Resilience Training Intervention: Its Effect on Parental Acceptance/Rejection and Burden of Children With Down Syndrome

December 14, 2025 updated by: Ain Shams University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11566
        • Medical Research Centre of Excellence which is affiliated to National Research Centre (NRC).
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fatma Mohammed Ibrahim Morsy, Assistant Professor
        • Sub-Investigator:
          • Samah Gaber Hassan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Biological parent (mother or father) of a child (birth to 3 years old) diagnosed with Down syndrome.
  • 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:

  • Presence of severe mental illness (e.g., psychosis) or cognitive impairment that would hinder participation.
  • Current enrollment in another structured psychological or parenting program aimed at resilience or acceptance.
  • Any acute medical condition preventing attendance of the sessions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resilience Training Intervention (experimental)
Resilience Training Intervention
Behavioral: 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.
No Intervention: Usual Care (Control)
Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Acceptance-Rejection scale
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.
Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Caregiver Burden Score
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
Baseline, immediately post-intervention, and 1-month follow-up
Change in Maternal Resilience
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.
Baseline, post-intervention, 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

December 14, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24.03.250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Down Syndrome

Clinical Trials on resilience training intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe