Attention Deficit Hyperactivity DisorderMOODYNCT03944083
Children With ADHD and Emotional Dysregulation
An observational study of Attention Deficit Hyperactivity Disorder and Disruptive Mood Dysregulation Disorder, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Disruptive Mood Dysregulation Disorder
- What is being tested?
- Treatment as usual for ADHD
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2019to Aug 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children referred to outpatient psychiatric service
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Nic Waal's Institute
Oslo, 0801
Marit Coldevin, Psychologist, +4741670137, MaritMelnaes.Coldevin@lds.no
About this study
Official title: Emotional Dysregulation in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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..
Read the 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.
- Being tested
- Treatment as usual for ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usual for ADHDOther
Children are given treatment according to diagnostic conclusion and clinical recommendations.
| Study group | Role | What they receive |
|---|---|---|
| ADHD with and without DMDD | ADHD with DMDD versus ADHD without DMDD. Observational study at referral and after 6 and 12 months. Receives: Other: Treatment as usual for ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Deficit Hyperactivity Disorder-Rating Scale total score
Symptom score. Measure difference from baseline. Lower score means improvement.
Measured: 12 months
Disruptive Mood Dysregulation Disorder total symptom questionnaire score
Symptom score. Symptom score. Measure difference from baseline. Lower score means improvement.
Measured: 12 months
Number of other comorbid disorders in psychiatric interview
DSM-5 diagnoses: Types and number of diagnoses. More diagnoses means more complex disorder.
Measured: Baseline
Affect recognition total score
Test from NEPSY II. Comparison With norms. Difference from norm reported.
Measured: Baseline
Hair cortisol Level
Cortisol level over time
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study startJun 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital
- Responsible party
- Principal investigator, Pål Zeiner, Oslo University Hospital
- Investigators
- Pål Zeiner, PhD, Principal investigator, Head of child psychiatric research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944083
- Sponsor's protocol ID
- 2017/135
- Acronym
- MOODY
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data are on patients. We need to decide whether or not anonymous data can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Dysregulation in Children With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT03944083
- Acronym / sponsor ID
- MOODY / 2017/135
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital
- Study start
- Jun 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD with and without DMDD | – | Other: Treatment as usual for ADHDADHD with DMDD versus ADHD without DMDD. Observational study at referral and after 6 and 12 months. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children referred to outpatient psychiatric service
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usual for ADHDChildren are given treatment according to diagnostic conclusion and clinical recommendations. | Other | ADHD with and without DMDD |
Primary outcome
Attention Deficit Hyperactivity Disorder-Rating Scale total score
Time frame: 12 months
Symptom score. Measure difference from baseline. Lower score means improvement.
Disruptive Mood Dysregulation Disorder total symptom questionnaire score
Time frame: 12 months
Symptom score. Symptom score. Measure difference from baseline. Lower score means improvement.
Number of other comorbid disorders in psychiatric interview
Time frame: Baseline
DSM-5 diagnoses: Types and number of diagnoses. More diagnoses means more complex disorder.
Affect recognition total score
Time frame: Baseline
Test from NEPSY II. Comparison With norms. Difference from norm reported.
Hair cortisol Level
Time frame: Baseline
Cortisol level over time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: Undecided. The data are on patients. We need to decide whether or not anonymous data can be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pål Zeiner, PhD principal investigator
Head of child psychiatric research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Disruptive Mood Dysregulation Disorder, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pål Zeiner, PhD (+4793264023 ext. +4793264023, pzeiner@online.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention Deficit Hyperactivity Disorder-Rating Scale total score (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.