Children With ADHD and Emotional Dysregulation

NCT03944083 | Unknown

• 1 other identifier: 2017/135
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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..

Conditions

Attention Deficit Hyperactivity Disorder; Disruptive Mood Dysregulation Disorder

Outcome Measures

Primary Outcomes (5)

• Attention Deficit Hyperactivity Disorder-Rating Scale total score

  Symptom score. Measure difference from baseline. Lower score means improvement.

  12 months

• Disruptive Mood Dysregulation Disorder total symptom questionnaire score

  Symptom score. Symptom score. Measure difference from baseline. Lower score means improvement.

  12 months

• Number of other comorbid disorders in psychiatric interview

  DSM-5 diagnoses: Types and number of diagnoses. More diagnoses means more complex disorder.

  Baseline

• Affect recognition total score

  Test from NEPSY II. Comparison With norms. Difference from norm reported.

  Baseline

• Hair cortisol Level

  Cortisol level over time

  Baseline

Study Arms (1)

ADHD with and without DMDD

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

Other: Treatment as usual for ADHD

Interventions

Treatment as usual for ADHD OTHER

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

ADHD with and without DMDD

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children referred to outpatient psychiatric service

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Lovisenberg Diakonale Hospital: collaborator

Study Sites (1)

Nic Waal's Institute

Oslo, 0801, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hair samples analyzed on cortisol.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Pål Zeiner, PhD

  Head of child psychiatric research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pål Zeiner, PhD

CONTACT

+4793264023; pzeiner@online.no

Pål Zeiner

CONTACT

+4793264023; pzeiner@online.no

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 9, 2019
• Study Start: June 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

NO (1)