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

NCT06194994 | Recruiting DMC

• 1 other identifier: UI-2023-ODDEMREG
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Oppositional Defiant Disorder

Keywords

Oppositional Defiant Disorder; Emotion Regulation; Child Psychopathology

Outcome Measures

Primary Outcomes (2)

• Disruptive Behaviour Rating Scale

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

  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)

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

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

Secondary Outcomes (5)

• Strength and difficulties questionnaire

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

• Home Situations Questionnaire

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

• Social Skills Rating System

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

• Parent Stress Index

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

• Pediatric Quality of Life Index

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

Study Arms (2)

Parent Training

EXPERIMENTAL

Behavioral parent training intervention. Individual sessions.

Behavioral: Parent Management Training

Child directed treatment

EXPERIMENTAL

Child directed cognitive behavioral therapy. Individual sessions.

Behavioral: Tuning Your Temper

Interventions

Parent Management Training BEHAVIORAL

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

Parent Training

Tuning Your Temper BEHAVIORAL

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

Child directed treatment

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• IQ below 70 (full scale score)

Sponsors & Collaborators

• University of Iceland: lead
• Stockholm University: collaborator

Study Sites (1)

University of Iceland

Reykjavik, 101, Iceland

RECRUITING

Related Publications (2)

• 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 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Oppositional Defiant Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Urdur Njardvik, PhD

  Department of Psychology, University of Iceland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urdur Njardvik, PhD

CONTACT

+354-525-5957; urdurn@hi.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers and outcomes assessors will be blind to emotion regulation status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomisation to two different treatments which will be compared.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: January 8, 2024
• Study Start: January 4, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)