Clinical trial NCT06194994: Emotion Regulation as a Moderator of Two Different Treatments for Children With ODD
Official title: Emotion Regulation as a Moderator of Two Different Treatments for Children With Oppositional Defiant Disorder: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oppositional Defiant Disorder
Keywords: Oppositional Defiant Disorder
Emotion Regulation
Child Psychopathology
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: Stockholm University
First posted: 2024-01-08
Enrollment: 196
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomisation to two different treatments which will be compared.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* IQ below 70 (full scale score)

Primary outcomes:
measure: Disruptive Behaviour Rating Scale
timeFrame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
measure: Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
timeFrame: Pre-treatment; 6-month follow-up; 18-month follow-up.
Secondary outcomes:
measure: Strength and difficulties questionnaire
timeFrame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
measure: Home Situations Questionnaire
timeFrame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
measure: Social Skills Rating System
timeFrame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
measure: Parent Stress Index
timeFrame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
measure: Pediatric Quality of Life Index
timeFrame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: University of Iceland
Study officials:
affiliation: Department of Psychology, University of Iceland
name: Urdur Njardvik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Barkley, R. A. (2013). Defiant children: A clinician's manual for assessment and parent training: Guilford press