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A stepped design study of the effects of the BTR strategy on autism spectrum disorders in children

A stepped design study of the effects of the BTR strategy on autism spectrum disorders in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100350
Enrollment
Unknown
Registered
2025-04-08
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Autism Spectrum Disorder

Interventions

2 years old <= age < 4 years old:The BTR intervention was given at 1 month to 6 months of enrollment according to the time point of the stepwise design.
4 years old <= age < 6 years old:The BTR intervention was given at 1 month to 6 months of enrollment according to the time point of the stepwise design.

Sponsors

Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Age at the time of enrollment is 2 weeks old~6 years old 2. Standardized diagnosis of ASD according to the 2013 Diagnostic and Statistical Manual of Mental Disorders (5th edition). 3No previous treatment with psychotropic medication 4. The family members were informed and agreed to be enrolled according to the randomization method, and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of severe mental retardation, mental retardation 2. Clear abnormalities in cranial imaging, microcephaly 3. Diseases caused by known chromosomal or genetic abnormalities are found 4. Previously treated with psychotropic drugs. 5. Family members were informed but refused to be enrolled.

Design outcomes

Primary

MeasureTime frame
ASD assessment;

Secondary

MeasureTime frame
Intellectual assessment;Assessment of co-morbidities;

Countries

China

Contacts

Public ContactXiangyang Luo

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

luoxy33@139.com+86 136 0283 8578

Outcome results

None listed

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