A randomized controlled trial of routines-based early intervention for children with or at risk for developmental delay.

Routines-based early intervention (RBEI) for children with or at risk for developmental delay encourages collaboration between professionals and families to enhance children's participation in family routines with family-selected goals. We conducted the first single-blinded randomized control trial to examine the effectiveness of a 6-month RBEI vs. traditional home visiting (THV), which uses a curriculum focused on children's developmental domains. Thirty-one families with children aged 5-30 months (mean age 17.4 months) with or at risk for developmental delay were randomly assigned to an RBEI group (n=15) or a THV group (n=16). The enrolled children were evaluated using the Chinese version of Pediatric Evaluation of Disability Inventory (PEDI-C) and the Comprehensive Development Inventory for Infants and Toddlers (CDIIT) at 5 time points. Two-way mixed analysis of variance (ANOVA) was used to examine the group by stage interactions. Goal Attainment Scaling (GAS) and the Canadian Occupational Performance Measure (COPM) were applied to explore between-group differences on individualized goal achievement. PEDI-C showed that the RBEI group had a faster progress rate in self-care functions and independence in social functions in the first 3 months of intervention and at the 6-month follow-up. The RBEI group also scored higher on the GAS in the first 3 months of intervention. However, between-group differences in changes in the developmental domains on the CDIIT were not significant. Thus, RBEI was more effective than THV in promoting functional outcomes and reaching family-selected goals, while both interventions allowed equal improvement in developmental domains.