Determining the effect of family-centered empowerment model on coping strategies of parents of children with cystic fibrosis
Design
Clinical trial with control group
Settings and conduct
The study includes two groups of intervention and control. The intervention group in the family-centered empowerment project will use the family-based empowerment model to examine the impact of the model on parenting coping strategies. This template will be presented in four steps: perceived threat, increased self-efficacy, increased self-esteem and process evaluation, and six educational sessions will be provided for 6 weeks at the Cystic Fibrosis Clinic of the Children's Medical Center. Before the intervention and one month after it is completed, parents will be asked to complete the coping strategies questionnaire. In the control group the training will not be given. The parents of this group are requested to complete the questionnaire two months after completion of the coping strategies.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Passed at least six months from the diagnosis of childhood cystic fibrosis, Having the least literacy of parents to read and write,The child has a medical record in the clinic.
Exclusion criteria:
The child is involved in other chronic illness, in addition to cystic fibrosis, the occurrence of any unexpected incident affecting life from two months before entering the study,Parental involvement in physical and psychological illness.
Intervention groups
In intervention group (one group), family-centered empowerment model in four steps including perceived threat, increasing self-efficacy in child care, increasing self-esteem in child care and process evaluation in six training sessions from 20 to 40 minutes for 6 week will be held. The control group receives the routine training.
Main outcome variables
Coping Strategies score in Lazarus Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180501039489N2
Registration date:2019-01-09, 1397/10/19
Registration timing:prospective
Last update:2019-01-09, 1397/10/19
Update count:0
Registration date
2019-01-09, 1397/10/19
Registrant information
Name
Fahimeh Sabeti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
sabeti.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model (FCEM) on the coping strategies of parents of children with cystic fibrosis
Public title
The effect of family empowerment on the coping strategies of parents of children with cystic fibrosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Passed at Least Six Months of Diagnosis of Childhood Cystic Fibrosis
parents' low literacy
The Child has a Medical Record in the Clinic
Exclusion criteria:
The child is involved in other chronic illness, in addition to cystic fibrosis
The occurrence of any unexpected incident affecting life from two months before entering the study
Parental involvement in physical and psychological illness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-09-03, 1397/06/12
Ethics committee reference number
IR.IUMS.REC.1397.187
Health conditions studied
1
Description of health condition studied
Cystic Fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
Primary outcomes
1
Description
Coping Strategies score in Lazarus Questionnaire
Timepoint
before the intervention and one month after the end of empowerment training
Method of measurement
Lazarus Folkman Coping Strategies Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After completing the coping strategies questionnaire and demographic information, parents of children referred to the cystic fibrosis clinic in the parental intervention group will be included in the family-centered empowerment design using the family-centered empowerment model of Dr. Alhani. This pattern is based on four steps: perceived threats including perceived severity and perceived sensitivity, increased self-efficacy, increased self-esteem and process evaluation, and by holding six training sessions of 20 to 40 minutes on Thursdays at the Cystic Fibrosis clinic of Medical Center will be provided. Meetings will be held in groups of 4 to 6 for parents. One month after the completion of the empowerment plan, parents will be asked to complete the coping strategies questionnaire.
Category
Prevention
2
Description
Control group: Parents referring to the cystic fibrosis clinic of the Children's Medical Center Hospital in the control group will be provided with demographic information and coping strategies. Once completed, parents will routinely take care of their children. Two months after the completion of the questionnaire, Parents will be asked to complete the coping strategies questionnaire.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Cystic Fibrosis Clinic, Children's Medical Center Hospital, Tehran, Iran
Full name of responsible person
Somayeh Kiani
Street address
Children's Medical Center, Qarib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9123
Email
cmc.tums@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malekoti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Sabeti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi Street, Vanak Square, Vali-e Asr Street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
sabeti.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Sabeti
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi Street, Vanak Square, Vali-e Asr Street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 8888 2885
Fax
Email
Sabeti.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Sabeti
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi Street, Vanak Square, Vali-e Asr Street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 8888 2885
Fax
Email
Sabeti.f@iums.ac.ir
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