The goal of this randomized controlled trial is to is to test emotion regulation as a moderator of two different treatments for children with Oppositional Defiant Disorder (ODD). The main question it aims to answer is whether treatment gains be increased when children with ODD receive a treatment congruent with their emotion regulation skill problems. Participants will be divided into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills.
Emotion regulation has been implicated in the development of ODD. Two types of treatment are commonly used for children with ODD, behavioral parent training and child directed cognitive treatments. Parent training focuses on increasing compliance and reducing defiant behaviour while the child directed treatments focus on increasing the child's problem solving skills and emotion regulation. The investigators will assess emotion regulation and emotional lability in children diagnosed with ODD and divide them into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills, which makes it possible to assess the effects of the different interventions for the two distinct groups. Treatment effects will be assessed at pre- and post-treatment as well as at 6 and 18 month follow-up. Comorbid conditions will be tested as moderators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
196
Behavioral parent training program aimed at increasing compliance and positive behaviours while decreasing disruptive behaviours
Cognitive behavioural treatment for children focusing on arousal reduction, problem solving and cognitive restructuring.
University of Iceland
Reykjavik, Iceland
RECRUITINGDisruptive Behaviour Rating Scale
Parent and teacher rated questionnaire to assess change in symptoms of ODD.
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
Diagnostic Interview to assess whether a child changes in diagnostic status, whether child meets DSM-5 diagnostic criteria for mental disorders.
Time frame: Pre-treatment; 6-month follow-up; 18-month follow-up.
Strength and difficulties questionnaire
Parent and teacher rated questionnaire to assess change in emotional and behavioral problems. Results are converted to t-scores where t=65 is considered a clinical cut-off score. Higher scores indicate worse outcome.
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Home Situations Questionnaire
Parent rated questionnaire to assess change in compliance and problematic behaviour at home. Frequency of problems is recorded (min 0, max 16) and severity score for each item endorsed is rated on the scale of 0-9 with higher scores indicating worse outcome.
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Social Skills Rating System
Parent rated questionnaire to assess change in social skills. The SSRS has 55 questions rated from 0-2 (min 0 max 110). There are 4 social skills domains: Cooperation, Assertion, Responsibility and Self-control with higher scores indicating better outcome. And 3 problem domains (External, Internal and Hyperactivity) with higher scores indicating worse outcome.
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Parent Stress Index
Parent rated questionnaire to assess change in parental stress. Scores range from 18-90 with higher scores indicating higher levels of parental stress.
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Pediatric Quality of Life Index
Questionnaire to assess change in child quality of life. The parent version used has 23 items rated on a scale from 0-4 (min 0 max 92). High scores indicate worse outcome.
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.