A Multi-Site Randomized Control Trial of Family Navigation’s Effect on Diagnostic Ascertainment Among Children at Risk for Autism: A Dbpnet Study

Background: Significant racial, ethnic, and socioeconomic disparities exist in access to diagnostic and evidence-based treatment services for children with autism spectrum disorder (ASD). Barriers to timely ASD diagnostic and treatment services can result from various factors including the availability of services, patient-provider miscommunication, parental stress, and culturally biased care. Family navigation (FN) is a care management strategy designed to reduce disparities in access to care, through provision of intensive, individually tailored, care coordination and family support.

Objectives: The purpose of this study was to test the effectiveness of FN to reduce time to diagnosis and increase access to treatment services for children at risk for ASD.

Methods: In this large, multi-site randomized comparative effectiveness trial, families of children at risk for ASD were recruited from urban clinics in Massachusetts (n = 6 clinics), Connecticut (n = 2), and Pennsylvania (n = 2). Eligible children were between the ages of 15-27 months (n = 250), who screened positive for ASD at a primary care visit. Families were randomized to receive either FN or enhanced usual care (eUC). FN families worked with a bilingual, bicultural navigator trained in motivational interviewing, who met with families in the community, conducted outreach to service agencies as needed, and reminded families about upcoming appointments. eUC families received access to a clinic-based care manager, who addressed parent and provider concerns but did not actively reach out to families. Families received FN or eUC throughout their child’s developmental assessment and for 100 days post-diagnosis.

Results: The trial successfully enrolled the desired target population: young, low-income, racially diverse children. The average age of enrolled children was 21.7 months. 12.4% of children in the study were white, 54.8% were black/African-American, 6.4% were Asian, and 5.2% were mixed-race. 29.0% were Hispanic and 82.4% were covered by public insurance. Children scored an average of 8.6 (SD=3.1) on the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (MCHAT-R/F) at time of enrollment in the study, with no significant differences reported between the FN or eUC groups. Approximately 60% of all children received an ASD diagnosis, with no significant differences between children who received FN versus eUC. By 90 days after enrollment, significantly more children in the FN group had achieved diagnostic resolution than those in the eUC group (55% versus 41%, p=0.022). By 1-year after enrollment, children who received FN had more than twice the odds of reaching diagnostic resolution as compared to children who received eUC, 86.6% vs 74.8%, respectively (Odds Ratio, 95% Confidence Interval, p-value; 2.18, 1.14-4.19, 0.019).

Conclusions: This study supports the effectiveness of FN to improve rates of ASD diagnostic resolution among urban minority, low-income children who are detected as “at-risk” for ASD in primary care. Because a formal medical ASD diagnosis is required in the majority of states to access early-intensive evidence-based ASD services, these findings support the use of FN to assure timely access to diagnosis, and ultimately services, for low-income, urban children.