Skip to main content
Clinical Trials/NCT03944083
NCT03944083
Unknown
Not Applicable

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

Oslo University Hospital1 site in 1 country200 target enrollmentJune 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Oslo University Hospital
Enrollment
200
Locations
1
Primary Endpoint
Attention Deficit Hyperactivity Disorder-Rating Scale total score
Last Updated
6 years ago

Overview

Brief Summary

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..

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.

Registry
clinicaltrials.gov
Start Date
June 2019
End Date
August 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Pål Zeiner

Project manager

Oslo University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Attention Deficit Hyperactivity Disorder-Rating Scale total score

Time Frame: 12 months

Symptom score. Measure difference from baseline. Lower score means improvement.

Affect recognition total score

Time Frame: Baseline

Test from NEPSY II. Comparison With norms. Difference from norm reported.

Hair cortisol Level

Time Frame: Baseline

Cortisol level over time

Disruptive Mood Dysregulation Disorder total symptom questionnaire score

Time Frame: 12 months

Symptom score. Symptom score. Measure difference from baseline. Lower score means improvement.

Number of other comorbid disorders in psychiatric interview

Time Frame: Baseline

DSM-5 diagnoses: Types and number of diagnoses. More diagnoses means more complex disorder.

Study Sites (1)

Loading locations...

Similar Trials