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

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 10 to 18 years
• All sexes
• Healthy volunteers accepted
• Child, Adult

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).

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Autism-Spectrum Disorder, Conduct Disorder

Being tested

neuroimaging session (with simultaneously acquired eye-tracking), Questionnaire (for children) assessing traumatic experiences (Childhood trauma questionnaire (CTQ)), Social and Health Assessment (SAHA) questionnaire (for children), Massachusetts Youth Screening Instrument (MAYSI-2) (for children), Interpersonal Reactivity Index (IRI) (for children)

Keywords

Callous-Unemotional traits, emotion processing deficits, dysfunctional cognitive control processes

Medical subject headings

Child Development Disorders, Pervasive, Conduct Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• neuroimaging session (with simultaneously acquired eye-tracking)Other

  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).

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

  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.

• Social and Health Assessment (SAHA) questionnaire (for children)Other

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

• Massachusetts Youth Screening Instrument (MAYSI-2) (for children)Other

  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.

• Interpersonal Reactivity Index (IRI) (for children)Other

  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

• Youth Psychopathic Traits Inventory (YPI) (for children)Other

  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.

• Reactive Proactive Questionnaire (RPQ) (for children)Other

  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.

• Emotion Regulation Questionnaire (for children)Other

  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)

• Basic Empathy Scale (BES) (for children)Other

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

• Pubertal Development Scale (PDS) (for children)Other

  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.

• Alabama Parenting Questionnaire (APQ) (for parents)Other

  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)

• Inventory of Callous Unemotional Traits (ICU) (for parents)Other

  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.

• Child Behavior Checklist (CBCL) (for parents)Other

  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.

• Griffith Empathy Measure (GEM) (for parents)Other

  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

• Social Responsiveness Scale (SRS) (for parents)Other

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   Measured: fMRI imaging Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted27 Mar 2020
2. Study start16 Jul 2020
3. Primary completionApr 2023 (estimated)
4. Study completionJun 2023 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Autism-Spectrum DisorderStudies of the same condition, open and under way.
• More trials run by University Hospital, Basel, SwitzerlandThe 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.