems
Keywords
Child psychotherapy, Emotion regulation, Physiology, Mechanism of change
Medical subject headings
Anxiety Disorders, Depressive Disorder, Mood Disorders, Conduct Disorder, Oppositional Defiant Disorder, Emotional Regulation, Child Behavior Disorders, Trauma and Stressor Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct ProblemsBehavioural

    Also called MATCH-ADTC

    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.

Study groups in NCT05637320
Study groupRoleWhat they receive
Intervention ArmExperimentalTreatment will be administered to participants in this arm.
Receives: Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems
Control ArmNo interventionNo treatment will be administered to participants in this arm until post-test assessment has been completed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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)

  2. 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).

    Measured: 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)

  3. 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.

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

  4. 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).

    Measured: 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)

  5. 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.

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

  6. 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.

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

  7. 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).

    Measured: 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)

  8. 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).

    Measured: 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)

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start1 Oct 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
202 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05637320
Sponsor's protocol ID
004-2022
Status last verified
Jan 2025
First submitted
15 Nov 2022
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 28295263

  • El-Sheikh M, Erath SA. Family conflict, autonomic nervous system functioning, and child adaptation: state of the science and future directions. Dev Psychopathol. 2011 May;23(2):703-21. doi: 10.1017/S0954579411000034.

    PubMed 23786705

  • McLaughlin KA, Alves S, Sheridan MA. Vagal regulation and internalizing psychopathology among adolescents exposed to childhood adversity. Dev Psychobiol. 2014 Jul;56(5):1036-51. doi: 10.1002/dev.21187. Epub 2013 Dec 11.

    PubMed 24338154

  • Lahey BB, Krueger RF, Rathouz PJ, Waldman ID, Zald DH. A hierarchical causal taxonomy of psychopathology across the life span. Psychol Bull. 2017 Feb;143(2):142-186. doi: 10.1037/bul0000069. Epub 2016 Dec 22.

    PubMed 28004947

  • Haltigan JD, Aitken M, Skilling T, Henderson J, Hawke L, Battaglia M, Strauss J, Szatmari P, Andrade BF. "P" and "DP:" Examining Symptom-Level Bifactor Models of Psychopathology and Dysregulation in Clinically Referred Children and Adolescents. J Am Acad Child Adolesc Psychiatry. 2018 Jun;57(6):384-396. doi: 10.1016/j.jaac.2018.03.010. Epub 2018 Apr 10.

    PubMed 29859554

  • Aitken M, Battaglia M, Marino C, Mahendran N, Andrade BF. Clinical utility of the CBCL Dysregulation Profile in children with disruptive behavior. J Affect Disord. 2019 Jun 15;253:87-95. doi: 10.1016/j.jad.2019.04.034. Epub 2019 Apr 9.

    PubMed 31029857

  • Bird HR, Canino GJ, Davies M, Ramirez R, Chavez L, Duarte C, Shen S. The Brief Impairment Scale (BIS): a multidimensional scale of functional impairment for children and adolescents. J Am Acad Child Adolesc Psychiatry. 2005 Jul;44(7):699-707. doi: 10.1097/01.chi.0000163281.41383.94.

    PubMed 15968239

  • Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.

    PubMed 30657721

Questions about this trial

What is this clinical trial studying?

A study testing Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems in people with Anxiety Disorders and Depressive Disorder, run by University of Guelph at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessica Pun, BA (519-824-4120 ext. 53059, punj@uoguelph.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05637320, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.

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