The main objective is to determine whether medication-free adolescents with ADHD show impairments in affective and complex social cognition. The secondary objectives are: 1) To determine whether the use of stimulant medication (on and off) affects…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychische stoornissen: aandachtstekortstoornis met hyperactiviteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performance on tasks for social cognition of the ADHD groups is compared to the
healthy control group.
Secondary outcome
The performance on social cognition of patients with ADHD on stimulants is
compared to the performance of ADHD patients without stimulant medication
(medication-free and stimulants off). Furthermore, the following additional
measures will be used to predict the performance on social cognition measures
and daily social functioning: 1) task performance on tests for executive
functions, and 2) scores on a range of questionnaires on social functioning in
daily life.
Background summary
Social cognition refers to the ability to understand the feelings of other
people. It covers basic processes like the perception and recognition of
emotion from faces, gestures and verbal intonation (prosody) as well as more
complex processes such as the ability to understand other peoples* feelings,
thoughts, expectations and beliefs (theory of mind: ToM), empathy and humor.
Whereas deficits in social cognition are extensively reported in many
populations like in autism, schizophrenia, bipolar disorder or after frontal
lobe brain damage, there is surprisingly little literature about social
cognition in patients with attention-deficit/hyperactivity disorder (ADHD),
especially in adolescence and adulthood. However, there are good reasons to
believe that adolescents and adult patients with ADHD have impairments in
social cognition, since observable social impairments are repeatedly reported
in patients with ADHD. While social cognition in adults with ADHD is currently
investigated by our group (METc2010.357, ABR NL34794.042.11), the focus of the
present study lies on the adolescent population. A literature review on the
cognitive effects of pharmacological treatment (stimulants) in patients with
ADHD, leads to the assumption that possible deficits in social cognition will
not be consistently improved by stimulants. Thus, we expect a decreased
performance of adolescent patients with ADHD both with and without medication
on affective and complex social cognition tasks compared to a healthy control
group.
Study objective
The main objective is to determine whether medication-free adolescents with
ADHD show impairments in affective and complex social cognition. The secondary
objectives are: 1) To determine whether the use of stimulant medication (on and
off) affects the performance of adolescents with ADHD on tasks of affective and
complex social cognition; 2) To determine whether the performance on the more
fundamental executive functioning tasks, in particular inhibition and working
memory, predicts social cognitive performance in adolescents with ADHD; 3) To
determine whether the performance on social cognition tasks predicts social
functioning in daily life in adolescents with ADHD.
Study design
One factorial, between-subject, quasi-experimental design with four
cross-sectional groups.
Study burden and risks
The investigator will meet the patient once for assessment and the duration of
assessment is approximately 2.5 to 3 hours. The time for filling out the
questionnaires is estimated to take 15 minutes for the adolescent and 60
minutes for the parents/caretakers. The behavioral assessment will require a
certain amount of concentration from which a patient can recover after short
breaks. Patients will be unaware of their level of performance. The risks of
this study are negligible and the burden can be considered minimal. Patients
will have no direct benefit from the study.
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for the healthy control group:
• Age of 12 to 16 years, inclusive 16.
• Intelligence score of IQ >= 80
• Both adolescent and parents/caretakers are willing to sign informed consent;General inclusion criteria for patients diagnosed with ADHD:
• Age of 12 to 16 years, inclusive 16.
• Diagnosed with ADHD according to DSM-IV-TR: all subtypes are allowed
• Intelligence score of IQ >= 80
• Both adolescent and parents/caretakers are willing to sign informed consent;Extra inclusion criteria for the specific medication groups:
Medication-free:
• No psychopharmaca usage during the past year; no psychopharmaca prescribed by clinician.;On stimulants:
• Regular intake of stimulant medication, as prescribed by the clinician (co-medication with other psychopharmaca is allowed).
• Intake of the regular dose of stimulant medication on the day of the assessment;Off stimulants:
• Regular intake of stimulant medication, as prescribed by the clinician (co-medication with other psychopharmaca is allowed).
• Discontinuation of stimulant medication intake on the day of the assessment
• Willing to delay stimulant medication intake for this study. If not, the participant is excluded.
Exclusion criteria
Healthy controls:
• Attendance of primary school. All participants should have made the transition from primary to secondary school because this is a major life event for adolescents that impacts on various aspects of their lives, including their social life, which is important for the development of social-cognitive functions.
• Psychiatric diagnosis confirmed by clinician
• Signs of clinical psychopathology as assessed with the Child Behavioural Checklist (see section 4.3 Study procedures)
• Signs of clinical ADHD, as assessed with the Conners* Parent Rating Scale (see section 4.3 Study procedures)
• Signs of clinical autistic spectrum disorder (ASD) as screened with the Social Communication Scale (see section 4.3 Study procedures).;ADHD groups:
• The ADHD-diagnosis is not confirmed by the semi-structured Parent Interview Schedule for Child symptoms (PICS-5: Schachar, Ickowicz, Sugarman, 2008) and the Teacher Telephone Interview (TTI) administered by the researchers. If recent scores (<2 years old) are available, these scores are requested from the patient file.
• Attendance of primary school. All participants should have made the transition from primary to secondary school because this is a major life event for adolescents that impacts on various aspects of their lives, including their social life, which is important for the development of social-cognitive functions.
• Clinical diagnosis of ASD. If scores of the Autism Diagnostic Observation Scale (ADOS) and/or Autism Diagnostic Interview (ADI) are available from the patient record, these scores will be leading in the decision for exclusion.
• Signs of clinical ASD, as screened with the Social Communication Scale (see section 4.3 Study procedures). Other comorbid psychiatric disorders than ASD are allowed.
• Any cerebral neurological diseases
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40031.042.12 |