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A Double-Blind Randomized Controlled Pilot Trial of e-CST Digital Therapy for Intervention in Children Aged 2–9 with Fragile X Syndrome

A Double-Blind Randomized Controlled Pilot Trial of e-CST Digital Therapy for Intervention in Children Aged 2–9 with Fragile X Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098759
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fragile X syndrome

Interventions

Control group(Group B):intervention as usual
Treatment group(Group A):intervention as usual + e-CST(elearning caregiver skills training)

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 9 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 2-9 years old with FXS can come to the hospital for on-site assessment, have good caregiver compliance, and are willing to cooperate with randomization and follow-up; 2. The caregiver wants to improve the child-rearing skills and is committed to participating in the whole process of the study, agrees to complete the questionnaire and corresponding assessment required for the study according to the real situation, and agrees to follow up after the study is completed; 3. The caregiver agrees to record the parent-child interaction.

Exclusion criteria

Exclusion criteria: 1.Children suffer from severe visual impairment and severe dysaudia.

Design outcomes

Primary

MeasureTime frame
Joint Engagement Rating Inventory(JERI);

Secondary

MeasureTime frame
Caregiver Knowledge and Skills Test(CKST);Parent Sense of Competence(PSOC);Parent Target Problem(PTP);Child and Adolescent Scale of Participation(CASP);Adaptive Behavior Assessment System-Second Edition(ABAS-II);The Repetitive Behavior Scale-Revised(RBS-R);Sensory Profile-2(SP-2);Social Responsiveness Scale, Second Edition(SRS-2);Family Empowerment Scale (FES);Parenting Stress Index-Short Form(PSI-SF);Autism Treatment Evaluation Checklist(ATEC);Clinical Global Impression(CGI);Course Satisfaction Survey?Focus Group;

Countries

China

Contacts

Public ContactYipei Xing

The Third Affiliated Hospital Sun Yat-sen University

xingxyp@163.com+86 15088078836

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026