NCT04324099

Brief Summary

This study is

  1. 1.to investigate the differential and shared neural underpinnings of facial emotion processing within Conduct disorder (CD) and Autism-Spectrum disorder (ASD) and
  2. 2.to investigate the interaction between deficits in emotion processing and dysfunctional cognitive control processes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 16, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2.7 years

First QC Date

March 24, 2020

Last Update Submit

February 28, 2022

Conditions

Keywords

Callous-Unemotional traitsemotion processing deficitsdysfunctional cognitive control processes

Outcome Measures

Primary Outcomes (1)

  • difference between groups (children and adolescents with CD, ASD and typically developing adolescents) in neural activity

    difference between groups in neural activity as measured by Blood Oxygen Level Dependent (BOLD) signal during emotion processing using a priori defined regions of interest (ROIs) including the insula, amygdala, and ventromedial prefrontal Cortex in fMRI

    fMRI imaging Day 1

Secondary Outcomes (1)

  • Emotion processing task (fMRI)

    fMRI imaging Day 1

Study Arms (3)

Conduct disorder

children and adolescents with CD

Other: neuroimaging session (with simultaneously acquired eye-tracking)Other: Questionnaire (for children) assessing traumatic experiences (Childhood trauma questionnaire (CTQ))Other: Social and Health Assessment (SAHA) questionnaire (for children)Other: Massachusetts Youth Screening Instrument (MAYSI-2) (for children)Other: Interpersonal Reactivity Index (IRI) (for children)Other: Youth Psychopathic Traits Inventory (YPI) (for children)Other: Reactive Proactive Questionnaire (RPQ) (for children)Other: Emotion Regulation Questionnaire (for children)Other: Basic Empathy Scale (BES) (for children)Other: Pubertal Development Scale (PDS) (for children)Other: Alabama Parenting Questionnaire (APQ) (for parents)Other: Inventory of Callous Unemotional Traits (ICU) (for parents)Other: Child Behavior Checklist (CBCL) (for parents)Other: Griffith Empathy Measure (GEM) (for parents)Other: Social Responsiveness Scale (SRS) (for parents)

Autism-Spectrum disorder

children and adolescents with ASD

Other: neuroimaging session (with simultaneously acquired eye-tracking)Other: Questionnaire (for children) assessing traumatic experiences (Childhood trauma questionnaire (CTQ))Other: Social and Health Assessment (SAHA) questionnaire (for children)Other: Massachusetts Youth Screening Instrument (MAYSI-2) (for children)Other: Interpersonal Reactivity Index (IRI) (for children)Other: Youth Psychopathic Traits Inventory (YPI) (for children)Other: Reactive Proactive Questionnaire (RPQ) (for children)Other: Emotion Regulation Questionnaire (for children)Other: Basic Empathy Scale (BES) (for children)Other: Pubertal Development Scale (PDS) (for children)Other: Alabama Parenting Questionnaire (APQ) (for parents)Other: Inventory of Callous Unemotional Traits (ICU) (for parents)Other: Child Behavior Checklist (CBCL) (for parents)Other: Griffith Empathy Measure (GEM) (for parents)Other: Social Responsiveness Scale (SRS) (for parents)

typically developing adolescents

typically developing adolescents

Other: neuroimaging session (with simultaneously acquired eye-tracking)Other: Questionnaire (for children) assessing traumatic experiences (Childhood trauma questionnaire (CTQ))Other: Social and Health Assessment (SAHA) questionnaire (for children)Other: Massachusetts Youth Screening Instrument (MAYSI-2) (for children)Other: Interpersonal Reactivity Index (IRI) (for children)Other: Youth Psychopathic Traits Inventory (YPI) (for children)Other: Reactive Proactive Questionnaire (RPQ) (for children)Other: Emotion Regulation Questionnaire (for children)Other: Basic Empathy Scale (BES) (for children)Other: Pubertal Development Scale (PDS) (for children)Other: Alabama Parenting Questionnaire (APQ) (for parents)Other: Inventory of Callous Unemotional Traits (ICU) (for parents)Other: Child Behavior Checklist (CBCL) (for parents)Other: Griffith Empathy Measure (GEM) (for parents)Other: Social Responsiveness Scale (SRS) (for parents)

Interventions

neuroimaging session, including two functional neuroimaging paradigms (ca. 15-20 minutes each) and a short structural image acquisition (mprage) for coregistration. Functional Magnetic Brain Imaging (fMRI) and simultaneous eye-tracking data will be collected during the paradigms: 1) an emotion processing paradigm (adapted from Passamonti et al., 2010); and 2) an emotional Go/noGo paradigm (adapted from Hare et al., 2008).

Autism-Spectrum disorderConduct disordertypically developing adolescents

The Childhood Trauma Questionnaire is a brief survey of six early traumatic experiences (death, divorce, violence, sexual abuse, illness or other), and assesses individual's understanding of their childhood trauma.

Autism-Spectrum disorderConduct disordertypically developing adolescents

Self reported survey assessing social and mental health with four aspects of parenting determined (parental involvement, parental warmth, parental control, and inconsistency of parenting).

Autism-Spectrum disorderConduct disordertypically developing adolescents

The Massachusetts Youth Screening Instrument (MAYSI-2) is a screening instrument developed for detecting mental health needs in youth aged 12-17. Designed as a low-cost, easily administered tool, it screens for multiple issues and can be administered in 10-15 minutes. It is divided into seven scales composed of 52 questions that are designed to detect alcohol/drug use, angryirritable behavior, depression-anxiety, somatic complaints, suicide ideation, thought disturbance, and traumatic experience. Youths answer YES or NO concerning whether each item has been true for them "within the past few months.

Autism-Spectrum disorderConduct disordertypically developing adolescents

The Interpersonal Reactivity Index is a measure of dispositional empathy that takes as its starting point the notion that empathy consists of a set of separate but related constructs. The instrument contains four seven-item subscales (seven Likert items each), each tapping a separate facet of empathy (Empathic Concern, Perspective Taking, Personal Distress, and Fantasy). The 28-item IRI contains four subscales

Autism-Spectrum disorderConduct disordertypically developing adolescents

self-report screening measures to assess psychopathic traits in youth assessing 10 core personality traits associated with the construct (grandiosity, lying, manipulation, callousness, unemotionality, impulsivity, irresponsibility, dishonest charm, remorselessness, and thrill seeking). Each item is scored on an ordinal 4-point Likert scale (1 = Does not apply at all, to 4 = Applies very well). Higher scores reflect an increased presence of psychopathic traits.

Autism-Spectrum disorderConduct disordertypically developing adolescents

The Reactive-Proactive Questionnaire (RPQ) scores (0 (never), 1 sometimes, 2 (often)) for proactive aggression items and reactive items. Proactive and reactive scale scores are summated to obtain total aggression scores.

Autism-Spectrum disorderConduct disordertypically developing adolescents

10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree)

Autism-Spectrum disorderConduct disordertypically developing adolescents

The Basic Empathy Scale (BES) measures 20 items (affective and cognitive empathy) on a Five-point Likert-type scale.

Autism-Spectrum disorderConduct disordertypically developing adolescents

self-report measure of physical development which has been shown to be correlated with measures of pubertal development derived from physical examination. Responses are coded on 4-point scales (1 = no development and 4 = completed development). For girls, a yes-no question about onset of menarche is weighted more heavily (1 = no and 4 = yes). For both genders, ratings are then averaged to create an overall score for physical maturation.

Autism-Spectrum disorderConduct disordertypically developing adolescents

The APQ measures five dimensions of parenting that are relevant to the etiology and treatment of child externalizing problems: (1) positive involvement with children, (2) supervision and monitoring, (3) use of positive discipline techniques, (4) consistency in the use of such discipline and (5) use of corporal punishment (42 self-reported responses, rated on a 5-point Likert scale- 1 (never) to 5 (always) for both child and parent forms)

Autism-Spectrum disorderConduct disordertypically developing adolescents

24-item questionnaire designed to provide a comprehensive assessment of callous and unemotional traits.The ICU has three subscales: Callousness, Uncaring, and Unemotional. The ICU is made up of statements with a 4-point Likert scale, ranging from 0 (Not at all true) to 3 (Definitely True), with higher scores indicating greater CU traits.

Autism-Spectrum disorderConduct disordertypically developing adolescents

The eight empirically-based syndrome scales are: 1. Aggressive Behavior 2. Anxious/Depressed 3. Attention Problems 4. Rule-Breaking Behavior 5. Somatic Complaints 6. Social Problems 7. Thought Problems 8. Withdrawn/Depressed. Higher scores indicate greater Problems.

Autism-Spectrum disorderConduct disordertypically developing adolescents

self-report 23-item measure of empathy in which the respondent answers each item on a nine-point Likert scale from strongly disagree to strongly agree

Autism-Spectrum disorderConduct disordertypically developing adolescents

Social Responsiveness Scale (SRS) measures social ability of children from 4 years to 18 years old. It is used primarily with individuals with Autism Spectrum Disorder (ASD), family members of individuals with ASD, and others who have social impairments. Parent or teacher questionnaire (65 items on a 4-point Likert scale). High scores are associated with more severe social impairments.

Autism-Spectrum disorderConduct disordertypically developing adolescents

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

German speaking children and adolescents (10-18 years of age) attended at the Kinder- und Jugendpsychiatrischen Klinik Basel (KJPK) and with a confirmed diagnosis of CD or ASD. Typically developing children will be recruited using leaflets (will be distributed in the KJPK clinics and in socioeconomically diversesecondary schools within the Canton of Basel-Stadt).

You may qualify if:

  • For all participants: age between 10 and 18 years and an intelligence quotient score of 70 or higher.
  • For patient groups: confirmed clinical diagnoses according to Diagnostic and Statistical Manual (DSM)-5 of CD or ASD (depending on the group), without comorbid depression or anxiety psychological disorders.

You may not qualify if:

  • For all participants: low intelligence (IQ\<70, as they might otherwise not fully understand what they are expected to do inside the scanner), insufficient German language skills or any contraindications for MRI (e.g. pregnancy, any non-removable metal within the subjects' body, claustrophobia).
  • For patient groups: severe developmental disorders, comorbid depressive and/or anxiety disorders will also be excluded from the study since it was shown that these patients might have problems in attention allocation under emotional stimulation.
  • For typically developing participants: suspicion of an undiagnosed clinical disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Child and Adolescent Psychiatry, KJPK (UPK)

Basel, 4002, Switzerland

RECRUITING

MeSH Terms

Conditions

Child Development Disorders, PervasiveConduct Disorder

Interventions

Surveys and QuestionnairesChildhood Trauma QuestionnaireVorinostatBESIntensive Care UnitsSpermine Synthase

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic AcidsHospital UnitsHealth FacilitiesHealth Care Facilities Workforce and ServicesAlkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Christina Stadler, Prof. Dr. med

    Department of Child and Adolescent Psychiatry, KJPK (UPK)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Stadler, Prof. Dr. med

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

July 16, 2020

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations