Staff-mediated doll therapy in Chinese residential dementia care: an exploratory pilot and feasibility mixed-methods cluster randomized clinical trial

Background Doll therapy is a person-centered intervention for behavioral and psychological symptoms of dementia, but evidence from Chinese nursing homes and information about implementation, medication use, and ethical acceptability remain limited. Methods We conducted an exploratory pilot and feasibility mixed-methods cluster-randomized clinical trial in six nursing homes in Zhengzhou, China. Homes were randomized 1:1 to a staff-mediated doll-therapy care package plus routine care or routine care alone. Residents with dementia were assessed at baseline, 6 weeks, and 12 weeks. Registered primary outcomes were class-specific standardized daily psychotropic doses; NPI-12 was the main proximal clinical outcome. Feasibility, fidelity, safety, and interviews with intervention-home staff and family caregivers were also evaluated. Marginal models used nursing home as the top-level cluster and the Mancl-DeRouen small-sample variance correction. Results Among 185 residents screened, 142 were enrolled, and 130 (91.5%) completed 12-week follow-up. Sixty-eight of 71 intervention participants (95.8%) attended at least 6 of 8 sessions; mean fidelity was 94.1%. The intervention-control difference in NPI-12 change was −3.61 points at 6 weeks (95% confidence interval [CI], −5.86 to −1.36) and −4.40 at 12 weeks (95% CI, −6.50 to −2.30). The Barthel difference was 3.96 points at 6 weeks (95% CI, 1.06 to 6.86) and 3.07 at 12 weeks (95% CI, −2.33 to 8.47). All medication-dose intervals showed no difference. Six possible or probable related events were mild or moderate; no serious event was related. Interviews with 15 staff and 9 family caregivers indicated engagement for some residents, absent or adverse responses for others, and the importance of training, non-deceptive introductions, prompt respect for refusal, and operational ownership. Conclusion The care package was feasible and produced a preliminary behavioral signal, but medication effects were imprecise, and functional improvement was not sustained. A larger cluster trial with an attention-control condition is required. Trial registration ClinicalTrials.gov , NCT06506487; https://clinicaltrials.gov/study/NCT06506487 .