- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326543
Temperament Dimensions and Awakening Salivary Cortisol Levels in ADHD.
Association Between Temperament Dimensions and Awakening Salivary Cortisol Levels in Children and Adolescents With Attention Deficit Hyperactivity/Impulsivity Disorder (ADHD)
Study Overview
Status
Conditions
Detailed Description
Recently evidence suggests that measures of child temperament may predict ADHD symptoms (Einziger et al., 2018). Temperament is a characteristic of personality (Buss & Plomin, 1984; Crowell, 2016) and refers to individual, neurobiologically-based difference in reactivity, self-regulation and cognition (Eisenberg, 2012).
It has been previously emphasized (Nigg J., 2016), that Hypotalamic-Pituitary-Adrenal (HPA) axis, through the cortisol hormone, may represent a powerful biological measure of behavioural self-regulatory systems, activity level, cognition, temperament (Stadler et al, 2011; Martel et al., 2009; Sonuga-Barke, 2005) and arousal (Snoek, Van Goozen, Matthys, Buitelaar, & Engeland, 2004). Cortisol is released from the surrenal gland by means of the HPA axis activation, in response to catecholaminergic neurotransmitters (Ulrich-Lai & Herman, 2009). Cortisol is involved in the regulation of a wide range of body functions, including emotion processing (Skosnik, Chatterton, Swisher, & Park, 2000), awakening (Fries, Dettenborn, & Kirschbaum, 2009) and stress responses (Chrousos, Kino, & Charmandari, 2009).
Both cortisol and temperament may share self-response regulatory processes (Martel et al., 2008; Nigg, 2016; Ulrich-Lai & Herman, 2009), and one study on 70 healthy pre-schoolers indicates that children with SE temperament has higher morning salivary cortisol levels during their first week of a new primary school year (Davis, Donzella, Krueger, & Gunnar, 1999), hypothesized as a stress-induced effect.
To date, no studies have been conducted to study heterogeneity starting from the self-response regulatory processes between temperament and cortisol in children and adolescents with ADHD.
As for clinical application of HPA-axis and cortisol level in ADHD diagnosis and dimension, available studies are, as yet, either inconsistent (Bonvicini, Faraone, & Scassellati, 2016; Freitag et al, 2009, Corominas et al, 2012) or suggestive, but not significant, upon dimensional stratification of ADHD symptoms (Pinto et al., 2016).
The aims of this study to contribute to the issue of clinical heterogeneity of ADHD, analysing whether ADHD symptoms and co-morbidity traits simultaneously link to both cortisol level and temperament dimensions, as biomarkers of arousal and inhibited behaviour. To pursue our aim we formulated five specific research questions: i) Do temperament dimensions and awakening cortisol level differ between children and adolescents with ADHD and TDC? ii) Do temperament dimensions and awakening cortisol levels correlate with dimension of ADHD core symptoms? iii) Does awakening cortisol level associate with any of the three-temperament dimension? iv) Do parent ratings of the oppositional and defiant traits and anxiety traits affect the association between temperament dimensions and cortisol levels with ADHD core symptoms in the ADHD group?
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sassari, Italy, 07100
- Alessandra Carta
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Sassari, Italy, 07100
- Complex Operating Unit of Child and Adolescent Neuropsychiatry - University of Sassari
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
ADHD group:
- The assessment was completed as part of their routine psychiatric assessment using unstructured interview, screening of ADHD and other psychiatric symptoms through parent questionnaires, and direct observation with the participants, which led to a DSM-5-based diagnosis of ADHD;
- Signed informed consent from parents or legal guardian and/or assent for youth aged >12 y/o.
TDY (Typically Developing Control) - group:
- Signed informed consent from parents or legal guardian and/or assent for youth aged >12 y/o;
- TDY were recruited from pre-school, primary and secondary schools in the local catchment area.
- Assessment of the TDY was carried out by a clinician in schools through an unstructured interview with the parents and teachers.
Exclusion Criteria:
ADHD group:
- Not signed informed consent from parents or legal guardian and/or assent for youth aged >12 y/o;
- IQ below 70;
- neurological and other psychiatric disorders;
- genetic and/or medical conditions mimicking ADHD symptoms;
- treatment with psychotropic medications other than ADHD medications;
- TDY were also excluded if they presented with any learning or behavioural difficulties as reported in the parent and teacher interviews, as well as mild, moderate or severe symptoms of ADHD in the clinician-led rating scale.
TDY (Typically Developing Control) - group:
- Not signed informed consent from parents or legal guardian and/or assent for youth aged >12 y/o;
- IQ below 70;
- neurological and other psychiatric disorders;
- genetic and/or medical conditions mimicking ADHD symptoms;
- treatment with psychotropic medications other than ADHD medications.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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ADHD and typically developing controls
120 subject: 53 with an ADHD clinical diagnosis and 57 typically developing controls aged between 3 and 16 years old.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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To examine the association of ADHD with temperament dimensions and low cortisol levels, building on previous research that these may represent potential markers of low behaviour inhibition and under-arousal in the disorder.
Time Frame: six months
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Specifically:
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six months
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To evaluate the association between cortisol levels and co-morbidity severity symptoms.
Time Frame: six months
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We test the association of oppositional-defiant and anxiety traits with the temperament dimensions and cortisol levels, and whether the association of ADHD with each temperament or cortisol measure remains when controlling for these comorbid psychiatric traits.
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six months
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Collaborators and Investigators
Investigators
- Principal Investigator: ALESSANDRA CARTA, Sassari University
Publications and helpful links
General Publications
- Karalunas SL, Fair D, Musser ED, Aykes K, Iyer SP, Nigg JT. Subtyping attention-deficit/hyperactivity disorder using temperament dimensions: toward biologically based nosologic criteria. JAMA Psychiatry. 2014 Sep;71(9):1015-24. doi: 10.1001/jamapsychiatry.2014.763.
- Karalunas SL, Fair D, Musser ED, Aykes K, Iyer SP, Nigg JT. Notice of Retraction and Replacement. Karalunas et al. Subtyping attention-deficit/hyperactivity disorder using temperament dimensions: toward biologically based nosologic criteria. JAMA Psychiatry. 2014;71(9):1015-1024. JAMA Psychiatry. 2018 Apr 1;75(4):408-409. doi: 10.1001/jamapsychiatry.2018.0013. No abstract available.
- Isaksson J, Nilsson KW, Nyberg F, Hogmark A, Lindblad F. Cortisol levels in children with attention-deficit/hyperactivity disorder. J Psychiatr Res. 2012 Nov;46(11):1398-405. doi: 10.1016/j.jpsychires.2012.08.021. Epub 2012 Sep 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2472/CE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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