An interventional study of Parent Management Training and Tuning Your Temper in Oppositional Defiant Disorder, sponsored by University of Iceland. Recruiting at 1 site in Iceland. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-08.
Sponsored by University of Iceland · Not applicable, Interventional, and Treatment
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.
86 studies on the registry are indexed under Oppositional Defiant Disorder; 16 are open to participants now.
This study's planned enrollment of 196 is above the median of 102 across 76 interventional studies indexed under Oppositional Defiant Disorder.
Browse Oppositional Defiant Disorder studies →University of Iceland is the lead sponsor of 35 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral parent training intervention. Individual sessions.
Behavioral: Parent Management Training
Child directed cognitive behavioral therapy. Individual sessions.
Behavioral: Tuning Your Temper
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.
Disruptive 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.
Plan to share: No — As the study includes repeated measures of a vulnerable population, parts of the data will be classified as sensitive personal data and thus restricted by the permit from the Bioethics Committee. We will consult with GAGNÍS (member of CESSDA ERIC) on how to make the data available according to the FAIR principles.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 months after the start.
Of 35 non-industry interventional studies with no phase under Oppositional Defiant Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 47 months is above that.
Counting every sponsor, half of 36 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Oppositional Defiant Disorder →
University of Iceland