An observational study in Attention Deficit Hyperactivity Disorder, sponsored by Università degli Studi di Sassari. Completed at 2 sites in Italy. Open to participants aged 3 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Università degli Studi di Sassari · Observational
To analyze heterogeneity in ADHD experts in last decade advised to look beyond the lists of existing symptoms towards phenotypic measures that can be represented dimensionally and have well-theorized relationships with neurobiological systems, (Sonuga-Barke \& Halperin, 2010; Insel et al, 2010; Fair D, Bathula D, Nikolas M, Nigg JT, 2012; Georgiades S, Szatmari P, Boyle M, 2013; Sanislow CA, Pine DS, Quinn KJ, et al, 2013). This is the nucleus of RDoC aims because children and adolescents with ADHD can be characterized in terms of several features that are best represented as dimensions and have well-theorized relationships to biological systems (Cuthbert \& Insel, 2013).
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?
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This study's enrollment of 120 is below the median of 134 across 122 observational studies indexed under Hyperkinesis.
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We enrolled 67 individuals with ADHD and 70 typically developing youths (TDY) aged between 4 and 16 years. Individuals with ADHD were recruited from the Child and Adolescent Neuropsychiatry Unit, University of Sassari, Italy.
ADHD group:
TDY (Typically Developing Control) - group:
Exclusion Criteria:
ADHD group:
TDY (Typically Developing Control) - group:
120 subject: 53 with an ADHD clinical diagnosis and 57 typically developing controls aged between 3 and 16 years old.
Diagnostic Test: Swanson, Noolan and Phelham - IV edition (SNAP-IV); Conners' Parent Rating Scales (CPRS)
* Ratings on the Swanson, Nolan and Pelham Evaluation Scale - IV (Bussing et al., 2008), were assessed during baseline visit for participants at the time of research assessment, to exclude the presence of ADHD symptoms in the healthy subjects. This scale is composed of 26 items for ADHD symptoms and ODD and was administered at baseline and at follow-up visit. * Temperament assessment: we used the Mary Rothbart's Temperament Questionnaire, a caregivers' report measure designed to provide a detailed assessment of temperament. * ADHD Rating scales: the Long Version of Conners' Parent Rating Scale (Conners et al., 1998) was used to quantify ADHD comorbidity symptoms, as ODD and Anxiety traits, in the children and adolescents with ADHD. * Salivary cortisol: Sampling was performed during one ordinary weekday between 7 and 8 o'clock, within 60' after nocturnal awakening.
Also known as: Rothbart Temperament questionnaires
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.
Specifically: * we first investigate whether temperament dimensions and awakening cortisol level differ between youths with ADHD and controls and correlate with ADHD symptoms (inattention and hyperactivity-impulsivity). * Second, we examine whether the three temperament dimensions are associated with awakening cortisol levels.
Time frame: six months
To evaluate the association between cortisol levels and co-morbidity severity symptoms.
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.
Time frame: six months
Plan to share: No — Statistical Analyses were performed using the software R (version R 3.4.1). Analysis of variance covaring for sex (ANCOVA) was used to compare the two groups on the three temperament dimensions and on the awakening cortisol levels. A series of linear regression model analyses were used to test the association of temperament dimensions and cortisol levels with ADHD traits and the oppositional-defiant and anxiety traits. To test the difference between cortisol levels on- and off- methylphenidate treatment in participants with ADHD, we performed repeated measures analysis of variance. Before analysis, cortisol levels were log-transformed to normal. Analyses were then carried out using standardized scores for all measures.
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Università degli Studi di Sassari