Comparison of Effectiveness of Working Memory Cognitive Rehabilitation with Methylphenidate ِDrug on Emotional Processing in Children with Attention deficit hyperactivity disorder (ADHD)
Design
Clinical trial with control group with parallel, double-blind and randomized groups, phase 3 on 30 children with ADHD. Random numbers table was used for randomization.
Settings and conduct
The study site will be the pediatric ward of Ibn Sina Psychiatric Hospital in Mashhad, Iran. This will be a double blind study that did not know the outcome of the intervention and analyzed the data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 7 to 12 years old with ADHD; Conscious parental consent
Non-inclusion criteria: undergoing psychological or other medical treatment
Intervention groups
Intervention group: Doing cognitive training to strengthen and rehabilitate working memory using Captain Log software For 12 sessions, twice a week, each session will be done for 20 minutes. Captain Log software is used to develop children's cognitive skills.
Control group: Pharmacological treatment with methylphenidate tablet in the amount of 0.5 mg/kg body weight of the child in a daily dose for 45 days.
Main outcome variables
Emotional processing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210304050572N1
Registration date:2021-05-14, 1400/02/24
Registration timing:prospective
Last update:2021-05-14, 1400/02/24
Update count:0
Registration date
2021-05-14, 1400/02/24
Registrant information
Name
Farah Alizadeh Jouimandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2709
Email address
alizadehjf971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Working Memory Cognitive Rehabilitation and Methylphenidate ِon Emotional Processing in Children with ADHD
Public title
Working Memory Cognitive Rehabilitation in Children with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 7 to 12 years
Suffering from ADHD
Parental informed consent
Exclusion criteria:
Chronic medical problems such as diabetes, epilepsy, etc.
Psychiatric disorders other than ADHD
Undergoing psychological or other medical treatment
Age
From 7 years old to 12 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: Write the names of 30 children from 1 to 30, respectively, and then assign them one in between in two groups using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome Assessor: The person in charge of testing and the outcome assessor does not know the type of intervention in children.
Data Analyzer: The data is coded and the data analyzer does not know the type of intervention in children.
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
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.482
Health conditions studied
1
Description of health condition studied
Attention Deficit / Hyperactivity Disorder (ADHD)
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Emotional Processing
Timepoint
Before and after intervention
Method of measurement
CBCL Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 15 children with Attention Deficit / Hyperactivity Disorder undergo cognitive rehabilitation exercises during 12 20-minute sessions 20 minutes for six weeks. Cognitive exercises to strengthen and rehabilitate working memory using software Captain Log will be done. Captain Log software is used to develop cognitive skills. This software is based on a range of cognitive educational research and includes 50 programs at multiple levels, which are organized into 3 training sets (attention skills training, memory skills training and problem solving and working memory) within the system. It will be used according to the age of the children by an experienced educational expert.
Category
Rehabilitation
2
Description
Control group: Fifteen children with ADHD are treated with standard methylphenidate tablet at a dose of 0.5 mg / kg daily for 45 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn Sina Hospital
Full name of responsible person
Dr Farah Alizadeh Jouimandi
Street address
Hor Ameli
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Fax
+98 51 3711 2545
Email
alizadehjf971@mums.ac.ir
Web page address
https://sina.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Farah Alizadeh Jouimandi
Position
Psychiatiy Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hor Ameli street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Fax
+98 51 3711 2545
Email
alizadehjf971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Farah Alizadeh Jouimandi
Position
Psychiatry Residentl
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hor Ameli
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Fax
+98 51 3711 2545
Email
alizadehjf971@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Farah Alizadeh Jouimandi
Position
Psychiatry Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hor Ameli
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Fax
+98 51 3711 2545
Email
alizadehjf971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available