Association Between Temperament Dimensions and Awakening Salivary Cortisol Levels in Children and Adolescents With Attention Deficit Hyperactivity/Impulsivity Disorder (ADHD)
Sponsor study identifier
observational
120
1 country
2
Study Start
January 18, 2017
Actual (reported)Primary Completion
September 29, 2017
Actual (reported)Study Completion
January 12, 2018
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 12, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 18, 2017
Actual (reported)September 29, 2017
Actual (reported)January 12, 2018
Actual (reported)March 25, 2020
Actual (reported)March 30, 2020
Actual (reported)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
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.
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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.
Alessandra Carta
Sassari, 07100, Italy
Complex Operating Unit of Child and Adolescent Neuropsychiatry - University of Sassari
Sassari, 07100, Italy
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.
Saliva sample to tests awakening cortisol levels.
ALESSANDRA CARTA
Sassari University
120 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2020
First Posted
March 30, 2020
Study Start
January 18, 2017
Actual (reported)Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder
Contact the study team to confirm eligibility.
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.
Primary Completion
September 29, 2017
Actual (reported)Study Completion
January 12, 2018
Actual (reported)Last Updated
March 30, 2020
Record last verified: 2020-03
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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