Recruiting

Observational Study

Sponsor:

Université de Sherbrooke

Code:

NCT04766580

Conditions

Attention Deficit Disorder With Hyperactivity

Placebo Effect

Nocebo Effect

Pain

Eligibility Criteria

Sex: All

Age: 8 - 9

Healthy Volunteers: Accepted

Interventions

Placebo and nocebo effect

Study Details

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

Study ID

NCT04766580

Start date

Feb 17, 2021

Status verified date

Jul, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 9

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Children with ADHD group

The same protocol is used for both groups

active comparator: Children with no ADHD group

The same protocol is used for both groups

Interventions

Placebo and nocebo effect

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

Primary outcome measure

  • Placebo and nocebo effect on pain [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

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

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

Locations

Centre de recherche sur le vieillissement (CdRV)

Recruiting

Sherbrooke, Quebec, Canada, J1H 4C4

Contacts

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

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

More Information

Sponsor

Université de Sherbrooke

Last update posted

Jul 28, 2022

Last verified

Jul, 2022

Keywords

  • Placebo
  • Nocebo
  • Attention
  • Pain
  • Children
  • Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2022-07-28.