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

Oppositional Defiant Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194994
• Other study ID #: UI-2023-ODDEMREG
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2024
• Est. completion date: December 2029

Study information

• Verified date: January 2024
• Source: University of Iceland
• Contact: Urdur Njardvik, PhD
• Phone: +354-525-5957
• Email: urdurn[@]hi.is
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 2029
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• IQ below 70 (full scale score)

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Oppositional Defiant Disorder

Intervention

Behavioral:
• Parent Management Training
Behavioral parent training program aimed at increasing compliance and positive behaviours while decreasing disruptive behaviours
• Tuning Your Temper
Cognitive behavioural treatment for children focusing on arousal reduction, problem solving and cognitive restructuring.

Locations

Country	Name	City	State
Iceland	University of Iceland	Reykjavik

Sponsors (2)

Lead Sponsor	Collaborator
University of Iceland	Stockholm University

Country where clinical trial is conducted

Iceland, 

References & Publications (2)

Barkley, R. A. (2013). Defiant children: A clinician's manual for assessment and parent training: Guilford press

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.