Attention and Pain in Children With and Without Attention Deficit and/or Hyperactivity Disorder

NCT04766580 | Unknown

• 1 other identifier: 2020-3357
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

In Quebec, there has been an important increase of Attention Deficit Hyperactivity Disorder (ADHD) diagnosis since 2015. ADHD symptoms, related to behavioural and/or concentration difficulties, are very similar to other disorders symptoms, such as anxiety and depression, and have a significant impact on students' academic success and future life. Adults (parent, teacher, coach) expectations towards a child's abilities are consciously or unconsciously perceived by the child, influence his expectations of his own abilities, and thus his academic performance (Pygmalion effect). The child and his entourage's expectations are therefore a major factor to consider, especially in school-age children. According to ADHD studies, some brain areas involved in pain regulation and in attention cognitive abilities develop at a slower rate in children with ADHD than the other children. Considering the deleterious consequences generated by the symptoms of this disorder, the research project aims to better understand the role of expectations in children with ADHD in a medical (pain) and school (attention abilities) context. It also aims to contribute to better understand the role of the brain on the expectations effect and ADHD. In this study, children expectations will be modulated while pain experiments and cognitive task will be realized by children with and without ADHD. Brain measures will also be assessed with advanced techniques. Thus, we hope that the results will help improve intervention strategies in these contexts to ensure better support for children with ADHD, with a distant goal of contributing to the development of stronger tools for differential diagnostics.

Conditions

Attention Deficit Disorder With Hyperactivity; Placebo Effect; Nocebo Effect; Pain

Keywords

Placebo; Nocebo; Attention; Pain; Children; Imaging

Outcome Measures

Primary Outcomes (2)

• Placebo and nocebo effect on pain

  Pain (thermal) will be generated using an experimental pain paradigm using a thermode (heat). Perceived pain level will be assessed using a standardized tool; a computer-connected Visual Analogue Scale (VAS). The participant can score the pain sensation with a 0 to 10 scale, where 0 means "no pain" and 10 "the most intense pain tolerable".

  Change from pre-test pain sensation to the pain sensation after the two "medications" (collected in one visit in March-April during the pre-test, after the placebo and after the nocebo. Data will be reported within the following 6 months.

• Placebo and nocebo effect on attention abilities

  Attention abilities will be assessed using equivalent randomly assigned attentional tasks, the Stop signal task (SST). The measured outcomes are the reaction times in milisecond (ms) and the proportion of correct/incorrect reactions.

  Change from pre-test results to the results observed after the two "medications" (collected in one visit in March-April during the pre-test, after the placebo and after the nocebo. Data will be reported within the following 6 months.

Secondary Outcomes (12)

• Neuroanatomical measures : DLPFC gray matter volume

  The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months.

• Neuroanatomical measures : DLPFC neural activity

  The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months.

• Neuroanatomical measures : DLPFC neural connection

  The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months.

• Neuroanatomical measures : DLPFC vascularisation

  The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months.

• Neurophysiological measures: inhibitory mechanisms

  The outcome measure should be assessed during the visit 2, which should occur in 3-4 months. Data should be reported within the following 6 months.

Study Arms (2)

Children with ADHD group

EXPERIMENTAL

The same protocol is used for both groups

Behavioral: Placebo and nocebo effect

Children with no ADHD group

ACTIVE COMPARATOR

The same protocol is used for both groups

Behavioral: Placebo and nocebo effect

Interventions

Placebo and nocebo effect BEHAVIORAL

The intervention focuses on the speech and instructions given with each placebo (positive for the placebo effect and negative for the nocebo effect)

Also known as: Pygmalion effect

Children with ADHD group; Children with no ADHD group

Eligibility Criteria

• Age: 8 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child 8 or 9 years old
• ADHD diagnosis confirmed by a qualified health professional (for the ADHD group only).
• Understand French

You may not qualify if:

• Other neurological problems other than ADHD
• Diagnosis of a psychological disorder
• Intellectual disability

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche sur le vieillissement (CdRV)

Sherbrooke, Quebec, J1H 4C4, Canada

RECRUITING

Related Publications (12)

• Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry. 2007 Jun;164(6):942-8. doi: 10.1176/ajp.2007.164.6.942.

  PMID: 17541055 BACKGROUND

• Sayal K, Prasad V, Daley D, Ford T, Coghill D. ADHD in children and young people: prevalence, care pathways, and service provision. Lancet Psychiatry. 2018 Feb;5(2):175-186. doi: 10.1016/S2215-0366(17)30167-0. Epub 2017 Oct 9.

  PMID: 29033005 BACKGROUND

• Merten EC, Cwik JC, Margraf J, Schneider S. Overdiagnosis of mental disorders in children and adolescents (in developed countries). Child Adolesc Psychiatry Ment Health. 2017 Jan 17;11:5. doi: 10.1186/s13034-016-0140-5. eCollection 2017.

  PMID: 28105068 BACKGROUND

• Janiaud P, Cornu C, Lajoinie A, Djemli A, Cucherat M, Kassai B. Is the perceived placebo effect comparable between adults and children? A meta-regression analysis. Pediatr Res. 2017 Jan;81(1-1):11-17. doi: 10.1038/pr.2016.181. Epub 2016 Sep 20.

  PMID: 27648807 BACKGROUND

• Rainville P, Bao QVH, Chretien P. Pain-related emotions modulate experimental pain perception and autonomic responses. Pain. 2005 Dec 5;118(3):306-318. doi: 10.1016/j.pain.2005.08.022. Epub 2005 Nov 14.

  PMID: 16289802 BACKGROUND

• Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol. 2008;59:565-90. doi: 10.1146/annurev.psych.59.113006.095941.

  PMID: 17550344 BACKGROUND

• Benedetti F, Pollo A, Lopiano L, Lanotte M, Vighetti S, Rainero I. Conscious expectation and unconscious conditioning in analgesic, motor, and hormonal placebo/nocebo responses. J Neurosci. 2003 May 15;23(10):4315-23. doi: 10.1523/JNEUROSCI.23-10-04315.2003.

  PMID: 12764120 BACKGROUND

• Friedman LA, Rapoport JL. Brain development in ADHD. Curr Opin Neurobiol. 2015 Feb;30:106-11. doi: 10.1016/j.conb.2014.11.007. Epub 2014 Dec 9.

  PMID: 25500059 BACKGROUND

• Bruckmann S, Hauk D, Roessner V, Resch F, Freitag CM, Kammer T, Ziemann U, Rothenberger A, Weisbrod M, Bender S. Cortical inhibition in attention deficit hyperactivity disorder: new insights from the electroencephalographic response to transcranial magnetic stimulation. Brain. 2012 Jul;135(Pt 7):2215-30. doi: 10.1093/brain/aws071. Epub 2012 Apr 3.

  PMID: 22492560 BACKGROUND

• Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

  PMID: 6226917 BACKGROUND

• McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-443. doi: 10.1016/0304-3959(95)00171-9.

  PMID: 8783307 BACKGROUND

• Kujirai T, Caramia MD, Rothwell JC, Day BL, Thompson PD, Ferbert A, Wroe S, Asselman P, Marsden CD. Corticocortical inhibition in human motor cortex. J Physiol. 1993 Nov;471:501-19. doi: 10.1113/jphysiol.1993.sp019912.

  PMID: 8120818 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Pain

Interventions

Nocebo Effect

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Placebo Effect; Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Guillaume guillaume.leonard2@usherbrooke.ca, pht., PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen-Édith Belleï-Rodriguez, ps.ed., MSc

CONTACT

+1 819-780-2220; carmen-edith.bellei-rodriguez@usherbrooke.ca

Guillaume Léonard, pht., PhD

CONTACT

+1 819-780-2220; guillaume.leonard2@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants think they are taking two medications (if not in the "control group"), but the care provider and investigators know that only placebos (a placebo and a nocebo) are given.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All the participants will take "two medications" (which are all placebos). The order of the "medications" are randomized.

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 23, 2021
• Study Start: February 17, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)