Children With ADHD and Emotional Dysregulation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder, Disruptive Mood Dysregulation Disorder

Intervention / Treatment
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* Other: Treatment as usual for ADHD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADHD with and without DMDD<br>ADHD with DMDD versus ADHD without DMDD. Observational study at referral and after 6 and 12 months. | Other: Treatment as usual for ADHD<br>* Children are given treatment according to diagnostic conclusion and clinical recommendations.<br>|

What is the study measuring?
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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 |