Clinical trial NCT06373484: Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents
Official title: Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disruptive Behavior Disorder
Emotional Disorder
Behavioural Disorder
Attention Deficit Hyperactivity Disorder
Conduct Disorder
Oppositional Defiant Disorder
Keywords: Emotional and Behavioural Disorders
Disruptive Behaviour Disorder
Attention Deficit Hyperactivity Disorder
Conduct Disorder
Oppositional Defiant Disorder
Parenting Skills
Behavioural Parenting Training
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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.

Primary outcomes:
measure: Changes in parenting skills between baseline, post-treatment, and follow-up (6 months - 1 year)
timeFrame: Baseline and post-treatment and follow-up (6 months - 1 year)
measure: Changes in parenting competencies between baseline, post-treatment, and follow-up (6 months - 1 year)
timeFrame: Baseline and post-treatment and follow-up (6 months - 1 year)
measure: Changes in child emotional and behavioral problems between baseline, post-treatment, and follow-up (6 months - 1 year)
timeFrame: Baseline and post-treatment and follow-up (6 months - 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Brendan F. Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Andrade, B.F., et al., The clinic adapted coping power program compared to individualized treatment; A randomized and controlled efficacy trial. 2018. In Progress.
citation: 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.
citation: 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.
citation: Andrade, B.F., et al., Implementation and evaluation of an evidence-based treatment for disruptive behaviour within a children's mental health program. Canadian Journal of Program Evaluation, 2015. 2015, 30(2): p. 195-204.
citation: Kil H, Aitken M, Henry S, Hoxha O, Rodak T, Bennett K, Andrade BF. Transdiagnostic Associations Among Parental Causal Locus Attributions, Child Behavior and Psychosocial Treatment Outcomes: A Systematic Review. Clin Child Fam Psychol Rev. 2021 Jun;24(2):267-293. doi: 10.1007/s10567-020-00341-1. Epub 2021 Feb 18.