Investigating the effect of SCT- based parental behavioral training on improving the behavior of 6-12- year- old children with attention deficit- hyperactivity disorder; A randomized controlled trial
Determining the effect of parent behavioral training on improving the behavior of 6-12 year old children with adhd
Design
A randomized clinical trial with a control and an intervention group, with parallel groups, was conducted on 50 parents. Pass software was used for randomization.
Settings and conduct
Research setting: Imam Reza Clinic, Shiraz
After obtaining the necessary permits, the researcher began to collect samples based on the medical records. First, the informed consent form will be signed by the parents, and in the next stage, information related to the Connors and researcher-made hyperactivity questionnaires will be collected. Parents will be divided into small groups of 8 people. The parent training program will consist of at least 6 60-minute training sessions. One month after the end of the intervention period, the relevant questionnaires will be distributed and collected again for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Age of the child
2- Confirmation of the child's disorder
3- Parental consent to participate in the study
4- Parental literacy
5- No disability of the child
6- Child and parent's lack of participation in similar programs
7- Affected child under the direct care of the parents
8- Time of diagnosis and start of treatment
Exclusion criteria:
1. Withdrawal of the study subjects
2. Failure of the participant to participate in the tests
3. Absence of more than two sessions
Intervention groups
-The intervention group includes parents of children with ADHD who receive a 6-session educational intervention prepared.
-The comparison group includes parents of children with ADHD who receive educational intervention from a doctor according to the clinic routine.
Investigating the effect of SCT- based parental behavioral training on improving the behavior of 6-12- year- old children with attention deficit- hyperactivity disorder; A randomized controlled trial
Public title
Investigating the effect of parental behavioral training on improving the behavior of 6-12 year old children with attention deficit hyperactivity disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The child being studied must be at least 6 years old and no more than 12 years old
The child's attention deficit hyperactivity disorder has been confirmed by the clinic's psychiatrist
The child's parents (at least the mother) must give their consent to participate in the study
The child's parents (at least the mother) must be at least literate (end of third grade of primary school)
The child under study should not have severe physical or motor disabilities or severe hearing or visual impairments
The child and his/her parents (at least the mother) are not participating in an educational program similar to the one that will be implemented in this project
The affected child is under the direct care of the parents (mother, father, or both)
At least 3 months have passed since the child was diagnosed and started treatment
Exclusion criteria:
The child under study has severe physical-motor disabilities or severe hearing and visual impairments.
The child being studied has a specific disease, such as diabetes, that requires special care.
The native language of the child being studied is other than Persian.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the permutation block method to randomly assign participants (parents of hyperactive children) to two control and comparison groups. First, a list of all participants is prepared (50 people). Then, the parents are divided into blocks such that each block contains a certain number of participants. In this study, the size of each block is set to 4 (2 people for the control group and 2 people for the comparison group). NCSS-PASS version 15 software is used to create random sequences. In each block, all possible combinations for assigning participants to two groups (control and comparison) will be listed. One sequence is randomly selected from among the permutation sequences. Participants are assigned to blocks based on the selected random sequence and are assigned to one of the two control and comparison groups.
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 Shiraz University of Medical Sciences
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
-
Approval date
2025-03-04, 1403/12/14
Ethics committee reference number
IR.SUMS.REC.1403.550
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
Children's behavior
Timepoint
Measuring children's behavior once before the start of the study and once one to two months after the intervention.
Method of measurement
Connors Parent Hyperactivity Questionnaire
Secondary outcomes
1
Description
-Knowledge: Learning facts and gaining insight related to an action, idea, object, person, or situation; information and facts about a subject.
Timepoint
Primary outcome measurements once before the start of the study and one to two months after the intervention
Method of measurement
-Researcher-made questionnaire
2
Description
Outcome expectations refer to the value that an individual places on the possible outcomes of performing a behavior.
Timepoint
Primary outcome measurements once before the start of the study and one to two months after the intervention
Method of measurement
-Researcher-made questionnaire
3
Description
Self-efficacy: confidence in one's ability to follow a behavior (confidence in behavior)
Timepoint
Primary outcome measurements once before the start of the study and one to two months after the intervention
Method of measurement
Researcher-made questionnaire
4
Description
Goal setting or self-control: setting goals and planning to carry out chosen behaviors (goal setting)
Timepoint
Primary outcome measurements once before the start of the study and one to two months after the intervention
Method of measurement
-Researcher-made questionnaire
5
Description
Emotional coping: Techniques a person uses to control emotional and physiological states.
Timepoint
Primary outcome measurements once before the start of the study and one to two months after the intervention
Method of measurement
-Researcher-made questionnaire
Intervention groups
1
Description
In the first session: A class for educational intervention will be held at Imam Reza Clinic. Initially, after familiarization, questionnaires will be distributed and collected, and the disease of attention deficit/hyperactivity disorder and the importance of the disease in improving children's behavior will be explained to increase the knowledge structure for 60 minutes using interactive lectures, questions and answers, and PowerPoint educational media and educational clips. In the second session: After reviewing the points of the previous session and announcing the results of the questionnaire, the characteristics and symptoms of the disease, the definition of attention and concentration, the strategy for increasing attention and concentration in order to increase the knowledge structure will be done for 60 minutes using the brainstorming method, interactive lectures, PowerPoint educational media, educational clips, and brochures. In the third session: After reviewing the points of the previous sessions, a description of the principles of behavior change at home and school in order to increase the knowledge structure and improve and change the self-control structure will be done for 60 minutes using interactive lectures, group discussions, PowerPoint educational media, and educational clips. In the fourth session: After reviewing the points of the previous sessions, the treatment of attention deficit/hyperactivity disorder including (drug therapy and behavioral therapy) and the importance of Behavior therapy will be conducted for 60 minutes using interactive lectures and questions and answers, with the help of PowerPoint educational media and educational clips. In the fifth session: After reviewing the points of the previous sessions on the impact of parental behavior and the family system on the treatment process and teaching appropriate behavior between parents and children and the appropriate communication between parents in order to increase the two knowledge structures and self-efficacy, it will be conducted for 60 minutes using interactive lectures and group discussions, with the help of PowerPoint educational media and educational clips. In the sixth session: After reviewing the points of the previous sessions, by defining parenting styles and defining reinforcement patterns (positive reinforcement and negative reinforcement) in order to change the outcome expectation structure for 60 minutes, parents will also be taught the 14 guiding principles for raising children with ADHD in sessions 6 and 7 using interactive lectures and questions and answers, with the help of PowerPoint educational media, educational clips and brochures. In the seventh session: After reviewing the points of the previous sessions, relaxation techniques for parents will be taught for 60 minutes using practical demonstrations and PowerPoint educational media and educational clips. In the eighth session: In this session, by summarizing the material, the success of the program will be examined for 60 minutes using group discussion and PowerPoint media with the aim of resolving problems and answering ambiguities. The educational content has been prepared from reliable sources such as the book Managing the Behavior of Hyperactive Children by Rossella Barclay, which was mentioned in the study. No pharmaceutical, chemical, etc. interventions will be used in this plan.
Category
Behavior
2
Description
Control group: Control group: Initially, after the control group completes the existing questionnaires, this group will proceed according to the educational protocol they receive from the clinic's pediatric psychiatrist. At the end of the intervention, we will provide the control group with the educational content that was taught to the intervention group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic, Shiraz
Full name of responsible person
Dr. Mohammad Hossein Kaveh
Street address
Namazi Street, Imam Reza Clinic, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 901 644 4842
Email
m.mardane_74@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Hamid Mohammadi
Street address
Zand Street, opposite Palestine Street, Shiraz University of Medical Sciences Central Building
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 901 644 4842
Email
m.mardane_74@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
mohadeseh mardaneh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Zand Street, opposite Palestine Street, Shiraz University of Medical Sciences Central Building
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 901 644 4842
Email
m.mardane_74@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Kaveh
Position
full professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Zand Street, opposite Palestine Street, Shiraz University of Medical Sciences Central Building
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 901 644 4842
Email
mhkaveh255@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
mohadeseh mardaneh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Zand Street, opposite Palestine Street, Shiraz University of Medical Sciences Central Building
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 901 644 4842
Email
m.mardane_74@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
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