The Effectiveness of the Empowerment Program on the Life Quality of Families of Children with Mental Disorders
Design
This study is a non-blinded randomized clinical trial with a parallel control group and examines 40 patients. The subjects will be selected by convenience sampling, and colored cards will be used for random allocation. The empowerment program will be implemented for the intervention group.
Settings and conduct
Mentally disordered children’s families referring to health centers of Isfahan and possessing the inclusion criteria will be assigned to the experimental and control groups. Both groups will complete the empowerment questionnaire before the intervention. The role modeling method and face-to-face training will be utilized to implement the family empowerment program for the intervention group, and the mentioned questionnaire will be refilled immediately and three months after the intervention. The patient-based empowerment intervention will also be provided to the control group
Participants/Inclusion and exclusion criteria
Inclusion criteria: Families of children with medically-diagnosed mental disorders
Exclusion criteria: Children suffering from any mental disorders caused by mental retardation or any severe treatment-preventing medical illnesses
Intervention groups
The intervention group will receive the package designed for family empowerment. It is worth mentioning that the exact content of the program will be determined after interviews with key individuals (families of children with mental disorders and relevant stakeholders in this domain). In the control group, patient-based empowerment will be implemented.
Main outcome variables
Empowerment; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191225045893N1
Registration date:2023-12-24, 1402/10/03
Registration timing:prospective
Last update:2023-12-24, 1402/10/03
Update count:0
Registration date
2023-12-24, 1402/10/03
Registrant information
Name
Saedeh Zeynalzad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6681 3969
Email address
saedehzeynalzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of family empowerment programs of children with mental disorders
Public title
Effectiveness of family empowerment programs of children with mental disorders
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
children 's families with medical diagnosis of mental disorder
Exclusion criteria:
Mental disorder in children is not a result of mental retardation
Having any type of severe medical illness that prevents the continuation of treatment
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of families to intervention and control groups will be done using closed envelopes containing red and blue cards. The families referring to the medical centers will choose one of the envelopes and accordingly they will be placed in one of the two control and intervention groups and will receive the intervention related to the same group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Nursing-Management and Rehabilitation, Isfahan University of
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.181
Health conditions studied
1
Description of health condition studied
family with mental disorder
ICD-10 code
F90-F98
ICD-10 code description
V Mental and behavioral disorders
Primary outcomes
1
Description
empowerment
Timepoint
0-3 months after intervention
Method of measurement
Questionnaire dimensions of empowerment
Secondary outcomes
1
Description
quality of life
Timepoint
0-3 months after the intervention
Method of measurement
Quality of life questionnaire
Intervention groups
1
Description
Intervention group: The family-based empowerment intervention will be conducted in the form of weekly meetings, through face-to-face training and role-playing model for the families of the intervention group, based on the program compiled from the previous stages. Before, immediately after the intervention and 3 months later, the empowerment questionnaire is filled and the scores are compared.
Category
Behavior
2
Description
Control group: Patient-based empowerment intervention will be taught for the control group to compare with the intervention group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Mahrokh keshvari
Street address
university of medical sciences and health services in isfahan province
City
ESfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7569
Email
keshvari@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
university of medical sciences and health services in isfahan province
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7569
Email
keshvari@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
20
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
Esfahan University of Medical Sciences
Full name of responsible person
Mahrokh keshvari
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
ESfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7569
Email
keshvari@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
saedeh zeynalzad
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences
City
ESfahan
Province
Isfehan
Postal code
8174673461
Phone
36687153-31
Email
saedehzeynalzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
saedeh zeynalzad
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
36687153-31
Email
saedehzeynalzadeh@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