Protocol summary

Summary
Attention deficit hyperactivity disorder (ADHD) is a known disorder in which children have an attention deficit and hyperactivity. This disorder may interfere in executive function like memory that is necessary for people’s action. In this interventional study we are going to know if psychotherapy and behavioral treatment beside routine pharmacotherapy has an efficacy on working memory of children with ADHD. For finding the answer we will recruit 40 (20 male and 20 female) and divide them to two groups randomly (one group will take Pharmacotherapy without psychotherapy and the other pharmacotherapy plus psychotherapy). The results of pre and post test will be compared according to the aims of study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812123480N1
Registration date: 2010-11-29, 1389/09/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-11-29, 1389/09/08
Registrant information
Name
Mohammad Ahmadpanah
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1828 5015
Email address
ahmadpanah@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and technology deputy of Hamadan University of Medical Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of psychotherapy and pharmacotherapy on working memory of children with Attention deficit and hyperactivity disorder
Public title
Efficacy of psychotherapy and pharmacotherapy on working memory of children with Attention deficit and hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: 1- having the criteria of Attention deficit and hyperactivity disorder according to DSM-TR. 2-not having the other psychological disorders. 3- Being in normal range of intelligence. Exclusion criteria: participation in lower than 95% of intervention sessions.
Age
No age limit
Gender
empty
Phase
empty
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Dr Ali GHaleiha
Street address
Research and technology deputy of Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
2010-11-08, 1389/08/17
Ethics committee reference number
پ/16/35/9/89381

Health conditions studied

1

Description of health condition studied
working memory in attention deficit and hyperactivity disorder children
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
working memory
Timepoint
6 months
Method of measurement
memory tests

Secondary outcomes

empty

Intervention groups

1

Description
Control group: routine pharmacotherapy
Category
Treatment - Drugs

2

Description
Intervention group: routine pharmacotherapy plus psychotherapy
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
psychiatrists offices
Full name of responsible person
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and technology deputy of Hamadan University of Medical Sciences
Full name of responsible person
Dr Ghaleiha
Street address
Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and technology deputy of Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Ahmadpanah
Position
Assistant Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 1828 5015
Fax
Email
m1_ahmad2000@yahoo.com , ahmadpanah@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad AhmadPanah
Position
Ph.D
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 1828 5015
Fax
Email
ahmadpanah@umsha.ac.ir , m1_ahmad2000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Reserch center For Behavioral Sciences
Full name of responsible person
Mohammad Ahmadpanah
Position
Ph.D
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 1828 5015
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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