238 - Inclusion of Families with Limited English Proficiency in Autism Research: A Review of Clinical Trial Registrations

Publication Number: 3230.238

Kate Wallis, Childrens Hospital of Philadelphia, PHILADELPHIA, PA, United States; Mary Grace Harris, MassGeneral Hospital for Children, Everett, MA, United States; Ava Lu, Oregon Health and Science University, Portland, OR, United States; Maria Eaise, Childrens Hospital of Philadelphia, Monroeville, NJ, United States; Chinelo Osakwe, Childrens Hospital of Philadelphia, Philadelphia, PA, United States; Alyssia Liu, Childrens Hospital of Philadelphia, Philadelphia, PA, United States; Karen Kuhlthau, Mass General Brigham for Children, Boston, MA, United States; Katharine E. Zuckerman, Oregon Health & Science University School of Medicine, Portland, OR, United States; Kirsty Valerie. Bernal, Children's Hospital pf Philadelphia, Philadelphia, PA, United States

Background: In the U.S., the number of children living in families with Limited English Proficiency (LEP) is large and growing. As autism spectrum disorder (autism) prevalence increases, prevalence among children in families with LEP is also increasing. Autism is a communication disorder. Thus, including LEP populations in autism research, with appropriate, validated measures and adequate language support, is especially critical. However, the extent to which populations with LEP participate in autism-related clinical trials is unknown.

Objective: To evaluate the inclusion criteria of child-focused autism clinical trials to assess inclusion of populations with LEP.

Design/Methods: We reviewed clinical trials registered on ClinicalTrials.gov from 1/1/2013 to 6/16/25 that a) include autism as condition/disease, b) recruited children/youth aged 0-21 or their caregivers, and c) were conducted in the U.S. A second reviewer extracted data for ~20% of the studies until consensus was reached to ensure reliability. The primary outcome was whether trials explicitly included or excluded participants or caregivers with LEP. We also examined study characteristics, tools used, and language supports. We summarize findings descriptively.

Results: Our search identified 728 eligible ClinicalTrials.gov registrations. To date, we have analyzed 425/728 studies; 9 of these were excluded because they did not include children or their caregivers. Most studies (n=244/416, 58.7%) do not report language requirements for study participation. Of the 164 (39.3%) studies that do report language requirement, 162 (98.8%) mentioned that participants must speak English and 13 (7.9%) mentioned requiring English or Spanish. No other languages were mentioned. Few studies (n=6, 1.4%) mentioned language supports, such as translated materials or interpreters available.

Conclusion(s): Interim analyses indicate that the inclusion of participants with LEP in autism clinical trials is limited, which may affect generalizability of findings and leaves unanswered questions about how communication challenges in autism affect LEP populations.
Limitations: This review of inclusion and exclusion criteria does not reflect actual recruitment and may underestimate English-proficiency requirements among study participants if studies do not have language support available despite not explicitly excluding LEP participants.
Addressing language barriers to research participation is crucial to ensure diverse representation and improve evidence-based care for autistic individuals with LEP. Policy changes and funding are needed to enhance inclusivity in clinical trials.

Figure 1: PRISMA diagram for reviewed studies


Figure 2: Language Requirements
39.4% of studies mention a language requirement. Among those, 90.9% mention an English requirement and 7.9% mention English or Spanish.