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Applying Target Trial Emulation to Evaluate Acupuncture Combined with Rehabilitation for Autism Spectrum Disorder in
Xing Wang1, Rui-Xuan Zhu2, Xiao-Gang Du1
1Xi'an TCM Hospital of Encephalopathy, Shaanxi University of Chinese Medicine, Xi'an, Shaanxi, 710032, People's Republic of China.
Background:
Target trial emulation (TTE) has recently emerged as an innovative methodological framework for deriving causal inference from real-world data. Its use in complementary and integrative medicine, however, remains limited. This protocol applies TTE to evaluate the effectiveness of acupuncture combined with rehabilitation in children with ASD, aiming to generate rigorous real-world evidence and bridge the current evidence gap.
Methods:
This retrospective TTE study will utilize anonymized data from the ASD registry of Xi'an TCM Hospital of Encephalopathy affiliated to Shaanxi University of Chinese Medicine. Children aged 2-12 years diagnosed with ASD according to DSM-5 criteria will be included. The intervention group will receive rehabilitation therapy plus acupuncture, while the control group will receive standard rehabilitation therapy alone. A total of approximately 250-300 participants will be included, ensuring at least 180 matched cases after propensity score matching. Statistical analyses will include paired t-tests, multivariable regression, and correlation analyses to estimate treatment effects and control for confounding. The TTE defines a clear time-zero (treatment initiation), prespecified censoring and crossover rules, and a causal estimand focusing on the average treatment effect among the treated (ATT). Balance diagnostics and sensitivity analyses will be performed to assess robustness.
Anticipated Results:
This study is designed to evaluate whether acupuncture combined with rehabilitation leads to greater improvements in ATEC and ABC scores compared with rehabilitation alone. Exploratory neuroimaging analyses will be conducted to investigate potential mechanisms underlying treatment effects.
Conclusion:
This protocol aims to evaluate the effectiveness of acupuncture combined with rehabilitation for children with ASD using a target trial emulation framework applied to real-world data. The study is designed to estimate the causal effect (ATT) while addressing confounding and missing-data issues, and its findings-whether positive or null-will inform future RCT design and the evidence-based integration of acupuncture in neurodevelopmental care.
Clinical Trial Number:
Not applicable.
