NCT07495683

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 (BPT).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Status
completed

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 Start

First participant enrolled

September 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2024

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

June 28, 2024

Last Update Submit

March 24, 2026

Conditions

Keywords

Disruptive Behaviour DisorderAttention Deficit Hyperactivity DisorderConduct DisorderOppositional Defiant DisorderParenting SkillsBehavioural Parenting Training

Outcome Measures

Primary Outcomes (3)

  • Changes in child emotional and behavioral problems between baseline, post-treatment, and follow-up

    Changes in child emotional and behavioral problems are assessed using the Strengths and Difficulties Questionnaire (SDQ). It 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'.

    Baseline (prior to treatment), post-treatment (within 30 days post-intervention completion) and follow-up (1 year post-treatment completion)

  • Changes in parenting skills between baseline, post-treatment, and follow-up

    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'. Each answer corresponds to a score: never = 1, almost never = 2, sometimes = 3, often = 4, and always = 5. The APQ has 3 subscales: positive parenting, inconsistent discipline, and poor supervision. Higher scores on the positive parenting subscale means greater positive parenting skills. Higher scores on the inconsistent discipline subscale means greater instances of inconsistent discipline. Higher scores on the poor supervision subscale means greater instances of poor supervision.

    Baseline (prior to treatment), post-treatment (within 30 days of treatment completion) and follow-up (1 year after treatment completion)

  • Changes in parenting competencies between baseline, post-treatment, and follow-up

    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'. Higher scores on the PSOC indicate higher parenting sense of competence with scores ranging from a minimum of 17 and a maximum of 102.

    Baseline (prior to treatment), post-treatment (within 30 days of treatment completion) and follow-up (1 year after treatment completion)

Secondary Outcomes (3)

  • Changes in child emotional and behavioural challenges between baseline, post-treatment, and follow-up

    Baseline (prior to treatment), post-treatment (within 30 days of treatment completion) and follow-up (1 year after treatment completion)

  • Changes in child emotional and behavioural challenges between baseline, post-treatment, and follow up

    Baseline (prior to treatment), post-treatment (within 30 days of treatment completion) and follow-up (1 year after treatment completion)

  • Changes in child emotional and behavioural challenges between baseline, post-treatment, and follow up

    Baseline (prior to treatment), post-treatment (within 30 days of treatment completion) and follow-up (1 year after treatment completion)

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:

  • Diagnosis of Oppositional Defiant Disorder (ODD), Conduct Disorder (CD) or Attention Deficit Hyperactivity Disorder (ADHD) determined by the supervising Clinical Psychologist based on DSM-5 diagnostic criteria on the C-DISC; and/or clinically at risk symptoms on the Child Behavior Checklist/Teacher Report Form (t score \> 60)
  • Clinically severe impairment in social, family, peer functioning demonstrated by the parent- and teacher-completed Impairment Rating Scale (IRS) or the virtually administered Columbia Impairment Scale (CIS)
  • No evidence of Autism Spectrum Disorder (based on parent and teacher report) or Intellectual Disability (based on the Kaufman Brief Intelligence Task-II OR school reports or psychoeducational assessments).

You may not qualify if:

  • Presence of Autism or Intellectual Disability
  • Evidence of cognitive delays or an intellectual disability (based on the Kaufman 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

Related Publications (4)

  • Lochman JE, Wells KC. The coping power program for preadolescent aggressive boys and their parents: outcome effects at the 1-year follow-up. J Consult Clin Psychol. 2004 Aug;72(4):571-8. doi: 10.1037/0022-006X.72.4.571.

    PMID: 15301641BACKGROUND
  • 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 and individualized child and family treatment: A randomized and controlled effectiveness trial. Journal of Child Psychology and Psychiatry, 2015. Submitted.

    BACKGROUND
  • Lochman JE, Powell N, Boxmeyer C, Andrade B, Stromeyer SL, Jimenez-Camargo LA. Adaptations to the coping power program's structure, delivery settings, and clinician training. Psychotherapy (Chic). 2012 Jun;49(2):135-42. doi: 10.1037/a0027165.

    PMID: 22642521BACKGROUND

MeSH Terms

Conditions

Mental DisordersAttention Deficit and Disruptive Behavior DisordersAttention Deficit Disorder with HyperactivityConduct DisorderOppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders

Study Officials

  • Brendan F. Andrade, Dr.

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 28, 2024

First Posted

March 27, 2026

Study Start

September 1, 2016

Primary Completion

September 1, 2022

Study Completion

July 1, 2023

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Would need further REB approval to determine whether participant data could be released based on existing consent.