A cluster randomized controlled trial comparing the effectiveness of two school-based interventions for autistic youth with anxiety.

"Declarations Ethics approval and consent to participateAll procedures performed in studies involving human participants are in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. All Institutional Review Boards (University of Colorado, University of North Carolina, and Emory University) approved this study; COM-IRB Protocol #23–0521; UNC Protocol #23–1630; Emory Protocol #00006641). Informed consent will be obtained as follows: Recruitment for schools and school districts will include an informational email and follow-up presentations about the study. If school districts are interested, we will submit the study protocol through each school district’s or school’s research approval processes. Following school or district research approval processes, individual schools, each with at least two school providers, will be nominated by school administrators. Research staff will obtain their consent to participate in the study prior to training in FYF-SB or ZOR. After training, we will ask participating school providers from each respective intervention to send recruitment materials home to parents/caregivers of autistic students 8–14 years of age with suspected autism and anxiety. Recruitment materials explain what is expected of research participants and detail all research activities. If interested, parents/caregivers will give permission for their school providers to share their contact information with the research team. The research team will then email and call the parents/caregivers, and obtain informed consent over the phone, Zoom, or in-person. Student assent will also be obtained in-person with students at their schools following caregiver consent. Consent for publicationNot applicable. Competing interestsJR receives royalties for the sales of the clinic version of Facing Your Fears (FYF). Competing interests JR receives royalties for the sales of the clinic version of Facing Your Fears (FYF)."

"Funding disclaimer All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee. Funding This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (Contract: 0000064160)."

"Trial registration This trial is registered with clinicaltrials.gov (NCT05863520)."