NCT07306923

Brief 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. 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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 29, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

December 14, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

resilience trainingparental acceptanceparental burdencaregiver stressbehavioral interventionpsychological resilienceparental rejection

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up

Secondary Outcomes (2)

  • Change in Caregiver Burden Score

    Baseline, immediately post-intervention, and 1-month follow-up

  • Change in Maternal Resilience

    Baseline, post-intervention, 1-month follow-up

Study Arms (2)

Resilience Training Intervention (experimental)

EXPERIMENTAL

Resilience Training Intervention

Behavioral: resilience training intervention

Usual Care (Control)

NO INTERVENTION

Usual Care

Interventions

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.

Resilience Training Intervention (experimental)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Centre of Excellence which is affiliated to National Research Centre (NRC).

Cairo, Cairo Governorate, 11566, Egypt

Location

MeSH Terms

Conditions

Down SyndromeCaregiver Burden

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornStress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Fatma Mohammed Ibrahim Morsy, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-arm, non-randomized, parallel-group design comparing resilience training with usual care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2025

First Posted

December 29, 2025

Study Start

December 1, 2025

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

December 29, 2025

Record last verified: 2025-09

Locations