Temperament Dimensions and Awakening Salivary Cortisol Levels in ADHD.

March 27, 2020 updated by: ALESSANDRA CARTA, Università degli Studi di Sassari

Association Between Temperament Dimensions and Awakening Salivary Cortisol Levels in Children and Adolescents With Attention Deficit Hyperactivity/Impulsivity Disorder (ADHD)

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).

Study Overview

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

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sassari, Italy, 07100
        • Alessandra Carta
      • Sassari, Italy, 07100
        • Complex Operating Unit of Child and Adolescent Neuropsychiatry - University of Sassari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  1. 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.
  2. 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:

  1. 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.
  2. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
  • 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.
Other Names:
  • Rothbart Temperament questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
six months
To evaluate the association between cortisol levels and co-morbidity severity symptoms.
Time Frame: six months
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.
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ALESSANDRA CARTA, Sassari University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2017

Primary Completion (Actual)

September 29, 2017

Study Completion (Actual)

January 12, 2018

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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