Clinical trial NCT05049356: Symptoms and Mechanisms of Child Psychiatric Disorders
Official title: Associated Symptoms, Underlying Mechanisms and Parental Factors of Child Psychiatric Disorders With Focus on Severe Irritability.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disruptive Mood Dysregulation Disorder
Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
Severe Irritability
Child Psychiatric Disorders
Keywords: Neuropsychology
Neurocognition
Executive function
Social cognition
Mentalization
Affect recognition
Stress
Cortisol
Parental Stress
Attachment
Behavior symptoms
Emotion symptoms
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: Lovisenberg Diakonale Hospital
First posted: 2021-09-20
Enrollment: 218
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Parents of children referred to outpatient psychiatric service (The Department of Child and Adolescent Psychiatry at Oslo University Hospital, and Nic Waals Institute at Lovisenberg Hospital) will be informed about the study and asked to participate.

Brief summary: In this study the investigators will examine psychiatric symptoms, central neurocognitive functions, parental stress and attachment styles, and biological factors that can give new knowledge about some of the mechanisms present in children referred to outpatient psychiatric clinics. A specific focus will be given to children suffering from severe irritability.

Detailed description: In this study the investigators will examine psychiatric symptoms, central neurocognitive functions, parental stress and attachment styles, and biological factors that can give new knowledge about some of the mechanisms present in children referred to outpatient psychiatric service. A specific focus will be given to children suffering from severe irritability making problems at home, in school, and/or with peers.

Disruptive Mood Dysregulation Disorder (DMDD) is characterized by chronic and severe irritability and anger in children. DMDD understood as severe or clinical irritability can be regarded as laying above a certain threshold on a irritability continuum. Due to DMDD being a relatively new and debated diagnosis there is an urgent need to gain better understanding of the underlying mechanisms of severe irritability in children.

This study will explore emotion and behavior symptoms, neuropsychological functions (including social perception), perceived parental stress and attachment styles, and cortisol levels of children and their mothers, in children referred to outpatient psychiatric service including children with severe irritability. Parents of children 6 to 12 years will be informed and asked to participate.

The work on severe irritability will be divided into six main areas:

1. Severe irritability in a Norwegian clinical population: prevalence, comorbidity and associated difficulties
2. Social and emotional understanding in severe irritability in children
3. Executive function in severe irritability in children
4. Stress response in severe irritability in children
5. Parental stress and attachment style in parents of severe irritability in children
6. DMDD: An affective or conduct disorder? Comparing anxiety and depressive symptoms

Eligibility criteria: Inclusion Criteria:

* Referred to outpatient psychiatric service
* Intelligence quotient (IQ) within normal range
* Child and parents: Good enough understanding of Norwegian language to give valid answers in interview and tests.
* Clarified care situation

Exclusion Criteria:

* IQ below normal range
* Child and parents: Not good enough understanding of Norwegian language to give valid answers in interview and tests
* Unclarified care situation

Primary outcomes:
measure: Social Perception by task performance: Affect Recognition
timeFrame: Baseline
measure: Social Perception by task performance: Theory of Mind
timeFrame: Baseline
measure: Executive function by task performance: Verbal Working Memory
timeFrame: Baseline
measure: Executive function by task performance: Inhibitory Control
timeFrame: Baseline
measure: Executive function by task performance: Cognitive Flexibility
timeFrame: Baseline
measure: Executive function by task performance: non-verbal Cognitive Flexibility
timeFrame: Baseline
measure: Executive function by report: Inhibitory control
timeFrame: Baseline
measure: Executive function by report: Cognitive flexibility
timeFrame: Baseline
measure: Executive function by report: Emotional Control
timeFrame: Baseline
measure: Executive function by report: Initiate
timeFrame: Baseline
measure: Executive function by report: Working Memory
timeFrame: Baseline
measure: Executive function by report: Plan/Organize
timeFrame: Baseline
measure: Executive function by report: Organization of Materials
timeFrame: Baseline
measure: Executive function by report: Task-Monitor
timeFrame: Baseline
measure: Executive function by report: Self-Monitor
timeFrame: Baseline
measure: Overall executive function by report
timeFrame: Baseline
measure: Executive function by report: Behavior Regulation
timeFrame: Baseline
measure: Executive function by report: Emotion Regulation
timeFrame: Baseline
measure: Executive function by report: Cognitive Regulation
timeFrame: Baseline
measure: Perceived Parenting Stress by report
timeFrame: Baseline
measure: Stress Response by Cortisol levels
timeFrame: Baseline
measure: Attachment style in parents by report
timeFrame: Baseline
measure: Withdrawn and Depressed Symptoms by report
timeFrame: Baseline
measure: Anxious and Depressed Symptoms by report
timeFrame: Baseline
measure: Somatic Complaints by report
timeFrame: Baseline
measure: Social Problems by report
timeFrame: Baseline
measure: Thought Problems by report
timeFrame: Baseline
measure: Attention Problems by report
timeFrame: Baseline
measure: Rule-Breaking Behavior by report
timeFrame: Baseline
measure: Aggressive Behavior by report
timeFrame: Baseline
measure: Internalizing problems by report
timeFrame: Baseline
measure: Externalizing problems by report
timeFrame: Baseline
measure: Total behavior and emotional problems by report
timeFrame: Baseline
measure: Affective Symptoms by report
timeFrame: Baseline
measure: Anxiety Symptoms by report
timeFrame: Baseline
measure: Somatic Problems by report
timeFrame: Baseline
measure: Attention Deficit/Hyperactivity Symptoms by report
timeFrame: Baseline
measure: Oppositional Defiant Symptoms by report
timeFrame: Baseline
measure: Conduct Problems by report
timeFrame: Baseline
measure: Irritability by report
timeFrame: Baseline
measure: Dysregulation by report
timeFrame: Baseline
measure: Global Functioning
timeFrame: Baseline
measure: Follow-up (6 months): Disruptive Mood Dysregulation Disorder
timeFrame: Follow-up at 6 months
measure: Follow-up (12 months): Diagnosis
timeFrame: Follow-up at 12 months
measure: Follow-up (12 months): Symptoms
timeFrame: Follow-up at 12 months
measure: Affective Interpretation Bias
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Child and Adolescent Psychiatry, Oslo University Hospital
city: Oslo
country: Norway
facility: Nic Waals Institute, Lovisenberg Hospital
Study officials:
affiliation: Head of Child Psychiatric Research at Oslo University Hospital
name: Pål Zeiner, PhD
role: STUDY_DIRECTOR
References: