NCT06373484

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Oct 2022Sep 2027

Study Start

First participant enrolled

October 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

January 17, 2024

Last Update Submit

March 16, 2026

Conditions

Keywords

Emotional and Behavioural DisordersDisruptive Behaviour DisorderAttention Deficit Hyperactivity DisorderConduct DisorderOppositional Defiant DisorderParenting SkillsBehavioural Parenting Training

Outcome Measures

Primary Outcomes (3)

  • Changes in parenting skills between baseline, post-treatment, and follow-up (6 months - 1 year)

    Parenting skills are assessed using the Alabama Parenting Questionnaire (APQ). Parents indicate how often an item typically occurs in their home: 'never', 'almost never', 'sometimes', 'often', or 'always'.

    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)

    Parenting competencies are assessed using the Parenting Sense of Competence (PSOC). Parents indicate how much they agree with statements: 'strongly disagree', 'disagree', 'slightly disagree', 'slightly agree', 'agree', or 'strongly agree'.

    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)

    Child emotional and behavioral problems are assessed using the Strengths and Difficulties Questionnaire (SDQ), Behavior and Feelings Scale (BFS), Child Behavior Checklist (CBCL), and the Modified Connors. The SDQ asks asks parents to indicate how true a statement is with regards to their child's emotions or behaviours in the last 6 months: 'not true', 'somewhat true', or 'certainly true'. The BFS asks parents to indicate how big of a problem a behaviour or feeling has been for a child in the last two weeks from '0 - not a problem' to '4 - a very big problem'. The CBCL asks parents to indicate how relevant the listed challenges are to their child from '0 - not true', '1 - somewhat or sometime true', and '2 - very or often true'. The Modified Connors asks parents to indicate how much a concerning behaviour describes their child from 'not at all', 'just a little', 'pretty much', or 'very much'.

    Baseline and post-treatment and follow-up (6 months - 1 year)

Study Arms (1)

Multi-Component Child and Parent Cognitive Behavioral Therapy

EXPERIMENTAL

Parents and their children aged 6-12 with DBD who meet inclusion criteria.

Behavioral: Behavioral Parent Training

Interventions

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).

Multi-Component Child and Parent Cognitive Behavioral Therapy

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

Related Publications (10)

  • 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: 25257946BACKGROUND
  • 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: 29594940BACKGROUND
  • 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: 28500434BACKGROUND
  • 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: 28696032BACKGROUND
  • 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.

    BACKGROUND
  • Andrade, B.F., et al., The clinic adapted coping power program compared to individualized treatment; A randomized and controlled efficacy trial. 2018. In Progress.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 33598852BACKGROUND

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior DisordersMental DisordersAttention Deficit Disorder with HyperactivityConduct DisorderOppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders

Study Officials

  • Brendan F. Andrade, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brendan F. Andrade, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

April 18, 2024

Study Start

October 1, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available following publication for up to one year.
Access Criteria
Information will be shared with qualified investigators at the discretion of the principal investigator.

Locations