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Tailoring the Positive Parenting Program Based on ADHD Parent's lived Experience and Evaluation of the Effects on Parent’s Competence and Child’s Behavioral Problems

Protocol summary

Study aim
1- Tailoring a positive parenting program for the families of Iranian children with attention deficit-hyperactivity disorder 2- Evaluating the effect of the designed intervention on parents' competence and reducing the behavioral problems of children with attention deficit-hyperactivity disorder
Design
This clinical trial has an intervention group consisting of 5 parents (parents with a child with Attention Deficit Hyperactivity Disorder) who are selected from the purposeful and available sampling method.
Settings and conduct
Due to the conditions of the corona epidemic, each intervention session will be held online for one hour.
Participants/Inclusion and exclusion criteria
Criteria for entering the research 1- Written consent of the child's parents for informed and committed participation in the research 2- Having a child 6-12 years old with attention deficit-hyperactivity disorder 3- Parents complain about the child's behavioral problems 4- Absence of parents in similar programs 5- Simultaneous presence of parents
Intervention groups
The intervention includes 8-10 psychological sessions of Positive Parenting Program (Triple P). In each session, parents are taught how to properly treat children with attention deficit hyperactivity disorder.
Main outcome variables
Tailoring a positive parenting program for families of Iranian children with Attention Deficit Hyperactivity Disorder; Teaching parents how to behave properly towards children with Attention Deficit Hyperactivity Disorder; Increasing the competence of parents with a child with Attention Deficit Hyperactivity Disorder; Reducing Behavioral Problems in Children with Attention Deficit Hyperactivity Disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200909048669N1
Registration date: 2021-08-20, 1400/05/29
Registration timing: prospective

Last update: 2021-08-20, 1400/05/29
Update count: 0
Registration date
2021-08-20, 1400/05/29
Registrant information
Name
shokouh Eftari
Name of organization / entity
The university of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 21 3334 6846
Email address
std_shokouh.eftari@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tailoring the Positive Parenting Program Based on ADHD Parent's lived Experience and Evaluation of the Effects on Parent’s Competence and Child’s Behavioral Problems
Public title
effect of parenting on ADHD Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
have a 6-12 years old child with ADHD disorder
Exclusion criteria:
have no 6-12 years old child with ADHD disorder
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 5
More than 1 sample in each individual
Number of samples in each individual: 2
Father and mother
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of kharazmi university
Street address
No. 5, Unit 5, Mofrahnejad Alley, Shoofeh St., Shoofeh St., Piroozi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1717946956
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.KHU.REC.1400.001

Health conditions studied

1

Description of health condition studied
Attention-deficit/hyperactivity disorder (ADHD)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Child Symptom Inventory-4 (CSI4) score; Parenting Sense of Competence score
Timepoint
4 times before the intervention at intervals of one week, and 4 times during the intervention at intervals of one week, and 4 times after the intervention at intervals of one week
Method of measurement
Child Symptom Inventory-4 (CSI4); Parenting Sense of Competence

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Parents of 6-12 year old with Attention Deficit Hyperactivity Disorder
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasesh Psychological Counseling and Services Center
Full name of responsible person
Sedighe Ahmadi
Street address
Tehran. Fatemi St., No. 221
City
Tehran
Province
Tehran
Postal code
1400000000
Phone
+98 21 8897 0494
Email
Dr.ahmadi.sedighe@khu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Dr. sedighe Ahmadi
Street address
No. 43, Shahid Mofteh St., Tehran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8832 9220
Email
Std_shokouh.eftari@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kharazmi
Proportion provided by this source
1
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
The University of Kharazmi
Full name of responsible person
Shokouh Eftari
Position
student
Latest degree
Master
Other areas of specialty/work
Counseling
Street address
No. 4, Mofrahnejad Alley, Noursalehi St., Shokoخfeh St., Piroozi St., Tehran
City
Tehran
Province
Tehran
Postal code
1717946956
Phone
+98 21 3334 6846
Email
shokouh.eftari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Sedighe Ahmadi
Position
Assistant professer
Latest degree
Ph.D.
Other areas of specialty/work
Counseling
Street address
No. 43, Shahid Mofateh Street, Tehran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8832 9220
Email
Dr.ahmadi.sedighe@khu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Shokouh Eftari
Position
student
Latest degree
Master
Other areas of specialty/work
Counseling
Street address
No. 4, Mofrahnejad Alley, Noursalehi St., Shokoخfeh St., Piroozi St., Tehran
City
Tehran
Province
Tehran
Postal code
1717946956
Phone
+98 21 3334 6846
Email
Std_shokouh.eftari@khu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the names of the individuals are not identified, the results of the clinical trial can be shared.
When the data will become available and for how long
Access period starts from 2022
To whom data/document is available
Researchers and therapists in the field of children
Under which criteria data/document could be used
There are no restrictive conditions.
From where data/document is obtainable
shokouh.eftari@gmail.com
What processes are involved for a request to access data/document
One week from the time of sending the request
Comments
The results of this clinical trial will be made available to others in the form of a scientific research article.
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