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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06373484
Other study ID # 018-2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date September 2027

Study information

Verified date April 2024
Source Centre for Addiction and Mental Health
Contact Brendan F. Andrade, PhD
Phone 416-535-8501
Email brendan.andrade@camh.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 2027
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. — View 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. — View 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.

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

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.

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. — View 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. — View 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.

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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
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