Protocol summary

Study aim
Investigating the effectiveness of parent management training on chronic fatigue syndrome and mother-child conflicts in hyperactive children aged 8 to 12 in Sari city
Design
The clinical trial has a control group, 2 parallel groups of 15 people, study type: semi-experimental, sample size of 30 people, not blinded. Rand Excel was used in randomization.
Settings and conduct
The statistical population of the research is all mothers with 8- to 12-year-old boys and girls suffering from attention-deficit/hyperactivity disorder who referred to the Sari Center's Strategy Counseling Center in 2001. Blinding was not done. The study will be conducted as a pre-test and post-test with a control group.
Participants/Inclusion and exclusion criteria
inclusion criteria: absence of mental disorders in mother and child; The age range of the child is 8 to 12 years. exclusion criteria: children with chronic diseases; receiving other treatments at the same time
Intervention groups
From among the statistical population, according to the nature and method of the research, 30 mothers who were willing to participate in the parenting management training sessions were selected according to the access and exit conditions of the study. Then they will be randomly assigned to two experimental and control groups (15 people each). Then, the sample people will receive intervention for eight 90-minute sessions (two sessions per week). After completing the training, the questionnaires will be filled again by the subjects of both groups. The pre-test and post-test scores of the two groups are compared. A summary of the goals and treatment method was mentioned in the intervention.
Main outcome variables
Related: chronic fatigue scores in the Multidimensional Fatigue Measurement Questionnaire (MFI) test and mother-child conflict scores in the Pianta Maternal Quality Test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231126060188N1
Registration date: 2023-12-19, 1402/09/28
Registration timing: registered_while_recruiting

Last update: 2023-12-19, 1402/09/28
Update count: 0
Registration date
2023-12-19, 1402/09/28
Registrant information
Name
Sogand Asghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 410 0626
Email address
sogandasghari2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-24, 1402/03/03
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of parental management training on chronic fatigue syndrome and mother-child conflicts in hyperactive children aged 8 to 12 years in Sari city.
Public title
The effectiveness of parental management training on chronic fatigue syndrome and mother-child conflicts
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of mental disorders in mother and child The age range of the child is 8 to 12 years. The ability to participate in therapy sessions
Exclusion criteria:
Children with chronic diseases Mental retardation, physical disability, use of sleeping pills. Undergoing other special treatments.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
From among the statistical population, according to the nature and method of the research, 30 mothers who were willing to participate in the parenting management training sessions were selected according to the access and exit conditions of the study. Then they were placed randomly in two experimental and control groups (15 people each). After making the necessary arrangements and obtaining the necessary permits, with the coordination and cooperation of the center's psychologist, the day and time of the treatment for the experimental group were determined. Then, by observing the ethical considerations and stating the goals of the research and justifying the research sample, by informing the sample members, among the people who met the conditions and criteria of the research, the sample people will be held for eight sessions for 90 minutes, and two sessions will be held every week. . And assigned to two intervention groups and control group, and before the intervention, the subjects of both groups completed the multi-dimensional fatigue measurement questionnaire and the maternal quality scale questionnaire. Then the intervention group was trained in the parent management program and the control group did not receive any intervention. After completing the training, the questionnaires were filled again by the subjects of both 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
Working group/committee of ethics in research, Islamic Azad University, Semnan branch
Street address
5 km of Semnan road
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.IAU.SEMNAN.REC.1402.051

Health conditions studied

1

Description of health condition studied
The effectiveness of parental management training on chronic fatigue syndrome and mother-child conflicts
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type

Primary outcomes

1

Description
High score in attention deficit hyperactivity disorder questionnaire
Timepoint
Before the beginning of the therapeutic intervention in the first session
Method of measurement
Swanson and Pelham Attention Deficit Hyperactivity Disorder Questionnaire

Secondary outcomes

1

Description
Score in multidimensional fatigue measurement questionnaire (MFI)
Timepoint
After the completion of therapeutic intervention in the eighth session
Method of measurement
Multidimensional Fatigue Measurement Questionnaire (MFI)

2

Description
Score in maternal quality questionnaire
Timepoint
After the completion of therapeutic intervention in the eighth session
Method of measurement
Pianta Maternal Quality Questionnaire

Intervention groups

1

Description
The first intervention group: From among the statistical population, according to the nature and method of the research, 30 mothers who were willing to participate in parenting management training sessions were selected according to the access and exit conditions of the study. Then they are placed randomly in two experimental and control groups (15 people each). After making the necessary arrangements and obtaining the necessary permits, with the coordination and cooperation of the psychologist of the center, the day and time of treatment for the experimental group will be determined. Then, the sample subjects will receive intervention for eight 90-minute sessions (two sessions per week). Both the intervention group and the control group before the start of the intervention, the subjects of both groups completed the multidimensional fatigue measurement questionnaire and the maternal quality scale questionnaire, and then the intervention group will be trained in the parent management program, and the control group will not receive any intervention. After completing the training, the questionnaires will be filled again by the subjects of both groups. A summary of treatment goals and methods: 1st session: changing parents' attitude towards disorder and problematic behavior, assignment of praise and attention technique; The second session: application of rewards and points, the task of completing the positive reinforcement table; The third session: learning the techniques of praise and encouragement, the technique of dedication in strengthening; The fourth session: teaching behavioral management of parents, the task of paying attention and ignoring; The fifth session: improving the child's behavior in school, fines and exclusions; Sixth session: preventing severe misbehavior, reward removal technique; Seventh session: modification of parents' attitude, technique of surrendering what has been learned; Eighth session: review of learned material and how to manage problems in the future, home and school communication assignment
Category
Treatment - Other

2

Description
Control group: The first control group: after selecting the subjects and conducting the necessary investigations to enter the research, it is now time to randomly divide people into two control and intervention groups. The control group will not receive any intervention, but after the intervention, the experimental group will be invited to answer all 2 questionnaires again. The pre-test and post-test scores of the two groups are compared. The number of people in this group will be 15 people.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Strategic Psychology Clinic
Full name of responsible person
Zohreh Asadi
Street address
Strategy Clinic, Unit 25, 3rd Floor, Tous Doctors Building, Qaran St., Sari
City
Sari
Province
Mazandaran
Postal code
4818917371
Phone
+98 11 3332 4724
Email
sogandasghari2@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Karim Sohrabi
Street address
Semnan, km 5 of Damghan road, in front of Semnan customs
City
Semnan
Province
Semnan
Postal code
3711135131
Phone
+98 23 3165 6565
Email
info@semnaniau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
sogandasghari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Avesta Apartment, Nasohi Alley, Salman Farsi St., Taleqani Blvd., Sari
City
Sari
Province
Mazandaran
Postal code
3711135131
Phone
+98 11 3320 9593
Email
sogandasghari2@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sogand Asghari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Avesta Apartment, Nasohi Alley, Salman Farsi St., Taleqani Blvd., Sari
City
Sari
Province
Semnan
Postal code
4818917371
Phone
+98 11 3320 9593
Email
sogandasghari2@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
sogandasghari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Avesta Apartment, Nasohi Alley, Salman Farsi St., Taleqani Blvd., Sari
City
Sari
Province
Mazandaran
Postal code
4818917371
Phone
+98 11 3320 9593
Email
sogandasghari2@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
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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