Children With ADHD and Emotional Dysregulation

Attention Deficit Hyperactivity Disorder Clinical Trial

— MOODY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03944083
• Other study ID #: 2017/135
• Status: Recruiting
• Start date: June 2019
• Est. completion date: August 2021

Study information

• Verified date: May 2019
• Source: Oslo University Hospital
• Contact: Pål Zeiner, PhD
• Phone: +4793264023
• Email: pzeiner[@]online.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Disruptive Mood Dysregulation Disorder
• Hyperkinesis

Intervention

Other:
• Treatment as usual for ADHD
Children are given treatment according to diagnostic conclusion and clinical recommendations.

Locations

Country	Name	City	State
Norway	Nic Waal's Institute	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Lovisenberg Diakonale Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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