Protocol summary

Study aim
Determining the effectiveness of clinical guidelines on the behavior management of children with attention deficit hyperactivity disorder
Design
The clinical trial will have a control group, with parallel groups, sampling with non-probability sequential method. The samples will be randomly divided into two test groups (N=29) and control group (N=29) using the randomized permutation method.
Settings and conduct
Place of study: Golestan Hospital is affiliated to Ahvaz University of Medical Sciences. Study population: 58 parents have a child with attention deficit hyperactivity disorder. Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Registration and certainty of the diagnosis of attention deficit hyperactivity disorder in the child's medical record 2. These children should not suffer from any other psychological disorders 3. They have not received the drugs related to this disorder in the time interval between the diagnosis of the disorder and the beginning of the training sessions. 4. Parents have not participated in educational groups before. 5. Parents must have the mental and intellectual ability to complete the questionnaire and participate in the educational program. Exclusion criteria: Absence of more than one session in training sessions
Intervention groups
Intervention group: combined educational intervention (face-to-face, presentation of educational pamphlets) will be provided by the researcher during six 40-minute sessions to familiarize parents with clinical guidelines. The control group will not receive any training in this field during the research.
Main outcome variables
Behavior management of children with attention deficit disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240525061891N1
Registration date: 2024-06-16, 1403/03/27
Registration timing: prospective

Last update: 2024-06-16, 1403/03/27
Update count: 0
Registration date
2024-06-16, 1403/03/27
Registrant information
Name
Leila Ghotbian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3372 5857
Email address
ghotbian.l@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of clinical guideline on the behavior management of the children with attention-deficit/hyperactivity disorder
Public title
The effect of clinical guideline on the behavior of hyperactive children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Registration and certainty of the diagnosis of attention deficit hyperactivity disorder in the child's medical record Absence of other psychological disorders They have not received the drugs related to this disorder in the time interval between the diagnosis of the disorder and the beginning of the training sessions Parents have not participated in educational groups before. Parents must have the mental and intellectual ability to complete the questionnaire and participate in the educational program.
Exclusion criteria:
Suffering from other psychological disorders Taking drugs related to attention deficit and hyperactivity disorder during the study period
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: 58
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples are selected from among the research population based on the entry and exit criteria, and then randomly assigned to two test and control groups using the block method. 14 blocks are formed and the samples are randomly assigned to one of the test and control groups through blocks of 4. Symbol A is assigned to the test group and symbol B is assigned to the control group. List of states of groups in 6 preparation states and numbers 1 to 6 are assigned to them. AABB BBAA ABAB BABA ABBA BAAB Then the numbers 1 to 6 are chosen randomly (lottery/person outside the study) and the list of allocation of participants is specified according to the selected number to the test group (A) and control group (B) and sampling is done based on the list. Sampling is done in the control and test groups at the same time.
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 Jundi Shapur Ahvaz University of Medical Sciences
Street address
Ahvaz university of medical sciences, Esfand Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.AJUMS.REC.1403.052

Health conditions studied

1

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

Primary outcomes

1

Description
Behavior of children with attention deficit hyperactivity disorder
Timepoint
Before the start of the intervention and two months after the end of the intervention.
Method of measurement
Conners’s questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in the test group for parent education, combined training sessions (face to face and presentation of pamphlets) about attention deficit hyperactivity disorder, behavioral management measures and its treatment, by the researcher during 6 sessions of 40 minutes (one session per week) ) will be executed. Also in At the end of the sessions, educational pamphlets will be provided to parents.
Category
Behavior

2

Description
Control group: No educational intervention will be done in the control group; But in order to comply with ethical considerations, after analyzing the results, the educational pamphlet will be delivered to the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Ashrafalsadat Hakim
Street address
Golestan hospital, Farvardin Ave., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3374 3001
Email
golestanhospital@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehrnoosh Zakerkish
Street address
Ahvaz university of medical sciences, Esfand Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2392
Email
hakim3448200@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Assistant professor, faculty member
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Ahvaz university of medical sciences, Esfand Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2392
Email
hakim3448200@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Assistant professor, faculty member
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Ahvaz university of medical sciences, Esfand Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2392
Email
hakim3448200@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Assistant professor, faculty member
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Ahvaz university of medical sciences, Esfand Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2392
Email
Hakim3448200@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
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
Loading...