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Recruiting NCT06194994

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

No phase Interventional Oppositional Defiant Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parent Management Training, Tuning Your Temper.
Who it may be relevant to
Registry conditions: Oppositional Defiant Disorder. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iceland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Disruptive Behaviour Rating Scale [Time frame: 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) [Time frame: Pre-treatment; 6-month follow-up; 18-month follow-up.]
Secondary outcome measures (5)
  • Strength and difficulties questionnaire [Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]
  • Home Situations Questionnaire [Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]
  • Social Skills Rating System [Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]
  • Parent Stress Index [Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]
  • Pediatric Quality of Life Index [Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • IQ below 70 (full scale score)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Iceland · 1 center
  • University of Iceland — Reykjavik

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. PMID 35133557
  • Barkley, R. A. (2013). Defiant children: A clinician's manual for assessment and parent training: Guilford press

Identifiers

NCT: NCT06194994 · UI-2023-ODDEMREG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗