Temperament Dimensions and Awakening Salivary Cortisol Levels in ADHD.

NCT04326543 | Completed DMC

• 1 other identifier: 2472/CE
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  six months

Study Arms (1)

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.

Diagnostic Test: Swanson, Noolan and Phelham - IV edition (SNAP-IV); Conners' Parent Rating Scales (CPRS)

Interventions

Swanson, Noolan and Phelham - IV edition (SNAP-IV); Conners' Parent Rating Scales (CPRS) DIAGNOSTIC_TEST

* 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

ADHD and typically developing controls

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (2)

Alessandra Carta

Sassari, 07100, Italy

Location

Complex Operating Unit of Child and Adolescent Neuropsychiatry - University of Sassari

Sassari, 07100, Italy

Location

Related Publications (3)

• 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.

  PMID: 25006969 BACKGROUND

• 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.

  PMID: 29516086 RESULT

• 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.

  PMID: 22974590 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva sample to tests awakening cortisol levels.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• ALESSANDRA CARTA

  Sassari University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD student

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 30, 2020
• Study Start: January 18, 2017
• Primary Completion: September 29, 2017
• Study Completion: January 12, 2018
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)