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Children With ADHD and Emotional Dysregulation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03944083
Acronym
MOODY
Enrollment
200
Registered
2019-05-09
Start date
2019-06-30
Completion date
2021-08-31
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder, Disruptive Mood Dysregulation Disorder

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.

Interventions

Children are given treatment according to diagnostic conclusion and clinical recommendations.

Sponsors

Lovisenberg Diakonale Hospital
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Attention Deficit Hyperactivity Disorder-Rating Scale total score12 monthsSymptom score. Measure difference from baseline. Lower score means improvement.
Disruptive Mood Dysregulation Disorder total symptom questionnaire score12 monthsSymptom score. Symptom score. Measure difference from baseline. Lower score means improvement.
Number of other comorbid disorders in psychiatric interviewBaselineDSM-5 diagnoses: Types and number of diagnoses. More diagnoses means more complex disorder.
Affect recognition total scoreBaselineTest from NEPSY II. Comparison With norms. Difference from norm reported.
Hair cortisol LevelBaselineCortisol level over time

Countries

Norway

Contacts

Primary ContactPål Zeiner, PhD
pzeiner@online.no+4793264023
Backup ContactPål Zeiner
pzeiner@online.no+4793264023

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026