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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06194994
Enrollment
196
Registered
2024-01-08
Start date
2024-01-04
Completion date
2029-12-31
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oppositional Defiant Disorder

Keywords

Oppositional Defiant Disorder, Emotion Regulation, Child Psychopathology

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.

Interventions

Behavioral parent training program aimed at increasing compliance and positive behaviours while decreasing disruptive behaviours

BEHAVIORALTuning Your Temper

Cognitive behavioural treatment for children focusing on arousal reduction, problem solving and cognitive restructuring.

Sponsors

Stockholm University
CollaboratorOTHER
University of Iceland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Participants, care providers and outcomes assessors will be blind to emotion regulation status.

Intervention model description

Randomisation to two different treatments which will be compared.

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* IQ below 70 (full scale score)

Design outcomes

Primary

MeasureTime frameDescription
Disruptive Behaviour Rating ScalePre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.Parent and teacher rated questionnaire to assess change in symptoms of ODD.
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.

Secondary

MeasureTime frameDescription
Social Skills Rating SystemPre-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.
Strength and difficulties questionnairePre-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.
Pediatric Quality of Life IndexPre-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.
Parent Stress IndexPre-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.
Home Situations QuestionnairePre-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.

Countries

Iceland

Contacts

Primary ContactUrdur Njardvik, PhD
urdurn@hi.is+354-525-5957

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026