Children With ADHD and Emotional Dysregulation

NCT ID: NCT03944083

Last Updated: 2019-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-30

Study Completion Date

2021-08-31

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.

Conditions

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Attention Deficit Hyperactivity Disorder Disruptive Mood Dysregulation Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ADHD with and without DMDD

ADHD with DMDD versus ADHD without DMDD. Observational study at referral and after 6 and 12 months.

Treatment as usual for ADHD

Intervention Type OTHER

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

Interventions

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Treatment as usual for ADHD

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

Intervention Type OTHER

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lovisenberg Diakonale Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pål Zeiner

Project manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pål Zeiner, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of child psychiatric research

Locations

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Nic Waal's Institute

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Pål Zeiner, PhD

Role: CONTACT

+4793264023 ext. +4793264023

Pål Zeiner

Role: CONTACT

+4793264023 ext. +4793264023

Facility Contacts

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Marit Coldevin, Psychologist

Role: primary

+4741670137

Other Identifiers

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2017/135

Identifier Type: -

Identifier Source: org_study_id

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