Emotion Regulation as a Moderator of Two Different Treatments for Children With ODD

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

Study Overview

• Status: Recruiting
• Conditions: Oppositional Defiant Disorder
• Intervention / Treatment: Behavioral: Parent Management Training; Behavioral: Tuning Your Temper

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.

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Urdur Njardvik, PhD; Phone Number: +354-525-5957; Email: urdurn@hi.is

Study Locations

• Iceland
  • Reykjavik, Iceland, 101
    • Recruiting
    • University of Iceland
    • Contact: Urdur Njardvik, PhD; Phone Number: +3545255957; Email: urdurn@hi.is

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• IQ below 70 (full scale score)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parent Training; Behavioral parent training intervention. Individual sessions.	Behavioral: Parent Management Training; Behavioral parent training program aimed at increasing compliance and positive behaviours while decreasing disruptive behaviours
Experimental: Child directed treatment; Child directed cognitive behavioral therapy. Individual sessions.	Behavioral: Tuning Your Temper; Cognitive behavioural treatment for children focusing on arousal reduction, problem solving and cognitive restructuring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disruptive Behaviour Rating Scale	Parent and teacher rated questionnaire to assess change in symptoms of ODD.	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.	Pre-treatment; 6-month follow-up; 18-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.

Collaborators and Investigators

• Sponsor: University of Iceland
• Collaborators: Stockholm University
• Investigators: Principal Investigator: Urdur Njardvik, PhD, Department of Psychology, University of Iceland

Publications and helpful links

General Publications

• Njardvik U, Smaradottir H, Ost LG. The Effects of Emotion Regulation Treatment on Disruptive Behavior Problems in Children: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2022 Jul;50(7):895-905. doi: 10.1007/s10802-022-00903-7. Epub 2022 Feb 8.
• Barkley, R. A. (2013). Defiant children: A clinician's manual for assessment and parent training: Guilford press

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Emotion Regulation; Oppositional Defiant Disorder; Child Psychopathology
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders
• Other Study ID Numbers: UI-2023-ODDEMREG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No