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Comparison of the effectiveness of parent management training sessions through internet based, live, intractive with face-to-face sessions on reducing the symptoms of children with attention deficit hyperactivity disorder.

Protocol summary

Study aim
Determining and comparing the average score of behavior problems, social problems, psychosomatic problems, social phobia, Attention Deficit Disorder (ADD), hyperactivity disorder (HD), attention deficit hyperactivity disorder (ADHD) in two methods of live communication through the Internet and face-to-face through interactive parent management training sessions.
Design
A clinical trial with a control group, with a parallel group, without blinding, randomized, on 92 patients, which is used for randomization using the rand function of Excel software.
Settings and conduct
Randomized clinical trial study method. Parents of children suffering from attention deficit and hyperactivity disorder are receiving drug treatment in Amin and Khurshid Educational Center, Isfahan University of Medical Sciences and Health Services, Department of Psychiatry.
Participants/Inclusion and exclusion criteria
The inclusion criteria included student aged 3 to 12 years referred to Khorshid and Amin Psychiatric Clinic, attentions deficit hyperactivity disorder based on DSM-5, and medication therapy. Exclusion criteria included having any chronic illness, no internet access, and any inability to communicate.
Intervention groups
Intervention group1: This group is comprised of parents who attend online classes. The subject of the course would be PMT (parent management training). The six sessions of this course are held once a week. Intervention group2: This group is comprised of parents who attend face-to-face classes. The subject of the course would be PMT (parent management training). The six sessions of this course are held once a week.
Main outcome variables
Severity of Attention Deficit Hyperactivity Disorder.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211004052670N4
Registration date: 2022-10-24, 1401/08/02
Registration timing: retrospective

Last update: 2022-10-24, 1401/08/02
Update count: 0
Registration date
2022-10-24, 1401/08/02
Registrant information
Name
afsaneh karbasi amel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3641 1255
Email address
afsaneh_karbasi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of parent management training sessions through internet based, live, intractive with face-to-face sessions on reducing the symptoms of children with attention deficit hyperactivity disorder.
Public title
Comparing the effectiveness of face-to-face and online parent management training classes for parents of children with hyperactivity.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Child 3-12 years old Diagnosis of ADHD according to DSM-V
Exclusion criteria:
Intellectual disability or borderline intelligence Concomitant physical disorder Psychological comorbidities Parents' unwillingness to participate in the study
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
The method is premature mature block randomization. In this way, first we using online software (sealedenvelope), a sequence of random numbers will be created and by the same software, the generated number will be divided in to 46 block of 2. Which is an equal number in which block will be 1 item from the intervention group and 1 item from control group. So by doing each block, 1 patien (equal) will be assigned to each group.
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
Research Research Ethics Committees of School of Medicine - Isfahan University of Medical SciencesRe
Street address
Isfahan, Hazar Jarib Street, Isfahan University of Medical Sciences, Building No. 3, Faculty of Medicine, Ground Floor, Department of Medical Ethics
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2022-08-14, 1401/05/23
Ethics committee reference number
IR.MUI.MED.REC.1401.194

Health conditions studied

1

Description of health condition studied
Attention deficit and hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
Severity of Attention Deficit hyper Activity Disorder.
Timepoint
Before the intervention, Immediately after the end of the intervention and tow months after the end of the intervention.
Method of measurement
Using Connors 3rd edition and SNAP-IV questionnaires.

Secondary outcomes

1

Description
Severity of attention deficit hyperactivity disorder.
Timepoint
Two months after the end of the sessions.
Method of measurement
Using Connors 3rd edition and SNAP-IV questionnaires.

2

Description
Severity of attention deficit.
Timepoint
Two months after the end of the sessions.
Method of measurement
Using Connors 3rd edition and SNAP-IV questionnaires.

3

Description
Severity of hyperactivity.
Timepoint
Two months after the end of the sessions.
Method of measurement
Using Connors 3rd edition and SNAP-IV questionnaires.

4

Description
Severity of conduct disorder.
Timepoint
Two months after the end of the sessions.
Method of measurement
Using Connors 3rd edition and SNAP-IV questionnaires.

5

Description
Severity of social problems.
Timepoint
Two months after the end of the sessions.
Method of measurement
Using Connors 3rd edition and SNAP-IV questionnaires.

6

Description
Severity of psychosomatic problems.
Timepoint
Two months after the end of the sessions.
Method of measurement
Using Connors 3rd edition and SNAP-IV questionnaires.

7

Description
Severity of generalized anxiety disorder.
Timepoint
Two months after the end of the sessions.
Method of measurement
Using Connors 3rd edition and SNAP-IV questionnaires.

Intervention groups

1

Description
Intervention group: This group is comprised of parents who attend online classes. The subject of the course would be PMT (parent management training). The six sessions of this course are held once a week. The first session is on children psychology and familiarizing with attention deficit hyperactivity disorder, its etiology, prognosis and treatments. The second session is on commanding. The third one is on strengthening the communication with the child in order to achieve better obedience. The forth and the fifth sessions are about types of encouragement and discipline respectively. The sixth session is on the negative impact of certain situations on child’s misbehavior (e.g., hunger and peer effect). At the beginning of each session, the parents can ask questions about the last sessions and at the end of the session they are guided on specific homework that they are supposed to send to the instructor for review.
Category
Behavior

2

Description
Control group: This group is comprised of parents who attend face-to-face classes. The subject of the course would be PMT (parent management training). The six sessions of this course are held once a week. The first session is on children psychology and familiarizing with attention deficit hyperactivity disorder, its etiology, prognosis and treatments. The second session is on commanding. The third one is on strengthening the communication with the child in order to achieve better obedience. The forth and the fifth sessions are about types of encouragement and discipline respectively. The sixth session is on the negative impact of certain situations on child’s misbehavior (e.g., hunger and peer effect). At the beginning of each session, the parents can ask questions about the last sessions and at the end of the session children’s homework is checked.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin Educational and Therapeutic Center
Full name of responsible person
Afsane Karbassi Amel
Street address
Amin Medical Education Center, Ibn Sina St., Shahada square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Fax
+98 31 3445 9002
Email
amin@mui.ac.ir
Web page address
https://mui.ac.ir/fa/%D9%85%D8%B1%D8%A7%DA%A9%D8%B2-%D8%AF%D8%B1%D9%85%D8%A7%D9%86%DB%8C

2

Recruitment center
Name of recruitment center
Khorshid Medical Educational Research Complex
Full name of responsible person
Afsane Karbasi Amel
Street address
Stendari St. - Khorshid Medical Educational Research Complex ,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81458-33117
Phone
+98 31 3222 2127
Email
merc@edc.mui.ac.ir
Web page address
https://nour.mui.ac.ir/fa/%D8%AF%D8%A7%D9%86%D8%B4%DA%AF%D8%A7%D9%87-%D8%B9%D9%84%D9%88%D9%85-%D9%BE%D8%B2%D8%B4%DA%A9%DB%8C-%D8%A7%D8%B5%D9%81%D9%87%D8%A7%D9%86

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afsane Karbasi Amel
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
https://mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences Research Assistant
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
Esfahan University of Medical Sciences
Full name of responsible person
Afsane Karbassi Amel
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Khorshid Medical Educational Research Complex ,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81458-33117
Phone
+98 31 3222 2127
Email
afsaneh_karbasi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afsane Karbassi Amel
Position
Associat professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Khorshid Medical Educational Research Complex ,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81458-33117
Phone
+98 31 3222 2127
Email
afsaneh_karbasi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ardalan Shokoohifar
Position
Medical science student
Latest degree
A Level or less
Other areas of specialty/work
Psychiatrics
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ardalan.shokohifar@yahoo.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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