Skip to main content
Clinical Trials/NCT06194994
NCT06194994
Recruiting
Not Applicable

Emotion Regulation as a Moderator of Two Different Treatments for Children With Oppositional Defiant Disorder: A Randomized Clinical Trial

University of Iceland1 site in 1 country196 target enrollmentJanuary 4, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oppositional Defiant Disorder
Sponsor
University of Iceland
Enrollment
196
Locations
1
Primary Endpoint
Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2024
End Date
December 2029
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Urdur Njardvik

Professor

University of Iceland

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Oppositional Defiant Disorder
  • Icelandic speaking (child and parent/guardian)

Exclusion Criteria

  • IQ below 70 (full scale score)

Outcomes

Primary Outcomes

Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)

Time Frame: Pre-treatment; 6-month follow-up; 18-month follow-up.

Diagnostic Interview to assess whether a child changes in diagnostic status, whether child meets DSM-5 diagnostic criteria for mental disorders.

Disruptive Behaviour Rating Scale

Time Frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.

Parent and teacher rated questionnaire to assess change in symptoms of ODD.

Secondary Outcomes

  • Social Skills Rating System(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)
  • Home Situations Questionnaire(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)
  • Strength and difficulties questionnaire(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)
  • Parent Stress Index(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)
  • Pediatric Quality of Life Index(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)

Study Sites (1)

Loading locations...

Similar Trials