Importance: Debate over the evidence for Ayres Sensory Integration® (ASI) is ongoing; previous reviews have reached mixed conclusions.

Objective: To evaluate the efficacy of ASI for children, based on a systematic review of randomized controlled trials (RCTs).

Data Sources: Searches of the Cochrane Library, MEDLINE, CINAHL, PsycINFO, and Embase databases.

Study Selection and Data Collection: We followed Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. RCTs were published in peer-reviewed English-language literature and compared implementation of ASI with its Fidelity Measure™ with children ages 0 to 12 yr with treatment as usual, other treatment, or no treatment. Data were extracted using the Template for Intervention Description and Replication Checklist; risk of bias was assessed with the Cochrane risk-of-bias tool for randomized trials.

Findings: Nine RCTs (N = 344 participants), six with autistic children and three with other child populations, were included. RCTs were categorized as Level 1b (well designed) or 2b (low quality); strength of evidence was determined according to U.S. Preventive Services Task Force guidelines. Strong evidence from five RCTs (four Level 1b) indicates that ASI supports autistic children in meeting their individualized goals. Moderate evidence from three RCTs (two Level 1b) indicates no benefits of ASI for behaviors of concern, such as noncompliance or irritability. Bias concerns persist among included studies.

Conclusions and Relevance: ASI supports autistic children’s individualized goals related to occupational performance, function, and participation. It is not recommended to address behaviors of concern, such as resistance to change or irritability. More research is needed to determine ASI’s benefits for other child populations.

Plain-Language Summary: Debate over the uses of Ayres Sensory Integration® (ASI) with children accessing occupational therapy is ongoing. Previous systematic reviews used varied and inconsistent definitions of ASI interventions, included mixed methodologies of various quality, and arrived at mixed conclusions. This review addressed these concerns by focusing exclusively on high-level studies of ASI that adhered to the ASI Fidelity Measure™, providing valuable insights into the outcomes of ASI for children (age 0–12 yr). When ASI was conducted under fidelity, the evidence suggested that autistic children significantly improved in their individualized goals related to occupational performance, function, and participation. Research that included outcomes related to behaviors of concern, such as noncompliance or irritability, indicated no benefit of ASI. Emerging evidence reveals some functional and developmental benefits for autistic children and other child populations; further research is needed to support the observed outcomes.

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