ClinicalTrials.gg
Status unknownNCT04324099Updated Mar 2, 2022

Investigating the Specificity of Neural Correlates for Emotion Processing Deficits in Conduct Disorder and Autism Spectrum Disorders

An observational study in Autism-Spectrum Disorder and Conduct Disorder, sponsored by University Hospital, Basel, Switzerland. Status unknown at 1 site in Switzerland. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by University Hospital, Basel, Switzerland · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
120
Ages
10 Years to 18 Years
Sex
All
01

Study summary

This study is

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

Differences in emotion processing and the underlying neural underpinnings of such differences will be assessed by means of functional magnetic resonance imaging (fMRI) without any contrast agent, combined with adapted emotion processing paradigms and eye tracking techniques.

02

Conditions studied

  • Autism-Spectrum Disorder
  • Conduct Disorder

Keywords

  • Callous-Unemotional traits
  • emotion processing deficits
  • dysfunctional cognitive control processes
03

In context

Child Development Disorders, Pervasive

117 studies on the registry are indexed under Child Development Disorders, Pervasive; 15 are open to participants now.

This study's planned enrollment of 120 is close to the median of 125 across 26 observational studies indexed under Child Development Disorders, Pervasive.

Browse Child Development Disorders, Pervasive studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherneuroimaging session (with simultaneously acquired eye-tracking)

    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).

  • OtherQuestionnaire (for children) assessing traumatic experiences (Childhood trauma questionnaire (CTQ))

    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.

  • OtherSocial and Health Assessment (SAHA) questionnaire (for children)

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

  • OtherMassachusetts Youth Screening Instrument (MAYSI-2) (for children)

    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.

  • OtherInterpersonal Reactivity Index (IRI) (for children)

    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

  • OtherYouth Psychopathic Traits Inventory (YPI) (for children)

    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.

  • OtherReactive Proactive Questionnaire (RPQ) (for children)

    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.

  • OtherEmotion Regulation Questionnaire (for children)

    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)

  • OtherBasic Empathy Scale (BES) (for children)

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

  • OtherPubertal Development Scale (PDS) (for children)

    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.

  • OtherAlabama Parenting Questionnaire (APQ) (for parents)

    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)

  • OtherInventory of Callous Unemotional Traits (ICU) (for parents)

    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.

  • OtherChild Behavior Checklist (CBCL) (for parents)

    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.

  • OtherGriffith Empathy Measure (GEM) (for parents)

    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

  • OtherSocial Responsiveness Scale (SRS) (for parents)

    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.

06

What researchers measure

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

    Time frame: fMRI imaging Day 1

Secondary outcomes

  1. Emotion processing task (fMRI)

    Emotion processing task (fMRI): measures of eye gaze collected by eye-tracking

    Time frame: fMRI imaging Day 1

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Study locations

1 of 1 sites recruiting
  • Department of Child and Adolescent Psychiatry, KJPK (UPK)
    Basel, 4002, Switzerland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04324099
Collaborators
Swiss National Science Foundation
Responsible party
Sponsor
First posted
Mar 27, 2020
Start date
Jul 16, 2020
Primary completion
Apr 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Mar 2, 2022

Study contacts

Christina Stadler, Prof. Dr. med
Contact
christina.stadler@upk.ch
+41 61 325 51 11
Christina Stadler, Prof. Dr. med
principal investigator · Department of Child and Adolescent Psychiatry, KJPK (UPK)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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