Title {1} | Efficacy of Cognitive-Behavioral Therapy (CBT) on aggressive behavior in children with ADHD and emotion dysregulation: study protocol of a randomized controlled trial |
Trial registration {2a and 2b}. | Clinicaltrials.gov. Number: NCT03176108. Registered on June 5, 2017 |
Protocol version {3} | August 8, 2018; version n. 3 |
Funding {4} | The trial is funded by Montpellier University Hospital, France |
Author details {5a} |
Vacher, C1,2,3., Romo, L2,5.,Dereure, M4., Soler, M4., Picot, M.C4,6., & Purper-Ouakil, D1,3 1 Service Médecine Psychologique de l’Enfant et de l’Adolescent, Centre Hospitalo-Universitaire de Montpellier, Montpellier, Hérault, France 2 CLIPSYD EA-4430, UFR Sciences Psychologiques et Sciences de l’Education, Université Paris Nanterre, Nanterre, Hauts de Seine, France 3 INSERM U 1018, CESP, Psychiatrie du développement – Evaluer et traiter les troubles émotionnels et du neurodéveloppement (ETE-ND), Montpellier, France 4 Unité de Recherche Clinique et Epidémiologie, Département de l’Information Médicale, Centre Hospitalo-Universitaire de Montpellier, Montpellier, Hérault, France 5 Service de Pathologies professionnelles et de l’environnement, Assistance Publique des Hôpitaux de Paris, Hôpital Universitaire Raymond Poincaré, Garches, France 6 Centre d’Investigation Clinique, Hôpital Saint Eloi, Centre Hospitalo-Universitaire de Montpellier, Montpellier, Hérault, France |
Name and contact information for the trial sponsor {5b} |
Vacher Cécile c-vacher@chu-montpellier.fr |
Role of sponsor {5c} | The sponsor of this trial is Montpellier University Hospital and its team collects, analyzes and interprets the data; and writes the report in collaboration with Prof Romo. The decision to submit the report for publication comes from the principal research investigator. |