Children With ADHD and Emotional Dysregulation (MOODY)

Emotional Dysregulation in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Studies have shown that children with Attention Deficit Hyperactivity Disorder (ADHD) and emotional dysregulation are characterized by high severity of ADHD, comorbid behavior disorders and increased risk of chronic difficulties.

New studies have shown promising results by focusing on improving emotional regulation. We lack knowledge about differences in symptom patterns, stability of symptoms over time, comorbid disorders, neurocognitive functions, knowledge and regulation of emotions, psychosocial risk factors and reactions to stress.

Children 6 to 12 years admitted to specialist and diagnosed with ADHD will be recruited. ADHD children with and without emotional dysregulation defined as fullfilling the criteria for the diagnosis Disruptive Mood Dysregulation Disorder (DMDD) with regard to differences in symptom patterns, stability of symptoms over time, comorbid disorders, neurocognitive functions, knowledge and regulation of emotions, psychosocial risk factors and reactions to stress..

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder; Disruptive Mood Dysregulation Disorder
• Intervention / Treatment: Other: Treatment as usual for ADHD

Detailed Description

Children referred to outpatient psychiatric service will be informed about the study and asked to participate. The clinical assessments in the study will be those that are recommended as good clinical practice, so results will be included in the diagnostic work for the patient.

The data security will follow the Norwegian rules and be monitored by REC and the Data Inspectorate of the hospital.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Pål Zeiner, PhD; Phone Number: +4793264023 +4793264023; Email: pzeiner@online.no
• Study Contact Backup: Name: Pål Zeiner; Phone Number: +4793264023 +4793264023; Email: pzeiner@online.no

Study Locations

• Norway
  • Oslo, Norway, 0801
    • Recruiting
    • Nic Waal's Institute
    • Contact: Marit Coldevin, Psychologist; Phone Number: +4741670137; Email: MaritMelnaes.Coldevin@lds.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children referred to outpatient psychiatric service

Description

Inclusion Criteria:

• Referred to outpatient psychiatric service.
• IQ within normal range.
• Child and parents: Good enough understanding of Norwegian language to give valid answers in interviews and tests.

Exclusion Criteria:

• IQ below normal range.
• Child and parents: Not good enough understanding of Norwegian language to give valid answers in interviews and tests.
• Unresolved crisis in the family.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ADHD with and without DMDD; ADHD with DMDD versus ADHD without DMDD. Observational study at referral and after 6 and 12 months.	Other: Treatment as usual for ADHD; Children are given treatment according to diagnostic conclusion and clinical recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention Deficit Hyperactivity Disorder-Rating Scale total score	Symptom score. Measure difference from baseline. Lower score means improvement.	12 months
Disruptive Mood Dysregulation Disorder total symptom questionnaire score	Symptom score. Symptom score. Measure difference from baseline. Lower score means improvement.	12 months
Number of other comorbid disorders in psychiatric interview	DSM-5 diagnoses: Types and number of diagnoses. More diagnoses means more complex disorder.	Baseline
Affect recognition total score	Test from NEPSY II. Comparison With norms. Difference from norm reported.	Baseline
Hair cortisol Level	Cortisol level over time	Baseline

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Lovisenberg Diakonale Hospital
• Investigators: Principal Investigator: Pål Zeiner, PhD, Head of child psychiatric research

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 2017/135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The data are on patients. We need to decide whether or not anonymous data can be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No