Early Interventions in Children With Attention Deficit/Hyperactivity Disorder

NCT02807870 | Completed Phase 4

• 1 other identifier: 466859/2014-7
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity; Preschool Child

Keywords

Parental training; Preschool age; Attention Deficit/Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (3)

• Change in attention deficit and hyperactivity symptoms

  The child will be assessed with the Swanson, Nolan and Pelham (SNAP) scale.

  Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention

• Change in symptom severity

  The child will be assessed by a blinded rater with the Clinical Global Impressions Scale (CGI).

  Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention

• Change in social and psychiatric functioning

  The child will be assessed with the Children's Global Assessment Scale (CGAS).

  Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention

Secondary Outcomes (6)

• Change in executive functions

  Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention

• Adverse effects of the treatment

  Along 8 weeks.

• Evaluate ADHD symptoms that may influence treatment response and adherence

  Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention

• Evaluate Depression symptoms that may influence treatment response and adherence

  Baseline, after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention

• Changes in irritability symptoms

  Baseline and after 8 weeks (post intervention) and follow-up 1, 2 and 3 years after the end of the intervention

Other Outcomes (7)

• Changes in Midbrain, black substance, red nucleus, median raphe, third ventricle, thalamus, anterior horn of lateral ventricles, caudate nucleus and lentiform nucleus

  Baseline and after 8 weeks (post intervention).

• Changes in Expressed Emotion

  Baseline and after 8 weeks (post intervention).

• Changes in oscillatory neural connectivity

  Baseline and after 8 weeks (post-intervention)

Study Arms (3)

Methylphenidate-psychoeducational group

EXPERIMENTAL

Methylphenidate treatment with a initial dosage of 0,3 mg/kg per day (weekly dosage adjustments) and weekly psychoeducational groups for parents during 8 weeks.

Drug: Methylphenidate; Other: Psychoeducational groups for parents

Parental training-placebo pill

EXPERIMENTAL

Weekly parental training conducted by behavioral psychologists and placebo pill during 8 weeks.

Behavioral: Parental training; Drug: Placebo pill

Psychoeducational group-placebo pill

PLACEBO COMPARATOR

Weekly psychoeducational groups for parents and placebo pill during 8 weeks.

Other: Psychoeducational groups for parents; Drug: Placebo pill

Interventions

Methylphenidate DRUG

Methylphenidate treatment with a initial dosage of 0,3 mg/kg per day (weekly dosage adjustments).

Methylphenidate-psychoeducational group

Parental training BEHAVIORAL

Weekly parental training conducted by behavioral psychologists.

Parental training-placebo pill

Psychoeducational groups for parents OTHER

Weekly psychoeducational groups conducted by educators.

Methylphenidate-psychoeducational group; Psychoeducational group-placebo pill

Placebo pill DRUG

Placebo pill during 8 weeks.

Parental training-placebo pill; Psychoeducational group-placebo pill

Eligibility Criteria

• Age: 47 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Attention deficit hyperactivity disorder DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) diagnosis
• Score above 32 on the Swanson, Nolan, and Pelham-IV scale
• Child is registered in a school or day care center
• Children without the use of stimulants or any psychotropic in the last 30 days

You may not qualify if:

• Intelligence quotient \<70
• The presence of clinical condition or history of neurological disorder or head trauma with conscience loss
• The presence of affective and psychotic disorders, as well as autism spectrum disorders.
• The absence of a legal representative with the capacity to understand the study objectives and the instructions related to its participation.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 01060-970, Brazil

Location

Related Publications (1)

• Sugaya LS, Salum GA, de Sousa Gurgel W, de Morais EM, Del Prette G, Pilatti CD, Dalmaso BB, Leibenluft E, Rohde LA, Polanczyk GV. Efficacy and safety of methylphenidate and behavioural parent training for children aged 3-5 years with attention-deficit hyperactivity disorder: a randomised, double-blind, placebo-controlled, and sham behavioural parent training-controlled trial. Lancet Child Adolesc Health. 2022 Dec;6(12):845-856. doi: 10.1016/S2352-4642(22)00279-6. Epub 2022 Oct 26.

  PMID: 36306807 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Guilherme V Polanczyk

  University of Sao Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: June 30, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)