About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosed with Oppositional Defiant Disorder
Icelandic speaking (child and parent/guardian)
Disqualifiers
IQ below 70 (full scale score)
Trial design
Parallel
Treatments tested in this trial
Parent Management Training
BehavioralBehavioral parent training program aimed at increasing compliance and positive behaviours while decreasing disruptive behaviours
Tuning Your Temper
BehavioralCognitive behavioural treatment for children focusing on arousal reduction, problem solving and cognitive restructuring.
Treatment groups
Trial outcomes
Primary outcomes
Disruptive Behaviour Rating Scale
Parent and teacher rated questionnaire to assess change in symptoms of ODD.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Iceland
Lead sponsor
Stockholm University
Collaborator