Pilot Randomised Controlled Trial of the Who Caregiver Skills Training in Public Child Neuropsychiatry Services in Italy

Background: Access to publicly-available, evidence-based early intervention for ASD is very limited even in high-income European countries, including Italy. The WHO Caregiver Skills Training (CST) program is evidence-based and meets affordability and feasibility criteria for implementation in public health settings. Following a formative adaptation process and pre-pilot implementation showing good acceptability and appropriateness to the local context, a pilot randomized controlled trial (RCT) of the WHO CST was conducted in rural and low-resourced urban areas in Northern Italy.

Objectives: to examine acceptability and feasibility of community-implemented CST; to pilot RCT processes.

Methods: The study is a two-arm pilot RCT of CST against enhanced treatment as usual (eTAU: one psychoeducation session in addition to TAU). Research assessments are at baseline, 3-month endpoint, and 9-month follow-up. Families were recruited in two waves through public Child Neuropsychiatry Services. Inclusion criteria were: clinical diagnosis of ASD; age 2-5 years; caregiver with sufficient level of Italian language to benefit from the intervention. Following baseline ascertainment (assessments of child autism severity and cognitive ability), participants were randomly assigned to either CST or eTAU on a 1:1 allocation ratio using stratified randomisation by age and autism severity. The CST program was delivered per manual by 6 pairs of local clinicians, who met CST fidelity criteria; CST group size varied from 5 to 8 families. Participation in the program was open to 1-2 caregivers per family; data were collected on the target caregiver/child dyad. Feedback forms and focus groups were used to record the facilitator and caregivers’ experience. Main outcomes reported will be caregiver/child interaction data, caregiver self-efficacy, wellbeing, stress and mental health, child language and adaptive behaviour. Analysis will be by intention-to-treat.

Results: A total of 88 caregiver/child dyads were referred to the study; two did not meet the age criterion. The remaining 86 caregiver/child dyads were enrolled and completed baseline assessments. Sample ethnicity was representative of the Regional population; 16% (n=14) were non-Italian. The randomisation was acceptable to families and effective; children in the two groups (CST, n=43 and TAU, n=43) did not differ by age, autism severity or cognitive ability (ps ranged .786-.802). At the time of submission, CST attendance, endpoint and follow-up data were available only for Wave 1 participants (n=44: CST, n=22 and TAU, n=22). In the CST group, 82% of the target caregivers completed at least 75% of the program and 87% reported adherence to home practice. One caregiver/child dyad dropped-out from the CST program; none dropped-out from the study. All data were complete and research assessments were acceptable. Blinding was maintained. Program materials and contents were considered acceptable by caregivers. Facilitators suggested further adaptation of materials to strengthen psychoeducation messages on caregiver wellbeing and stigma reduction.

Conclusions: Preliminary data indicate that the RCT processes were successful; study retention was high in both groups; CST implementation in community setting (attendance rate; feasibility; acceptability) was satisfactory, suggesting that a full study can proceed. Final results, including treatment effects, will be available for presentation.