Comparison
of the effects of computer-assisted cognitive rehabilitation treatment
and taking Methylphenidate (Ritalin) on executive functions and severity of clinical symptoms in children with attention deficit/
hyperactivity disorder.
Objectives: comparison of the effects of computer-assisted cognitive
rehabilitation and taking Methylphenidate (Ritalin) on executive
functions and clinical symptoms of attention-deficit/ hyperactivity
disorder.
Design: matched, randomized, no blind design, second experimental group
as control.
Population: inclusion criteria: ADHD diagnosis; age between 7 and 11;
IQ>85.
Exclusion criteria: sever co-morbid disorder; seizures; IQ<85;
disability; sever medical condition;
sample size: total of 34.
Interventions: computer assisted cognitive
rehabilitation (n=14), taking Methylphenidate (n=20).
Assessment: pre-test, post-test, and an one month follow-up;
measurement instruments: continuous performance test; wechsler digit
span test; span board test; Raven's test; Persian version of tower of London test; Swanson, Nolan, and Pelham
scale (to measure ADHD symptom intensity).
Time: two months period of intervention for both groups; rehabilitation
group received 20 one-hour-sessions of computerized training of
executive functions, and drug therapy group simultaneously received 2 to 3 doses of
Ritalin per day for two months. Original outcome variables: executive
function tasks and the scale of severity of symptoms of attention
deficit/ hyperactivity disorder.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106136794N1
Registration date:2011-08-03, 1390/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-03, 1390/05/12
Registrant information
Name
Morteza Nazifi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3676
Email address
nazifi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, faculty of humanities, Tarbiat Modares university.
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison
of the effects of computer-assisted cognitive rehabilitation treatment
and taking Methylphenidate (Ritalin) on executive functions and severity of clinical symptoms in children with attention deficit/
hyperactivity disorder.
Public title
Comparison
of the computerized cognitive rehabilitation and drug therapy in the
treatment of attention-deficit/ hyperactivity disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion
criteria: receiving ADHD diagnosis using psychiatric interviews and
behavioral rating scales; having an age between 7 and 11 years;
IQ>85.
Exclusion criteria: Having sever co-morbid mental disorders such as
oppositional defiant disorder, autism or asperger syndrom, and
depression; a history of epileptic seizures during past 2 years;
IQ<85; having some type of motor or perceptual disability which
interferes with computer operation; having some kind of Medical
condition which make one to seek immediate treatment.
Age
From 7 years old to 11 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
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
The ethics committee of university of Tarbiat Modares, faculty of humanities, vice chancellor of res
Street address
Faculty of humananities, Tarbiat Modares university, Jalale Ale Ahmad Highway, Nasr Bridge, Tehran, Iran.
City
Tehran
Postal code
139-14115
Approval date
2010-03-13, 1388/12/22
Ethics committee reference number
60/32304
Health conditions studied
1
Description of health condition studied
Disturbance of activity and attention
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Intesity of ADHD, combined subtype
Timepoint
preintervention, postintervention, and one month after intervention has finished.
Method of measurement
Persian version of SNAP-IV scale
2
Description
Intesity of ADHD, hyperactive/ impulsive subtype
Timepoint
preintervention, postintervention, and one month after intervention has finished.
Method of measurement
Persian version of SNAP-IV scale
3
Description
Verbal working memory
Timepoint
preintervention, postintervention, and one month after Intervention has finished.
Method of measurement
Digit span test from the WISC-R IQ test (Wechsler, 1981).
4
Description
Visuo-spatial working memory
Timepoint
preintervention, postintervention, and one month after Intervention has finished.
Method of measurement
Span board task from Wechsler RNI batterey (Kaplan, Fein, Morris, and Delis, 1991).
5
Description
Sustained attention
Timepoint
preintervention, postintervention, and one month after Intervention has finished.
Method of measurement
Persian version of continuous performance test (CPT).
6
Description
Intesity of ADHD, inattentive subtype
Timepoint
preintervention, postintervention, and one month after Intervention has finished.
Method of measurement
Persian version of SNAP-IV scale.
7
Description
Raven's IQ test.
Timepoint
preintervention, postintervention, and one month after Intervention has finished.
preintervention, postintervention, and one month after Intervention has finished.
Method of measurement
Persian version of continuous performance test (CPT).
9
Description
Planning
Timepoint
preintervention, postintervention, and one month after Intervention has finished.
Method of measurement
Persian version of tower of London test.
Secondary outcomes
empty
Intervention groups
1
Description
For first experimental group (computer assisted cognitive rehabilitation): the intervention included 20 hours (20 one-hour-sessions) of executive functions training using a computer. Trained executive functions included: verbal working memory; visuo-spatial working memory; sustained attention; response inhibition; planning and organization; and information processing speed. Total period of intervention was 2 months.
Category
Rehabilitation
2
Description
For second experimental group (drug therapy group): The intervention included 2 or 3 doses of Immediate-release Methylphenidate (Ritalin) per day (each doses included one Ritalin pill). This intervention lasted 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Departement for education of region 4 of Tehran
Full name of responsible person
Rasool Bahrami
Street address
Counselling office, departement for education of region 4 of Tehran, next to the Kerman street, Resalat highway, Tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research, faculty of humanities, Tarbiat Modares University
Full name of responsible person
Dr. Mohamad-Reza Mohamadi
Street address
Faculty of humanities, Tarbiat Modares university, Jalal e Al e Ahmad Highway, Nasr bridge, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, faculty of humanities, Tarbiat Modares University
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Research Institute for education, Ministry of Education
Full name of responsible person
Dr. Majid Qadami
Street address
number 56, shahid Hojat Doost alley, Vesal e Shirazi Street, Keshavarz Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for education, Ministry of Education
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares university
Full name of responsible person
Morteza Nazifi
Position
Doctor of psychology
Other areas of specialty/work
Street address
Departement of psychology, faculty of humanities, Tarbiat Modares university, Jalale Al e Ahmad Highway, Nasr bridge, Tehran.
City
Tehran
Postal code
111-14115
Phone
+98 21 82880
Fax
Email
Pres@modares.ac.ir
Web page address
http://www.modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Morteza Nazifi
Position
Doctor of Pschology
Other areas of specialty/work
Street address
Department of psychology, faculty of humanities, Tarbiat Modares university, Jalal e Al e Ahmad highway, Nasr bridge, Tehran.
City
Tehran
Postal code
111-14115
Phone
+98 21 82880
Fax
Email
Pres@modares.ac.ir
Web page address
http://www.modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares university
Full name of responsible person
Morteza Nazifi
Position
Doctor of psychology
Other areas of specialty/work
Street address
Department of psychology, faculty of humanities, Tarbiat Modares university, Jalal e Al e Ahmad highway, Nasr bridge, Tehran, Iran.
City
Tehran
Postal code
111-14115
Phone
+98 21 82880
Fax
Email
Pres@modares.ac.ir
Web page address
http://www.modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)