Children With ADHD and Emotional Dysregulation

• Conditions: Disruptive Mood Dysregulation Disorder; Attention Deficit Hyperactivity Disorder
• Interventions: Other: Treatment as usual for ADHD

• Registration Number: NCT03944083
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13
• Study Start: 2019-06
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ADHD with and without DMDD	Treatment as usual for ADHD	ADHD with DMDD versus ADHD without DMDD. Observational study at referral and after 6 and 12 months.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nic Waal's Institute; 🇳🇴 Oslo, Norway