Down SyndromeNCT07306923
Resilience Training Intervention: Its Effect on Parental Acceptance/Rejection and Burden of Children With Down Syndrome
A study testing resilience training intervention in people with Down Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- resilience training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fatma Mohammed Ibrahim Morsy, assistant professor contact
Egypt1 site
Medical Research Centre of Excellence which is affiliated to National Research Centre (NRC).
Cairo, Cairo Governorate, 11566
Fatma Mohammed Ibrahim, assistant professor, +201144500853, dr.fatma.ibrahim@nursing.asu.edu.eg
dr.fatma.ibrahim@nursing.asu.edu.eg
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- resilience training intervention
- Keywords
- resilience training, parental acceptance, parental burden, caregiver stress, behavioral intervention, psychological resilience, parental rejection
- Medical subject headings
- Down Syndrome, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resilience training interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resilience Training Intervention (experimental) | Experimental | Resilience Training Intervention Receives: Behavioral: resilience training intervention |
| Usual Care (Control) | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Acceptance-Rejection scale
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.
Measured: Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
Secondary outcomes (2)
Change in Caregiver Burden Score
Mean change in caregiver burden using Zarit Burden Interview at baseline, immediately post-intervention, and 1-month follow-up
Measured: Baseline, immediately post-intervention, and 1-month follow-up
Change in Maternal Resilience
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.
Measured: Baseline, post-intervention, 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, non-randomized, parallel-group design comparing resilience training with usual care.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306923
- Sponsor's protocol ID
- 24.03.250
- Status last verified
- Sep 2025
- First submitted
- 14 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Training Intervention: Its Effect on Parental Acceptance/Rejection and Burden of Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07306923
- Acronym / sponsor ID
- 24.03.250
- Conditions
- Down Syndrome
- Keywords
- resilience training, parental acceptance, parental burden, caregiver stress, behavioral intervention, psychological resilience, parental rejection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, non-randomized, parallel-group design comparing resilience training with usual care.
| Arm | Type | Receives |
|---|---|---|
| Resilience Training Intervention (experimental) | Experimental | Behavioral: resilience training interventionResilience Training Intervention |
| Usual Care (Control) | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resilience training interventionA 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. | Behavioural | Resilience Training Intervention (experimental) |
Primary outcome
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.
2 secondary outcomes
Change in Caregiver Burden Score
Time frame: Baseline, immediately post-intervention, and 1-month follow-up
Change in Maternal Resilience
Time frame: Baseline, post-intervention, 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatma Mohammed Ibrahim Morsy, assistant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resilience training intervention in people with Down Syndrome, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Mohammed Ibrahim Morsy, assistant professor (+201144500853, dr.fatma.ibrahim@nursing.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Acceptance-Rejection scale (time frame: Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.