Effect of add Neurofeedback to Ritalin in the treatment of children and adolescents with attention deficit-hyperactivity disorder
Design
Randomized clinical trial
Settings and conduct
Children Psychiatric Clinic of Ibn Sina Hospital in Mashhad.Children referred by pediatric psychiatrist about the interview and the detection rate and have been treated with Ritalin are studied. After obtaining the informed consent of their legal guardians, randomly using the envelope enclosed in two groups of case and Control Division. Before the start of the study, parental and teacher canners questionnaire in both groups will be completed. the case, added on the treatment with Ritalin, treated with 20 45-minute session of Neurofeedback (3 times a week) are supposed to be the control group treated with Ritalin. At the end of the study parents and teachers canners questionnaire again in both groups.
Participants/Inclusion and exclusion criteria
42 children with attention deficit and hyperactivity disorder, Their age ranges from 5 to 15 years old and they have been receiving Ritalin for ADHD treatment , and informed consent has been completed by legal guardians. Exit criteria include the patient's unwillingness to continue to participate in a research project for systemic and psychiatric illnesses.
Intervention groups
Intervention group: children and adolescents with ADHD treated with Ritalin, they get a 45-minute 20sessions (three sessions per week) Neurofeedback.treatment-drugs Control group:children and adolescents with ADHD treated with Ritalin
Main outcome variables
Effect of add Neurofeedback in the treatment of children and adolescents with ADHD.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180723040568N1
Registration date:2018-12-29, 1397/10/08
Registration timing:registered_while_recruiting
Last update:2018-12-29, 1397/10/08
Update count:0
Registration date
2018-12-29, 1397/10/08
Registrant information
Name
fatemeh zahedian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3700 2310
Email address
zahedianf941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of add Neurofeedback to Ritalin in the treatment of children and adolescents with attention deficit-hyperactivity disorder
Public title
Effect of add Neurofeedback to Ritalin in the treatment of children and adolescents with attention deficit-hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ADHD based on DSM-5 criteria
aged 7-12 years
Complete consent form by parent or guardian
Normal IQ
Exclusion criteria:
En The patient's unwillingness to participating in the research project
Systemic disease
Interventional psychiatric illness
intellectual disability
Age
From 6 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected through available sampling. They are randomly divided into two groups of case and control according to the random numbers table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Ghoreishi Department, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9175845643
Approval date
2016-05-07, 1395/02/18
Ethics committee reference number
IR.MUMS.REC.1395.81
Health conditions studied
1
Description of health condition studied
Attention- Deficit Hyperactivity Disorders
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
The symptoms of attention deficit hyperactivity disorder/attention deficit and impulsivity in children and adolescents with ADHD .
Timepoint
The beginning and end of the study
Method of measurement
parents and teacher Canners questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Twenty 45 minute sessions, three times a week gets added to the treatment with Ritalin .
Category
Treatment - Devices
2
Description
Control group: Children and adolescents with ADHD treated with Ritalin