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NCT Number: NCT06194994

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

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.

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Key information

Conditions

Oppositional Defiant Disorder Attention Deficit and Disruptive Behavior Disorders Behavior Emotional Regulation Mental Disorders Neurodevelopmental Disorders Self-Control Social Behavior

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iceland

Reykjavik, 101, Iceland

Location status: Recruiting

Location contact

Urdur Njardvik, PhD

CONTACT

[email protected]

+3545255957

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • IQ below 70 (full scale score)

Treatment and study plan

Parent Management Training

Behavioral

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

Tuning Your Temper

Behavioral

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

Primary outcomes

  1. Disruptive Behaviour Rating Scale

    Time frame: 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.

  2. 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.

    Diagnostic Interview to assess whether a child changes in diagnostic status, whether child meets DSM-5 diagnostic criteria for mental disorders.

Secondary outcomes

  1. Strength and difficulties questionnaire

    Time frame: 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.

  2. Home Situations Questionnaire

    Time frame: 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.

  3. Social Skills Rating System

    Time frame: 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.

  4. Parent Stress Index

    Time frame: 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.

  5. Pediatric Quality of Life Index

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Urdur Njardvik, PhD

CONTACT

[email protected]

+354-525-5957

Sponsors and collaborators

Lead sponsor

University of Iceland

Other

Collaborators

  • Stockholm University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jan 8, 2024
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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