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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Iceland

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosed with Oppositional Defiant Disorder

Icelandic speaking (child and parent/guardian)

Disqualifiers

IQ below 70 (full scale score)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

196 Participants
are divided into 2 treatment groups
Group A: Parent TrainingExperimental treatment 1 intervention
Group B: Child directed treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disruptive Behaviour Rating Scale

Parent and teacher rated questionnaire to assess change in symptoms of ODD.

Time frame
Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
2

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.

Time frame
Pre-treatment; 6-month follow-up; 18-month follow-up.

Secondary outcomes

1

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.

Time frame
Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
2

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.

Time frame
Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
3

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.

Time frame
Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
4

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.

Time frame
Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.

Other outcomes

Sponsors and contacts

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University of Iceland

Lead sponsor

Stockholm University

Collaborator