NCT02807870.

Study name	Public title: Early interventions in children with attention deficit/hyperactivity disorder Scientific title: Early interventions in children with attention deficit/hyperactivity disorder: randomized controlled trial comparing methylphenidate parental training in treating preschool children with attention deficit /hyperactivity disorder
Methods	Randomised, double‐blind, parallel controlled trial Study duration: 8 weeks
Participants	Sample size (actual): 153 Inclusion criteria Diagnosis of ADHD according to DSM‐5 Score > 32 on the SNAP‐IV Scale; Child registered in a school or day care centre Children without the use of stimulants or any psychotropic in the last 30 days Exclusion criteria Intelligence quotient < 70 Presence of a clinical condition or history of neurological disorder or head trauma with conscience loss Presence of affective and psychotic disorders, as well as autism spectrum disorders Absence of a legal representative with the capacity to understand the study objectives and the instructions related to its participation
Interventions	MPHJ plus educational information for parents Placebo medication plus educational information for parents Placebo medication plus parental training
Outcomes	ADHD symptom severity SNAP scale. Assessed at baseline, 8 weeks (post intervention) and at follow‐up 1, 2 and 3 years after the end of the intervention CPT. Assessed at baseline, 8 weeks (post intervention) and at follow‐up 1, 2 and 3 years after the end of the intervention General behaviour CGI scale. Assessed at baseline, 8 weeks (post intervention) and at follow‐up 1, 2 and 3 years after the end of the intervention Changes in disruptive behaviour symptoms (time frame: baseline, after 8 weeks (post‐intervention) and follow‐up 1, 2 and 3 years after the end of the intervention). The child will be assessed with the MAP‐DB Changes in irritability symptoms (time frame: baseline and after 8 weeks (post‐intervention) and follow‐up 1, 2 and 3 years after the end of the intervention). The child will be assessed with the ARI scale Quality of life CGAS. Assessed at baseline, 8 weeks (post‐intervention) and at follow‐up 1, 2 and 3 years after the end of the intervention
Starting date	June 2016
Contact information	Name: Guilherme V Polanczyk (PI) Affiliation: University of Sao Paulo Medical School
Notes	Sponsor: University of Sao Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico Declaration of interest: not reported