Determining the Effect of Resilience Training on Coping Strategies and Well-being of Mothers of Children with Down Syndrome
Design
A randomized, single-blind, parallel-group, controlled clinical trial without run-in phase conducted on 100 patients. Randomization was performed using a random number table.
Settings and conduct
The study is being conducted at the Down Syndrome Association of Kerman, where eligible mothers are selected through census sampling. The intervention consists of resilience training provided in nine 60-minute sessions (one session per week for two months) to mothers of children with Down syndrome. Responses are collected using the Coping Strategies Questionnaire and the WHO Well-Being Index before and after the intervention.
Participants/Inclusion and exclusion criteria
Mother and child living together؛ Unwillingness to continue participation
Intervention groups
The intervention group received 60-minute weekly resilience training for 2 months. Both groups completed coping/well-being questionnaires pre-, post-, and 1-month post-intervention. Controls received no training.
Main outcome variables
Clinical: This study aims to enhance coping strategies and well-being of mothers of children with Down syndrome through resilience training interventions.Education: Findings may guide nurse training programs to better support these mothers' resilience and mental health.Research: Results could inform future intervention studies in this field.Management: May improve support systems and care management for affected families.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250114064382N1
Registration date:2025-05-10, 1404/02/20
Registration timing:prospective
Last update:2025-05-10, 1404/02/20
Update count:0
Registration date
2025-05-10, 1404/02/20
Registrant information
Name
Fatemeh Akhlaghi fath abad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3323 7323
Email address
f.akhlaghi80@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-07-12, 1404/04/21
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Resilience Training on The Coping Strategies and Well-Being of Mothers of Children With Down Syndrome
Public title
The Effect of Resilience Training on The Coping Strategies and Well-Being of Mothers of Children With Down Syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The child and mother living together.
No history of psychiatric disorders or severe incidents leading to physical/psychological injuries among participating mothers.
Absence of serious emotional difficulties or severe family crises (e.g., divorce, death of first-degree relatives, etc.).
Minimum education level: elementary school.
Mothers participating in the study must not have undergone any similar psychological intervention programs prior to attending the resilience training sessions.
Exclusion criteria:
Unwillingness to participate in the research study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be selected via census sampling. After meeting the inclusion criteria and having no exclusion criteria, they will be assigned to either the intervention or control group using a random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
To comply with the blinding principle, the data were labeled with random codes (A and B). Statistical analyses were performed without the analyst's knowledge of the groups' identities (intervention/control), and the code key was only revealed after the completion of the analyses.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Jahad Blvd, Ebn Sina Avenue, Somayeh Crossroads, Kerman
City
Kerman
Province
Kerman
Postal code
7613859610
Approval date
2025-05-03, 1404/02/13
Ethics committee reference number
IR.KMU.REC.1404.028
Health conditions studied
1
Description of health condition studied
Down Syndrome
ICD-10 code
Q90.2
ICD-10 code description
Trisomy 21, translocation
Primary outcomes
1
Description
Coping Strategies
Timepoint
At study initiation, immediately following study completion, and one month after study completion
Method of measurement
Billings & Moos Coping Strategies Checklist
2
Description
Well-being
Timepoint
At study initiation, immediately following study completion, and one month after study completion
Method of measurement
Five-item World Health Organization Well-being Index
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, resilience training is implemented for mothers of children aged 8–14 with Down syndrome at the Down Syndrome Association. The training consists of nine 60-minute sessions, held once a week over two months. The Billings & Moos Coping Strategies Checklist and the Five-item World Health Organization Well-being Index (WHO-5) questionnaires are completed by the mothers before the intervention, immediately after the intervention, and one month after the intervention ends.
Category
Other
2
Description
Control group: In the control group, mothers completed the Billings & Moos Coping Strategies Checklist and the Five-item World Health Organization Well-being Index (WHO-5) at three time points: before the intervention period, immediately after the intervention period (2 months), and one month following the intervention period.To prevent cross-contamination between groups, participants from both groups only interacted during the initial introductory session. The control group did not receive any resilience training during the study period. However, to maintain ethical standards and prevent feelings of disadvantage, a condensed 60-minute summary of the resilience training materials was provided to control group participants upon study completion.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Province Down Syndrome Association
Full name of responsible person
Azadeh Salehi Kermani
Street address
Seh Rah-e Dokhaniyat, next to Habib Ibn Mazahir Mosque
City
Kerman
Province
Kerman
Postal code
7635111111
Phone
+98 913 342 8040
Email
azadeh.salehi.kermani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malek Por Afshar
Street address
Building No. 3, Ibn Sina St., University of Medical Sciences Campus,, Haft Bagh Alavi Square, Danesh Blvd., Kerman Town.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5638
Email
malekpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Akhlaghi fath abad
Position
Student
Latest degree
Master
Other areas of specialty/work
pediatric nursing
Street address
No1.emam reza blvd.kerman town
City
Kerman
Province
Kerman
Postal code
7635148717
Phone
+98 34 3323 7323
Fax
Email
F.akhlaghi80@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Akhlaghi fath abad
Position
Student
Latest degree
Master
Other areas of specialty/work
pediatric nursing
Street address
No1.emam reza blvd.kerman town
City
Kerman
Province
Kerman
Postal code
7635148717
Phone
+98 34 3323 7323
Fax
Email
F.akhlaghi80@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Akhlaghi fath abad
Position
Student
Latest degree
Master
Other areas of specialty/work
pediatric nursing
Street address
No1.emam reza blvd.kerman town
City
Kerman
Province
Kerman
Postal code
7635148717
Phone
+98 34 3323 7323
Fax
Email
F.akhlaghi80@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data is segmented after unrecognizable individuals in the thesis or article.
When the data will become available and for how long
Access period starts from 2025
To whom data/document is available
It will be available to everyone
Under which criteria data/document could be used
Researchers are licensed by the Research Committee
From where data/document is obtainable
After publishing the article, visit the magazine site for more information by writing to the address:F.akhlaghi80@gmail.com
What processes are involved for a request to access data/document
Researchers can receive the necessary response after two weeks by sending an email to the person in charge.