Neurofeedback Intervention on the Development of ADHD in Children at Risk

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
larohde, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01692548
First received: September 12, 2012
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

Forty children considered at risk for ADHD (subclinical ADHD) will be randomized to either a neurofeedback intervention or waiting list.


Condition Intervention
ADHD
Other: Neurofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Neurofeedback Intervention on the Development of ADHD in Children at Risk: a Comparative Study.

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Change in ADHD symptoms [ Time Frame: Baseline; 6 weeks; 3 months; 6 months. ] [ Designated as safety issue: No ]
    Measured by the SWAN scale filled by parents.


Secondary Outcome Measures:
  • Change in performance on computerized tests. [ Time Frame: Baseline; 6 weeks; 3 months; 6 months. ] [ Designated as safety issue: No ]
    Time processing, basic processing, inhibitory control and executive function and delay aversion.

  • Change in EEG measures [ Time Frame: Baseline; 6 weeks; 3 months; 6 months. ] [ Designated as safety issue: No ]
    Pre-post treatment differences on electrophysiological measures (evoke related potentials during two tasks that requires sustained attention, self-monitoring and response to attentional prime)

  • Incident cases. [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
    Number of at risk children that actually converts to ADHD diagnosis.


Enrollment: 36
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neurofeedback
Neurofeedback: two sessions per week, 30 sessions total.
Other: Neurofeedback
No Intervention: Control

Detailed Description:

Attention Deficit Hyperactive Disorder (ADHD) is one of the most common mental disorders among children. It is associated with an important burden to individuals, their families and society. ADHD is a chronic condition and the majority of affected individuals presents symptoms and associated functional deficit through adult life. Although pharmacological treatment can be easily implemented and are short-term effective, its efficacy tends to decrease with time and long-term effects are uncertain. Psychosocial treatments tend to be effective only during treatment delivery and treatment effects are not sustained. New treatment strategies are required in order to provide better care to ADHD patients. Early interventions might avoid the development of the disorder, limit its persistency or prevent associated deficits. The aim of this study is to evaluate the efficacy of a non-pharmacological intervention for children at risk for ADHD.

This randomized controlled clinical trial has the aim of testing the efficacy of neurofeedback for children at increased risk for ADHD (subclinical ADHD symptoms). This is study is a multisite school based trial. Forty children from the 1st to the 4th grade with subclinical ADHD symptoms will be randomized to neurofeedback or waiting list. Subclinical ADHD will be defined as having 3-5 out of 9 inattention and/or hyperactivity/impulsivity symptoms according to parents clinical evaluation (K-SADS-PL) but less than 6 symptoms according to teachers report (assessed using SNAP-IV) OR 3-5 symptoms according to teachers report and less than 6 according to parents clinical evaluation. Exclusion criteria includes IQ lower than 80, severe mental disorder or neurological disease. Treatment will comprise 25 sessions of NF using Slow Cortical Potential training. Children will be invited to attend 2 sessions per week, each session comprises 4 blocs of 20 trials with both activation and deactivation challenges. Eldith Tharaprax equipment will be used in both sites. The study, including treatment sessions, will be conducted in schools. Two public schools were selected to host the study, one in São Paulo and another in Porto Alegre, Brazil. Main outcome will be parents rating scores for ADHD symptoms (SWAN questionnaire). To avoid bias due to the low literacy of our population, parents will be assisted by a staff member to fill the SWANs questionnaires. Second outcomes includes: 1) Performance on computerized tests designed to measures time processing, basic processing, inhibitory control and executive function and delay aversion and 2) Pre- post treatment differences on electrophysiological measures (evoke related potentials during two tasks that requires sustained attention, self-monitoring and response to attentional prime); 3) conversion to ADHD (incident cases). Outcomes measures will be assessed prior to treatment start, in after the 13 session, soon after the 25 session, after 6 months of follow-up. Random regression will be used to model each subject's response against time (from baseline to session 12 and from 12th session to treatment end). For continuous variables we will compare the average slope of the regression line across the two groups to test whether the intervention is superior to waiting-list. Proportion of new cases will be compared across groups using chi square test.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • From 3 to 5 ADHD symptoms according to DSM-IV
  • Age 6 to 10

Exclusion Criteria:

  • Already attending treatment for ADHD
  • IQ below 80
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692548

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
  More Information

No publications provided

Responsible Party: larohde, Professor of Chlid and Adolescent Psychiatry, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01692548     History of Changes
Other Study ID Numbers: 110084
Study First Received: September 12, 2012
Last Updated: May 1, 2013
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Brazil: Ministry of Health

ClinicalTrials.gov processed this record on July 24, 2014