Effectiveness of Medication and combined Medication and Parent Management Training on Visuo constructive, Attentional, Behavioral and Emotional Indicators of children with Attention Deficit/Hyperactivity Disorder
The aim of the present study was to investigate the effectiveness of Medication and combined Medication and parent Management Training on Visuoconstructive, Attentional, Behavioural and Emotional indicators of children with Attention Deficit/Hyperactivity Disorder. using simple randomized sampling, 18 children 8 to 10 years old with Attention Deficit/Hyperactivity Disorder (Combined type)and IQ above 90 and without pervasive developmental disorder with their mothers were participated in this study. They were inserted into two different groups(9 persons in each group): medication and combined medication and Parent management training. Afterwards subjects were evaluated with child symptom inventory, Bender- Gestalt test, Stroop color –word test and Conner's parent rating scale-revised before and after treatment (which consists of minimum 5 weeks of medication for both groups plus 10 sessions of parent training for combined group).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012712302N1
Registration date:2013-04-15, 1392/01/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-15, 1392/01/26
Registrant information
Name
Zahra Fazeli
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3448 0257
Email address
a-afkham@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-11-20, 1389/08/29
Expected recruitment end date
2011-06-20, 1390/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Medication and combined Medication and Parent Management Training on Visuo constructive, Attentional, Behavioral and Emotional Indicators of children with Attention Deficit/Hyperactivity Disorder
Public title
Effectiveness of Medication and Combined Medication and Parent Management Training on children with Attention Deficit/Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Having diagnostic criteria for Attention Deficit/Hyperactivity Disorder ( combined type )according to DSM-IV-TR diagnostic criteria and diagnoses based on child and adolescent psychiatrist and diagnostic criteria required to fill in a questionnaire CSI and T scores above 65 on Scale D from Conners parent rating scale; Having a calendar age of 8 years (boys and girls who have completed their first year of primary school) to 10 years; Lack of medical and psychological treatment during the 1-month; IQ above 90 on the Raven test and the psychiatrist, content, and overall academic records; Enjoying a high school diploma by parents
Exclusion criteria : Having epilepsy, mental retardation and pervasive developmental disorders according to psychiatrist, case information, education and testing Raven; Impact of brain damage or prematurity
Age
From 8 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
18
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
Tehran University of Medical Sciences
Street address
Keshavarz Bvld, Tehran
City
Tehran
Postal code
Approval date
2011-08-02, 1390/05/11
Ethics committee reference number
729/130/د/90
Health conditions studied
1
Description of health condition studied
Attention Deficit/Hyperactivity disorder
ICD-10 code
F90.8
ICD-10 code description
Other hyperkinetic disorders
Primary outcomes
1
Description
Visuo constructive index
Timepoint
before intervention and after 5th week of interventin
Method of measurement
bender-gestalt test
2
Description
attentional index
Timepoint
before intervention and after 5th week of intervention
Method of measurement
stroop color- word test
3
Description
emotional indicator
Timepoint
before intervention and after 5th week of intervention
Method of measurement
bender- gestalt test
4
Description
behavioral index
Timepoint
before intervention and after 5th week of intervention
Method of measurement
conners test
Secondary outcomes
1
Description
IQ
Timepoint
before intervention
Method of measurement
raven test
Intervention groups
1
Description
group A:medication(MPH)ritalin10mg for 5 weeks
Category
Treatment - Drugs
2
Description
group B: medication as noted plus 10 sessions of parent management training
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Dr Shirazi
Street address
Zafar St, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr Shahrivar
Street address
South Kargar St, Tehran
City
Tehran
3
Recruitment center
Name of recruitment center
Tehran Psychiatric Institute
Full name of responsible person
MS Alimohammadi
Street address
Sattarkhan St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotoohi
Street address
Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Tehran University of Medical Siences
Full name of responsible person
Zahra Fazeli
Position
M.S in clinical psychology
Other areas of specialty/work
Street address
Number 41, Hmze Ali, Aboozar St, Motahati St, Karaj
City
Karaj
Postal code
Phone
+98 26 3448 0257
Fax
Email
zfazeli300@yahoo.comzfazeli300@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Fazeli
Position
M.S in clinical psychology
Other areas of specialty/work
Street address
Number 41, Hmze Ali, Aboozar St, Motahati St, Karaj
City
Karaj
Postal code
Phone
+98 26 3448 0257
Fax
Email
zfazeli300@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical ScienceS
Full name of responsible person
Zahra Fazeli
Position
M.S in clinical psychology
Other areas of specialty/work
Street address
Number 41, Hmze Ali, Aboozar St, Motahati St, Karaj
City
Karaj
Postal code
Phone
+98 26 3448 0257
Fax
Email
zfazeli300@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)