NCT01692548

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

September 12, 2012

Last Update Submit

May 1, 2013

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • Change in ADHD symptoms

    Measured by the SWAN scale filled by parents.

    Baseline; 6 weeks; 3 months; 6 months.

Secondary Outcomes (3)

  • Change in performance on computerized tests.

    Baseline; 6 weeks; 3 months; 6 months.

  • Change in EEG measures

    Baseline; 6 weeks; 3 months; 6 months.

  • Incident cases.

    6 months.

Study Arms (2)

Neurofeedback

EXPERIMENTAL

Neurofeedback: two sessions per week, 30 sessions total.

Other: Neurofeedback

Control

NO INTERVENTION

Interventions

NeurofeedbackOTHER
Neurofeedback

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Already attending treatment for ADHD
  • IQ below 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Chlid and Adolescent Psychiatry

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 25, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

BR(1)