Early Interventions in Children With Attention Deficit/Hyperactivity Disorder
Status:
Completed
Trial end date:
2020-06-30
Target enrollment:
Participant gender:
Summary
Introduction: Attention deficit/hyperactivity disorder (ADHD) is one of the most prevalent
mental disorders in children and is associated with important negative functional outcomes
throughout development. The first signs and symptoms become apparent in preschool age.
Therefore, early interventions in this population have the potential of limiting the
disorder's negative impact and preventing future impairments in affected individuals. The
first-choice medication for treating ADHD is methylphenidate, which has evidence of efficacy
and safety in preschool children. However, non-evidence based worries and pressure from the
media placed parent training as the first-line treatment for ADHD in clinical guidelines.
Parent training is a behavioral intervention implemented with the parents, with weekly
sessions for 8 weeks, adequate for treating ADHD dysfunctional symptoms and behaviors.
However, the level of evidence for this intervention is reduced. Furthermore, the need of
trained therapists in the public health system, added to the difficulties on adherence and
comprehension from parents, limit its generalization and raise questions regarding its
indications. Until now, no study has compared pharmacological treatment with methylphenidate
to parent training in preschool children with ADHD regarding their clinical efficacy and
cost-effectiveness. Moreover, no study has evaluated the impact of pharmacological
intervention and psychotherapy on neurobiological mechanisms of ADHD, which is crucial for
determining their impact on neurodevelopment.
Objectives: This is a double-blind randomized clinical trial that aims to evaluate the
efficacy, tolerability, and acceptability of treatment with methylphenidate compared to
parental training and placebo in preschool children with ADHD.
Methods: This study will be a randomized, double-blind, parallel-group, evaluating two active
interventions and placebo control group. One hundred and fifty children aged 3 years and 11
months and 5 years and 11 months, diagnosed with ADHD, will be randomized to receive
treatment with methylphenidate and information (50 children), parental training and treatment
with placebo medication (50 children) or belong to active control group with educational
information for parents and placebo treatment with no treatment (active control, 50
children). The treatment will last eight weeks, the neurobiological outcomes will be assessed
before and after treatment and clinical outcomes will be assessed at weeks 0, 5 and 9. After
the end of treatment, all participants will be invited to participate in a 3 years' annual
follow-up. 50 children with typical development will also be evaluated in relation to
neurobiological measures.
Implications: This study proposes an innovative and relevant analysis, which will enable the
field to advance the knowledge of biological mechanisms related to ADHD and to treatment
response. Also, the study will expand the evidence to guide early prevention strategies and
early intervention.
Phase:
Phase 4
Details
Lead Sponsor:
University of Sao Paulo
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico