Clinical trial NCT03944083: Children With ADHD and Emotional Dysregulation
Official title: Emotional Dysregulation in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Hyperactivity Disorder
Disruptive Mood Dysregulation Disorder
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Lovisenberg Diakonale Hospital
First posted: 2019-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children referred to outpatient psychiatric service

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.

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.

Primary outcomes:
measure: Attention Deficit Hyperactivity Disorder-Rating Scale total score
timeFrame: 12 months
measure: Disruptive Mood Dysregulation Disorder total symptom questionnaire score
timeFrame: 12 months
measure: Number of other comorbid disorders in psychiatric interview
timeFrame: Baseline
measure: Affect recognition total score
timeFrame: Baseline
measure: Hair cortisol Level
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Nic Waal's Institute
Study officials:
affiliation: Head of child psychiatric research
name: Pål Zeiner, PhD
role: PRINCIPAL_INVESTIGATOR
References: