Comparing the effect of family management training (PMT) and attention process training (APT) in children with attention deficit and ADHD disorder under drug treatment
Comparing the effect of family management treatment (PMT) and attention process therapy (APT) in Children with hyperactivity disorder and attention deficit
Design
In this interventional study, 45 patient with ADHD will be selected and divided into three groups using block randomization method (n=15 each group). Proper counseling will be done and a written informed consent will be obtained before starting the treatment regimen.
Settings and conduct
In this study children with ADHD who will be referred to the psychiatric clinic of Fatemi Hospital in Ardabil will be investigated. At the beginning of the study, all patients will be evaluated in terms of degree of ADHD. After the end of treatment scores of the last assessment will be considered as a post-test scores and results will be compared.During the study participants and data analyser will be not aware of the type of medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ADHD, no drug intake. Exclusion criteria: Presence of mental illness, failure to cooperate due to hearing impairment, visual acuity, and movement, psychosis in the child and mother، Absence for maximum two sessions.
Intervention groups
Intervention group 1: In this group parents of subjects will be received parenting management training (PMT) treatment beside drug therapy. Intervention group 2: In this group, the child with ADHD will be trained by a psychologist with attention process training technique (APT) beside drug therapy. Intervention group 3: patients will be received only drug therapy same as other groups.
Main outcome variables
Decreased ADHD symptom
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171104037215N2
Registration date:2018-06-08, 1397/03/18
Registration timing:prospective
Last update:2018-06-08, 1397/03/18
Update count:0
Registration date
2018-06-08, 1397/03/18
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 6616
Email address
p.bakhshi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of family management training (PMT) and attention process training (APT) in children with attention deficit and ADHD disorder under drug treatment
Public title
Effect of family management training (PMT) with attention process training (APT) in ADHD children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having ADHD disorder
No drug intake
Exclusion criteria:
Absence for maximum two sessions
The presence of mental illness, depression, psychosis in the child and mother
Failure to cooperate due to hearing impairment, visual acuity, and movement
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
15
Everyone is in the sample as a person and has an equal likelihood of selection
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned randomly by blocking in one of the three specified groups and after selecting the envelope for each patient, before starting the treatment regimen envelope will be opened and based on the protocol, one of three methods will be selected.
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 Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5615783134
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.ARUMS.REC.1396.108
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
concentration
Timepoint
Before beginning of intervention and three times (end of first, second and third months) after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Hyper Active disorder
Timepoint
Before beginning of intervention and three times (end of first, second and third months) after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: In this group parents of subjects will be received parenting management training (PMT) treatment and Ritalin 10 mg, three times a day (Exir Co).
Category
Behavior
2
Description
Intervention group: The child with ADHD will be trained by a psychologist with attention process training technique (APT) and Ritalin 10 mg, three times a day (Exir Co).
Category
Behavior
3
Description
Control group: patients will be received Ritalin 10 mg, three times a day (Exir Co)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital
Full name of responsible person
Mehriar Nadrmohamadi
Street address
Fatemi Hospital, Shariati Square, Ardabi
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
M.nadermohammadi@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahab Bohlooli
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 3352 2247
Email
Shahab.bohlooli@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Mehriar Nadrmohamadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Fatemi Hospital, Shariati Square, Ardabi
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
M.nadermohammadi@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehriar Nadrmohamadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Fatemi Hospital, Shariati Square, Ardabi
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
M.nadermohammadi@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehriar Nadrmohamadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Fatemi Hospital, Shariati Square, Ardabi
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
M.nadermohammadi@arums.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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available