Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale and Epilepsy

Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study

The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences.

In these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will then optimize our methodological approach for a therapeutic trial.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Other: ADHD Rating Scale-IV

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Service de Neurologie pédiatrique, CHU d'Amiens
  • Angers, France, 49033
    • Service de Neurologie Pédiatrique, CHU d'Angers
  • Besançon, France, 25030
    • Service de Neurologie pédiatrique, CHU de Besançon
  • Bordeaux, France, 33076
    • Unité de Neurologie de l'Enfant et de l'Adolescent, Hôpital Pellegrin
  • Bron, France, 69677
    • Institut des Epilepsies de l'Enfant et de l'Adolescent, Hôpital Femme Mère Enfant
  • Bron, France, 69677
    • Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer
  • Chambéry, France, 73011
    • Service d'épileptologie pédiatrique, CHR de Chambéry
  • Lyon, France, 69002
    • Cabinet Médical du Dr ISNARD
  • Marseille, France, 13385
    • Service de Neurologie pédiatrique, Hôpital de la Timone
  • Paris, France, 75019
    • Service de Neurologie Pédiatrique, Hôpital Robert-Debré
  • Paris, France, 75743
    • Service de Neurologie pédiatrique, Hôpital Neckert-Enfants malades
  • Rennes, France, 35203
    • Service de Pédiatrie, Hôpital Sud
  • Strasbourg, France, 67098
    • Centre Référent des Epilepsies Rares, Hôpital de Hautepierre
  • Toulouse, France, 31059
    • Service de Neurologie Pédiatrique, Hôpital des Enfants
  • Tours, France, 37044
    • Service de Neurologie Pédiatrique, CHU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• children aged 6 to 15 years and 11 months;
• male or female;
• with a diagnosis of ADHD : predominantly inattentive or combined hyperactive-impulsive and inattentive according to the DSM IV criteria;
• children who agreed to participate to the protocol and whose legal representatives have clearly expressed their non-opposition to participate.

Exclusion Criteria:

• Patients below 6 years old or patients older than 16 years;
• with a diagnosis of ADHD predominantly hyperactive-impulsive subtype ADHD according to the DSM IV criteria;
• mental retardation defined by a score < 70 at the verbal comprehension index and the perceptual reasoning score of the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV)
• established diagnosis of any psychiatric co-morbidity other than ADHD according to the DSM IV criteria (pervasive developmental disorders including autism, bipolar disorder, psychotic disorder).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated patients; Patients for whom ADHD treatment is introduced at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore	Other: ADHD Rating Scale-IV; ADHD Rating Scale-IV test
Experimental: Non treated patients; Patients for whom no ADHD treatment is required at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore	Other: ADHD Rating Scale-IV; ADHD Rating Scale-IV test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the ADHD rating scale IV inattention subscore	Evolution of the ADHD rating scale IV inattention subscore in treated versus non treated patients, after 12 to 16 weeks.	Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the ADHD rating scale IV global score	Evolution of the ADHD rating scale IV global score in treated versus non treated patients, after 12 to 16 weeks.	Change from baseline in ADHD rating scale IV global score at 12 to16 weeks
Evolution of the ADHD rating scale IV hyperactivity subscore	Evolution of the ADHD rating scale IV hyperactivity subscore in treated versus non treated patients, after 12 to 16 weeks.	Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sylvain RHEIMS, MD, Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Mercier C, Roche S, Gaillard S, Kassai B, Arzimanoglou A, Herbillon V, Roy P, Rheims S. Partial validation of a French version of the ADHD-rating scale IV on a French population of children with ADHD and epilepsy. Factorial structure, reliability, and responsiveness. Epilepsy Behav. 2016 May;58:1-6. doi: 10.1016/j.yebeh.2016.02.016. Epub 2016 Mar 15.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 24, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimated): November 30, 2011

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Epilepsy; Attention deficit; ADHD rating scale IV
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Epilepsy; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 2011.682/25