Determining The Effect of Group Discussion on Parental-Child Conflict in Mothers with Children Hospitalized in Psychiatric Wards
Design
This will be a phase 3 clinical trial study with a control group, with parallel group design, randomized and with a sample size of 70 people. Samples will be randomly divided into two experimental and control groups. We will use random sequence generation software.
Settings and conduct
The location of the study will be the psychiatry department of Noor and Ali Asghar Hospital of Isfahan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers with at least one child with one of the types of psychiatric disorders and psychiatric hospitalization; length of stay in the ward for at least one week; age of at least 18 years; definitive diagnosis of the disease.
Non-inclusion criteria: Unwillingness to be in the study and group sessions
Intervention groups
Intervention group: According to the research plan, treatment group discussion sessions for the intervention group will be conducted in eight 90-minute sessions. Groups will be selected according to the time and date of the event and the number of participants in each group will range from at least six to a maximum of ten.
control group: The control group received no intervention.
Main outcome variables
Patient-child conflict
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191229045926N1
Registration date:2020-01-31, 1398/11/11
Registration timing:registered_while_recruiting
Last update:2020-01-31, 1398/11/11
Update count:0
Registration date
2020-01-31, 1398/11/11
Registrant information
Name
Zahra Ataei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4001
Email address
zahra.ataei@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-19, 1398/10/29
Expected recruitment end date
2020-07-19, 1399/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Discussion on Parental-Child Conflict in Mothers with Children Hospitalized in Psychiatric Wards
Public title
Effect of Group Discussion on Parental-Child Conflict in Mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with at least one child with one of the types of psychiatric disorders and psychiatric hospitalization
The patient's length of stay in the ward lasts at least one week
The definitive diagnosis of the disease has been determined.
Exclusion criteria:
Unwillingness to be in the study and group sessions
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
We will randomly assign the samples to two experimental and control groups. We will use random sequence generation software.
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 Islamic Azad University, Isfahan (Khorasgan) branch
Street address
Daneshgah blvd., Arghavanieh blvd., East Jey street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Approval date
2019-12-01, 1398/09/10
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.217
Health conditions studied
1
Description of health condition studied
Parental-Child Conflict
ICD-10 code
Z62.82
ICD-10 code description
Parent-child conflict
Primary outcomes
1
Description
Parental-Child Conflict
Timepoint
Before the intervention and after the intervention
Method of measurement
The data gathering tool in this study is the Child Parent Conflict Questionnaire (CTSPC).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Recipient of group discussion therapy sessions - According to the research plan, treatment sessions for the experimental group will be conducted in eight 90-minute sessions. Groups will be selected according to the time and date of the event and the number of participants in each group will range from at least six to a maximum of ten. Group discussions will be held in 90-minute sessions and two sessions per week for mothers. The program and content intended for the sessions will be implemented as follows: Session One: Purpose is to Introduce members, introduce group rules, and familiarize yourself with the characteristics of adolescence and mother-child relationships. Session 2: The goal is to get feedback from the previous session, to review the assignment, to educate mothers to correct irrational beliefs in parenting. Session 3: Educating mothers to increase self-efficacy in conflict resolution. Session 4: Teaching mothers how to increase self-control during conflicts. Session 5: Teaching mothers how to increase anger control during conflicts. Session 6: Educating Mothers to Increase Self-Esteem in Conflict Resolution. Session 7: Educate mothers to increase decision making skills in conflict resolution. Session 8: Educate mothers on techniques to encourage behaviors.
Category
Treatment - Other
2
Description
Control group: No intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor and Ali Asghar Hospital (Khorshid hospital) in Isfahan
Full name of responsible person
Ramin Sami
Street address
Ostandari Street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 2222 2127
Email
raminsami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toghiani
Street address
Islamic Azad University, Isfahan (Khorasgan) branch, Daneshgah blvd., Arghavanieh blvd., East Jey street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3535 4001
Email
toghiani@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Zahra Ataei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) branch, Daneshgah blvd., Arghavanieh blvd., East Jey street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3535 4001
Email
zahra.ataei@khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Ataei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) branch, Daneshgah blvd., Arghavanieh blvd., East Jey street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3535 4001
Email
zahra.ataei@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Ataei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) branch, Daneshgah blvd., Arghavanieh blvd., East Jey street
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱۳۹۹۹۸
Phone
+98 31 3535 4001
Email
zahra.ataei@khuisf.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Data will be available only to researchers working in academic and research institutions
Under which criteria data/document could be used
The data can only be used for future research
From where data/document is obtainable
Refer to Research Deputy of Islamic Azad University, Isfahan (Khorasgan) branch
What processes are involved for a request to access data/document
The data will be available after the administrative procedure set by the research Deputy.