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

Not Applicable

Recruiting

• Conditions: Oppositional Defiant Disorder
• Interventions: Behavioral: Tuning Your Temper; Behavioral: Parent Management Training

• Registration Number: NCT06194994
• Lead Sponsor: University of Iceland

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.

Study Timeline

• Study First Submitted: 2023-06-22
• Status Verified: 2024-01
• Study Start: 2024-01-04
• Study First Submitted QC: 2024-01-05
• Last Update Submitted: 2024-01-05
• Study First Posted: 2024-01-08
• Last Update Posted: 2024-01-08
• Primary Completion: 2027-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

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

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Exclusion Criteria

• IQ below 70 (full scale score)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Child directed treatment	Tuning Your Temper	Child directed cognitive behavioral therapy. Individual sessions.
Parent Training	Parent Management Training	Behavioral parent training intervention. Individual sessions.

Primary Outcome Measures

Name	Time	Method
Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)	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	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 Outcome Measures

Name	Time	Method
Social Skills Rating System	Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.	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.
Home Situations Questionnaire	Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.	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.
Strength and difficulties questionnaire	Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.	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.
Parent Stress Index	Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.	Parent rated questionnaire to assess change in parental stress. Scores range from 18-90 with higher scores indicating higher levels of parental stress.
Pediatric Quality of Life Index	Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.	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.

Trial Locations

Locations (1)

University of Iceland; 🇮🇸 Reykjavik, Iceland