Resilience Training Intervention: Its Effect on Parental Acceptance/Rejection and Burden of Children With Down Syndrome
NCT ID: NCT07306923
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-12-31
2026-04-30
Brief Summary
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Parents who care for a child with Down syndrome often face stress and emotional challenges. Building psychological resilience-the ability to adapt and recover from stress-may improve how parents cope and relate to their children.
The study will include about 50 parents of children with Down syndrome. Participants will be randomly assigned to one of two groups:
Experimental group: Receives the resilience training program.
Control group: Receives usual care.
Study phases
Before the program: Parents complete questionnaires that measure their resilience, their acceptance or rejection of their child, and their caregiving burden.
During the program: Parents in the experimental group attend a structured resilience training program based on their expressed needs.
After the program: The same questionnaires are repeated immediately after the program and again at a follow-up to see if any changes last.
The research hypothesis is that parents who take part in the resilience training will show higher acceptance, lower rejection, and reduced caregiving burden compared with parents who receive usual care.
This study will provide evidence on whether resilience training is a helpful, practical, and safe way to support families raising a child with Down syndrome.
Detailed Description
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Design
A non-randomized, controlled, pretest-posttest, repeated-measures design will be used. Approximately 50 parents will be allocated into an experimental group and a control group, based on availability and willingness to participate. Measurements will be taken at baseline, immediately post-intervention, and at follow-up.
Study Phases
Phase 1 - Needs assessment and program development
Assess baseline resilience, parental acceptance/rejection, and caregiving burden.
Develop and implement a tailored resilience training intervention based on identified needs.
Phase 2 - Evaluation
Evaluate the intervention's effect on parental acceptance/rejection.
Evaluate the intervention's effect on parental caregiving burden.
Intervention
The experimental group will receive a structured resilience training program designed to enhance coping skills, positive reframing, and stress management. The control group will continue with usual care during the same period.
Sample Size and Power
The required sample size was calculated a priori using G\*Power 3.1.9.7 for a repeated-measures ANOVA (within-between interaction) with two groups and three time points.
Assuming a medium effect size (Cohen's f = 0.25), α = 0.05, power = 0.95, correlation among repeated measures = 0.50, and nonsphericity correction ε = 1.0, the analysis indicated 44 participants (22 per group).
To account for about 10% attrition, 50 participants (25 per group) will be recruited.
Expected Outcome
It is hypothesized that the resilience training will increase parental acceptance and reduce rejection and burden compared with usual care, despite the non-random allocation. Findings may guide family-centered mental-health programs for parents of children with Down syndrome.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Resilience Training Intervention (experimental)
Resilience Training Intervention
resilience training intervention
A structured resilience training program delivered to parents of children with Down syndrome. The program consists of sessions designed to improve psychological resilience, enhance parental acceptance, and reduce caregiving burden. Training methods may include group discussions, skill-building exercises, and home practice tasks.
Usual Care (Control)
Usual Care
No interventions assigned to this group
Interventions
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resilience training intervention
A structured resilience training program delivered to parents of children with Down syndrome. The program consists of sessions designed to improve psychological resilience, enhance parental acceptance, and reduce caregiving burden. Training methods may include group discussions, skill-building exercises, and home practice tasks.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older.
* Able to read and understand the study questionnaires and provide informed consent.
* Willing to attend all resilience training sessions (for the experimental group).
* parents who are not responsible for caring of any other patients in the family
Exclusion Criteria
* Current enrollment in another structured psychological or parenting program aimed at resilience or acceptance.
* Any acute medical condition preventing attendance of the sessions.
18 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Locations
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Medical Research Centre of Excellence which is affiliated to National Research Centre (NRC).
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Fatma Mohammed Ibrahim Morsy, assistant professor
Role: CONTACT
Phone: +201144500853
Email: [email protected]
Facility Contacts
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Fatma Mohammed Ibrahim, assistant professor
Role: primary
Role: backup
Other Identifiers
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24.03.250
Identifier Type: -
Identifier Source: org_study_id