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

NCT ID: NCT06194994

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-04
• Study Completion Date: 2029-12-31

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.

Conditions

Oppositional Defiant Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Parent Training

Behavioral parent training intervention. Individual sessions.

Group Type: EXPERIMENTAL

Parent Management Training

Intervention Type: BEHAVIORAL

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

Child directed treatment

Child directed cognitive behavioral therapy. Individual sessions.

Group Type: EXPERIMENTAL

Tuning Your Temper

Intervention Type: BEHAVIORAL

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

Interventions

Parent Management Training

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

Intervention Type: BEHAVIORAL

Tuning Your Temper

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• IQ below 70 (full scale score)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stockholm University

OTHER

Sponsor Role: collaborator

University of Iceland

OTHER

Sponsor Role: lead

Responsible Party

Urdur Njardvik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Urdur Njardvik, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, University of Iceland

Locations

University of Iceland

Reykjavik, , Iceland

Site Status: RECRUITING

Countries

Iceland

Central Contacts

Urdur Njardvik, PhD

Role: CONTACT

urdurn@hi.is

+354-525-5957

Facility Contacts

Urdur Njardvik, PhD

Role: primary

urdurn@hi.is

+3545255957

References

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.

Reference Type: BACKGROUND

PMID: 35133557 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

UI-2023-ODDEMREG

Identifier Type: -

Identifier Source: org_study_id