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Recruiting NCT06373484

Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents

No phase Interventional Disruptive Behavior Disorder Emotional Disorder Behavioural Disorder Attention Deficit Hyperactivity 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: Behavioral Parent Training.
Who it may be relevant to
Registry conditions: Disruptive Behavior Disorder, Emotional Disorder, Behavioural Disorder, Attention Deficit Hyperactivity Disorder. Basic parameters: 6 years — 12 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 →

Overview

This study will develop and test whether personalized profiles of children with Disruptive Behaviour Disorder (DBD) and their parents based on important psychological, emotional, and neuropsychological indicators predict their response to child cognitive behavioral treatment and Behavioral Parent Training.

Detailed description

To accomplish these goals, the investigators will collect psychological, emotional, and neuropsychological measures before and following cognitive behavioural therapy (CBT) for both children and parents. The investigators will use statistical modeling to determine profiles of parents of children and children aged 6-12 years with DBD based on key domains of mental health, emotion regulation, cognition, and parent-child behaviour, and observe whether these profiles allow the study team to predict which sub-groups of parents and children are most and least likely to benefit from child CBT and Behavioural Parent Training (BPT).

Interventions

  • Behavioral Behavioral Parent Training
    Two 15-session multi-component cognitive-behavioral group treatments for children with disruptive behavior and their parents (i.e., one program for children aged 6-8 years and their parents and another for children aged 9-12 years and their parents. The programs have a child and parent group that are implemented concurrently).

Primary outcome measures

  • Changes in parenting skills between baseline, post-treatment, and follow-up (6 months - 1 year) [Time frame: Baseline and post-treatment and follow-up (6 months - 1 year)]
  • Changes in parenting competencies between baseline, post-treatment, and follow-up (6 months - 1 year) [Time frame: Baseline and post-treatment and follow-up (6 months - 1 year)]
  • Changes in child emotional and behavioral problems between baseline, post-treatment, and follow-up (6 months - 1 year) [Time frame: Baseline and post-treatment and follow-up (6 months - 1 year)]

Eligibility criteria

Inclusion criteria

  • Child is borderline/clinically at risk on the Child Behaviour Checklist (CBCL) or Teacher Report Form (TRF) (T-score greater than or equal to 60 on Externalizing Problems composite scale or a T-score greater than or equal to 65 on the Oppositional Defiant Disorder and/or Conduct Disorder scales)
  • Child has clinically severe impairment in the interpersonal relations (greater than 3), functioning in schoolwork (greater than 3), or total domains (greater than 15) on the Columbia Impairment scale.
  • Parent is able and willing to participate in a group treatment

Exclusion criteria

  • Child has an ongoing query or diagnosis of Pervasive Developmental Disorder or Autism or Asperger's Disorder
  • Evidence of cognitive delays or an intellectual disability (based on the Kauffman Brief Intelligence Test-2 (KBIT-2), verbal and/or IQ composite standard score below 80 or collateral information)
  • Child behaviour or emotional functioning that make group participation not possible
  • Child preference for individual treatment.
  • Parent behaviour or emotional functioning that make group participation not possible
  • Parent preference for individual treatment.

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre for Addiction and Mental Health — Toronto

Publications

  • Andrade BF, Sorge GB, Na JJ, Wharton-Shukster E. Clinical Profiles of Children with Disruptive Behaviors Based on the Severity of Their Conduct Problems, Callous-Unemotional Traits and Emotional Difficulties. Child Psychiatry Hum Dev. 2015 Aug;46(4):567-76. doi: 10.1007/s10578-014-0497-8. PMID 25257946
  • Aitken M, Waxman JA, MacDonald K, Andrade BF. Effect of Comorbid Psychopathology and Conduct Problem Severity on Response to a Multi-component Intervention for Childhood Disruptive Behavior. Child Psychiatry Hum Dev. 2018 Dec;49(6):853-864. doi: 10.1007/s10578-018-0800-1. PMID 29594940
  • Ludmer JA, Sanches M, Propp L, Andrade BF. Comparing the Multicomponent Coping Power Program to Individualized Parent-Child Treatment for Improving the Parenting Efficacy and Satisfaction of Parents of Children with Conduct Problems. Child Psychiatry Hum Dev. 2018 Feb;49(1):100-108. doi: 10.1007/s10578-017-0732-1. PMID 28500434
  • Leijten P, Gardner F, Landau S, Harris V, Mann J, Hutchings J, Beecham J, Bonin EM, Scott S. Research Review: Harnessing the power of individual participant data in a meta-analysis of the benefits and harms of the Incredible Years parenting program. J Child Psychol Psychiatry. 2018 Feb;59(2):99-109. doi: 10.1111/jcpp.12781. Epub 2017 Jul 11. PMID 28696032
  • Lochman, J.E. and K.C. Wells, Effectiveness of the Coping Power Program and of Classroom Intervention With Aggressive Children: Outcomes at a 1-Year Follow-Up. Behavior Therapy, 2003. 34: p. 493-515.
  • Andrade, B.F., et al., The clinic adapted coping power program compared to individualized treatment; A randomized and controlled efficacy trial. 2018. In Progress.
  • Lochman, J.E. and K.C. Wells, Effectiveness of the Coping Power Program and of classroom intervention with aggressive children: Outcomes at 1-year follow-up. Behavior Therapy, 2003. 34(4): p. 493-515.
  • Andrade, B.F., et al., The clinic-adapted coping power program and individualized child and family treatment: A randomized and controlled effectiveness trial. In preparation, 2015.

Identifiers

NCT: NCT06373484 · 018-2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗