NCT Number: NCT07306923
This research will test whether a resilience training program can help parents of children with Down syndrome feel more accepting of their child and experience less caregiving burden.
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 11566, Egypt
Fatma Mohammed Ibrahim Morsy, Assistant Professor
PRINCIPAL_INVESTIGATOR
Fatma Mohammed Ibrahim, assistant professor
CONTACT
Samah Gaber Hassan, PhD
SUB_INVESTIGATOR
CONTACT
This quasi-experimental study will evaluate the effectiveness of a resilience training intervention on parental acceptance/rejection and caregiving burden among parents of children with Down syndrome.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
Mean change in parental acceptance-rejection score of parents of children with Down syndrome, measured using the Parental Acceptance-Rejection Questionnaire (PARQ) at baseline, immediately post-intervention, and 1-month follow-up.
Time frame: Baseline, immediately post-intervention, and 1-month follow-up
Mean change in caregiver burden using Zarit Burden Interview at baseline, immediately post-intervention, and 1-month follow-up
Time frame: Baseline, post-intervention, 1-month follow-up
Mean change in maternal resilience measured using the Maternal Resilience Scale (MRS) at baseline, immediately post-intervention, and 1-month follow-up. Higher scores indicate greater resilience.
Contact information is provided by the study sponsor or research team.
Ain Shams University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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