<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01692548</url>
  </required_header>
  <id_info>
    <org_study_id>110084</org_study_id>
    <nct_id>NCT01692548</nct_id>
  </id_info>
  <brief_title>Neurofeedback Intervention on the Development of ADHD in Children at Risk</brief_title>
  <official_title>Effect of Neurofeedback Intervention on the Development of ADHD in Children at Risk: a Comparative Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Forty children considered at risk for ADHD (subclinical ADHD) will be randomized to either a&#xD;
      neurofeedback intervention or waiting list.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Attention Deficit Hyperactive Disorder (ADHD) is one of the most common mental disorders&#xD;
      among children. It is associated with an important burden to individuals, their families and&#xD;
      society. ADHD is a chronic condition and the majority of affected individuals presents&#xD;
      symptoms and associated functional deficit through adult life. Although pharmacological&#xD;
      treatment can be easily implemented and are short-term effective, its efficacy tends to&#xD;
      decrease with time and long-term effects are uncertain. Psychosocial treatments tend to be&#xD;
      effective only during treatment delivery and treatment effects are not sustained. New&#xD;
      treatment strategies are required in order to provide better care to ADHD patients. Early&#xD;
      interventions might avoid the development of the disorder, limit its persistency or prevent&#xD;
      associated deficits. The aim of this study is to evaluate the efficacy of a&#xD;
      non-pharmacological intervention for children at risk for ADHD.&#xD;
&#xD;
      This randomized controlled clinical trial has the aim of testing the efficacy of&#xD;
      neurofeedback for children at increased risk for ADHD (subclinical ADHD symptoms). This is&#xD;
      study is a multisite school based trial. Forty children from the 1st to the 4th grade with&#xD;
      subclinical ADHD symptoms will be randomized to neurofeedback or waiting list. Subclinical&#xD;
      ADHD will be defined as having 3-5 out of 9 inattention and/or hyperactivity/impulsivity&#xD;
      symptoms according to parents clinical evaluation (K-SADS-PL) but less than 6 symptoms&#xD;
      according to teachers report (assessed using SNAP-IV) OR 3-5 symptoms according to teachers&#xD;
      report and less than 6 according to parents clinical evaluation. Exclusion criteria includes&#xD;
      IQ lower than 80, severe mental disorder or neurological disease. Treatment will comprise 25&#xD;
      sessions of NF using Slow Cortical Potential training. Children will be invited to attend 2&#xD;
      sessions per week, each session comprises 4 blocs of 20 trials with both activation and&#xD;
      deactivation challenges. Eldith Tharaprax equipment will be used in both sites. The study,&#xD;
      including treatment sessions, will be conducted in schools. Two public schools were selected&#xD;
      to host the study, one in São Paulo and another in Porto Alegre, Brazil. Main outcome will be&#xD;
      parents rating scores for ADHD symptoms (SWAN questionnaire). To avoid bias due to the low&#xD;
      literacy of our population, parents will be assisted by a staff member to fill the SWANs&#xD;
      questionnaires. Second outcomes includes: 1) Performance on computerized tests designed to&#xD;
      measures time processing, basic processing, inhibitory control and executive function and&#xD;
      delay aversion and 2) Pre- post treatment differences on electrophysiological measures (evoke&#xD;
      related potentials during two tasks that requires sustained attention, self-monitoring and&#xD;
      response to attentional prime); 3) conversion to ADHD (incident cases). Outcomes measures&#xD;
      will be assessed prior to treatment start, in after the 13 session, soon after the 25&#xD;
      session, after 6 months of follow-up. Random regression will be used to model each subject's&#xD;
      response against time (from baseline to session 12 and from 12th session to treatment end).&#xD;
      For continuous variables we will compare the average slope of the regression line across the&#xD;
      two groups to test whether the intervention is superior to waiting-list. Proportion of new&#xD;
      cases will be compared across groups using chi square test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ADHD symptoms</measure>
    <time_frame>Baseline; 6 weeks; 3 months; 6 months.</time_frame>
    <description>Measured by the SWAN scale filled by parents.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in performance on computerized tests.</measure>
    <time_frame>Baseline; 6 weeks; 3 months; 6 months.</time_frame>
    <description>Time processing, basic processing, inhibitory control and executive function and delay aversion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EEG measures</measure>
    <time_frame>Baseline; 6 weeks; 3 months; 6 months.</time_frame>
    <description>Pre-post treatment differences on electrophysiological measures (evoke related potentials during two tasks that requires sustained attention, self-monitoring and response to attentional prime)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incident cases.</measure>
    <time_frame>6 months.</time_frame>
    <description>Number of at risk children that actually converts to ADHD diagnosis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>ADHD</condition>
  <arm_group>
    <arm_group_label>Neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neurofeedback: two sessions per week, 30 sessions total.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurofeedback</intervention_name>
    <arm_group_label>Neurofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  From 3 to 5 ADHD symptoms according to DSM-IV&#xD;
&#xD;
          -  Age 6 to 10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already attending treatment for ADHD&#xD;
&#xD;
          -  IQ below 80&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90035003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>May 1, 2013</last_update_submitted>
  <last_update_submitted_qc>May 1, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 3, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas de Porto Alegre</investigator_affiliation>
    <investigator_full_name>larohde</investigator_full_name>
    <investigator_title>Professor of Chlid and Adolescent Psychiatry</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01692548
org study id: 110084
nct id: NCT01692548
lead sponsor: 
has dmc: Yes
Forty children considered at risk for ADHD (subclinical ADHD) will be randomized to either a
      neurofeedback intervention or waiting list.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in ADHD symptoms
time frame: Baseline; 6 weeks; 3 months; 6 months.
description: Measured by the SWAN scale filled by parents.
measure: Change in performance on computerized tests.
time frame: Baseline; 6 weeks; 3 months; 6 months.
description: Time processing, basic processing, inhibitory control and executive function and delay aversion.
measure: Change in EEG measures
time frame: Baseline; 6 weeks; 3 months; 6 months.
description: Pre-post treatment differences on electrophysiological measures (evoke related potentials during two tasks that requires sustained attention, self-monitoring and response to attentional prime)
measure: Incident cases.
time frame: 6 months.
description: Number of at risk children that actually converts to ADHD diagnosis.
arm group label: Neurofeedback
arm group type: Experimental
description: Neurofeedback: two sessions per week, 30 sessions total.
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: Neurofeedback
arm group label: Neurofeedback
criteria: 
gender: All
minimum age: 6 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas de Porto Alegre
investigator full name: larohde
investigator title: Professor of Chlid and Adolescent Psychiatry