Recruiting

Children's Emotions

Sponsor:

University of Guelph

Code:

NCT05637320

Conditions

Anxiety Disorders

Depressive Disorder

Mood Disorders

Conduct Disorder

Oppositional Defiant Disorder

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Anxiety Disorders

Depressive Disorder

Mood Disorders

Conduct Disorder

Oppositional Defiant Disorder

Study ID

NCT05637320

Start date

Oct 1, 2022

Status verified date

Jan, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

202 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Treatment will be administered to participants in this arm.

no intervention: Control Arm

No treatment will be administered to participants in this arm until post-test assessment has been completed.

Interventions

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.

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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Jessica Pun, BA

519-824-4120punj@uoguelph.ca

Locations

Maplewoods Centre for Family Therapy and Child Psychology

Recruiting

Guelph, Ontario, Canada, N1G 2W1

Contacts

Kristel Thomassin, PhD

519-824-4120

The Centre for Addition and Mental Health

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

University of Guelph

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Keywords

  • Child psychotherapy
  • Emotion regulation
  • Physiology
  • Mechanism of change

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Guelph on 2025-01-29.