Protocol summary

Study aim
Determining the effect of caring behaviors education by Role-Play Simulation on resilience and psychological well-being of mothers with child with attention deficit/hyperactivity disorder
Design
This study is of the field trial type and has a control group and a sample of 60 people who are divided into two intervention and control groups based on the allocation of random blocks, and there is a blind strain.
Settings and conduct
In this study, mothers with child with attention-deficit/hyperactivity disorder referring to psychiatry and psychology centers in Yasuj city, and place of the intervention will be Mofateh clinc and a blind study will be conducted for the participants.
Participants/Inclusion and exclusion criteria
Entry requirements for participants 1) Consent to participate in the study and sign the informed consent form by the child's mother 2) The age range of these mothers' children is between 6-12 years old (school age). 3) The child has both types of attention deficit and hyperactivity disorder. Conditions of non-entry of participants 1) lack of informed consent of the mother to participate in the study 2) The child has only one of the disorders of attention deficit and hyperactivity. 3) History of the mother's participation in similar training courses in the last six months 4) receiving other psychological treatment at the same time as this mother's intervention
Intervention groups
In the intervention group, a preliminary session and two scenario sessions (one for attention deficit and one for hyperactivity) and a final evaluation session will be conducted. And in total, the intervention will be done in 4 sessions of 60 minutes for 4 weeks. And the control group will not receive any intervention.
Main outcome variables
Helping to improve resilience and psychological well-being of mothers with child with attention deficit/hyperactivity disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240618062165N1
Registration date: 2024-07-08, 1403/04/18
Registration timing: registered_while_recruiting

Last update: 2024-07-08, 1403/04/18
Update count: 0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Arman Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 8495
Email address
armandehghani50@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2024-10-31, 1403/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of caring behaviors education by Role-Play Simulation on resilience and psychological well-being of mothers with child with attention deficit/hyperactivity disorder
Public title
the effect of caring behaviors education by Role-Play Simulation on resilience and psychological well-being of mothers with child with attention deficit/hyperactivity disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of attention deficit/hyperactivity disorder by a psychiatrist Consent to participate in the study and sign the informed consent form by the child's mother The age range of these mothers' children is between 6-12 years old (school age). The child has both types of attention deficit and hyperactivity disorder.
Exclusion criteria:
Mother suffering from acute and chronic physical and cognitive problems Lack of informed consent of the mother to participate in the study The child has only one of the disorders of attention deficit and hyperactivity. The history of the mother's participation in similar training courses in the last six months Receiving other psychological treatment at the same time as this mother's intervention Failure to meet the study entry criteria
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be selected through available sampling and will be assigned to one of two intervention and control groups through random block allocation. In this way, first by multiplying the number of studied groups (two groups) by 2, the number of samples of each block is calculated equal to 4, then by factorial calculation(24=1×2×3×4=!4), the number Blocks resulting from all modes of arrangement of people, 24 blocks are calculated, then, since the number of people in each block is 4, there will be 4 participants in each block (2 participants from each group) whose arrangement is different. . Therefore, the blocks will be randomly selected by placement, with the selection of each block, there will be 4 participants, and the allocation method is also known. ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, BACD, BADC, BCAD, BCDA, BDAC, BDCA, CABD, CADB, CBAD, CBDA, CDAB, CDBA, DABC, DACB, DBAC, DBCA, DCAB, DCBA Group labeling have been determined randomly and by lottery that A=intervention, B=control, C=control and D=intervention. They will be assigned a code, and by matching that number with the random block allocation list, the patients participating in the research will be assigned to one of the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the participants are unaware of the study group allocation. If the researchers and outcome assessors are aware of the allocation of the study groups and carefully monitor the participants in terms of blinding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
ethics committee, University of Medical Sciences, Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.YUMS.REC.1403.034

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
Connor-Davidson resilience scale score
Timepoint
Measuring Resilience at the beginning of the study and at the end of the study and 30 days after the end of the study
Method of measurement
Connor-Davidson resilience scale

Secondary outcomes

1

Description
Riff psychological well-being scale score
Timepoint
Measuring psychological well-being at the beginning of the study and at the end of the study and 90 days after the end of the study
Method of measurement
Riff psychological well-being scale

Intervention groups

1

Description
Intervention group: In the intervention group, mothers with children with attention deficit/hyperactivity disorder are taught two role-playing simulation scenarios related to caring behaviors regarding attention deficit hyperactivity disorder. that the study scales will be completed by the participants before and after the end of the study. And a total of 4 60-minute intervention sessions, one introductory explanation session, two scenario implementation sessions, and one final summary session will be conducted.
Category
Behavior

2

Description
Control group: No intervention will be done for the control group and after the end of the study scenarios and care training will be provided to them.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofateh clinic 3
Full name of responsible person
Hafez Mohammad Hosseinpour
Street address
upper floor of Dr. Rastgo Pharmacy, Golestan 10, Pasdaran Blvd
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591777946
Phone
+98 917 419 9134
Email
hafez90mhp@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Research assistant, University of Medical Sciences, Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Zohreh Karimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3323 5138
Email
karimiz48@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zohreh Karimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3323 5138
Email
karimiz48@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Arman Dehghani
Position
Master of Science student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Reza Dormitory, Chamran Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591777946
Phone
+98 74 3322 8495
Fax
Email
armandehghani50@gmail.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
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