Exploratory Evaluation of Staff-Mediated Doll Therapy in Chinese Residential Dementia Care: A Mixed-Methods Cluster Randomized Pilot Trial

This study is a two-phase explanatory sequential mixed-methods study in Chinese residential dementia care. Phase I is a pragmatic 1:1 exploratory pilot cluster randomized trial in six nursing homes in Zhengzhou, China, comparing staff-mediated doll therapy plus routine nursing care with routine nursing care alone among 142 residents with dementia assessed at baseline, 6 weeks, and 12 weeks. Registered primary outcomes are class-specific daily medication-dose trajectories for antipsychotics, anxiolytics, and antidepressants. Secondary and contextual outcomes include behavioral and psychological symptoms of dementia, activities of daily living, cognitive enhancer use, traditional Chinese medicine use, and doll engagement/adherence. Phase II uses semi-structured interviews with staff and family caregivers to explore acceptability, implementation, training needs, cultural fit, and ethical considerations.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Doll Therapy

Detailed Description

Doll therapy is a person-centered, attachment-informed non-pharmacological intervention in which a person living with dementia is offered a lifelike doll and may interact with it by holding, comforting, grooming, or talking to it. This exploratory pilot and feasibility mixed-methods cluster randomized trial evaluates a staff-mediated doll-therapy care package in Chinese nursing homes. Intervention homes receive staff training, a structured introduction to a personal doll, relational engagement during routine care, and ongoing monitoring of resident assent, dissent, distress, and fit. Control homes provide routine nursing care alone. Quantitative assessments are conducted at baseline, 6 weeks, and 12 weeks. Medication-related outcomes are interpreted as indirect health-service and medication-burden signals rather than as direct evidence of prescribing causation. Behavioral, functional, contextual medication, traditional Chinese medicine, and engagement measures are interpreted alongside qualitative interviews with staff and family caregivers to understand implementation, acceptability, cultural fit, and ethical safeguards. Because only six clusters are randomized, the study is intended to generate feasibility information, preliminary effect estimates, and implementation signals rather than definitive clinical-effect evidence.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 451100
      • Sias University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 65 years or older.
• Nursing home resident with a documented clinical diagnosis of dementia recorded in the medical or nursing-home record by a qualified physician using DSM-5, ICD-10, ICD-11, or current Chinese clinical guidelines for dementia and cognitive impairment; where the underlying diagnostic criteria were not specified in the record, the site clinician reconfirmed the diagnosis against DSM-5 criteria before enrollment.
• Adequate visual capacity to recognize a doll at screening.
• Sufficient upper-limb function to hold or caress the doll safely.
• Availability of a legally authorized representative able to provide written informed consent.
• Resident assent whenever appropriate.

Exclusion Criteria:

• Acute medical instability.
• Severe sensory or physical limitations preventing safe participation.
• Severe communication impairment precluding meaningful participation.
• Major psychiatric disorders unrelated to dementia.
• Resident dissent or refusal when assent was appropriate, or safety concerns that made doll interaction unsuitable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Staff-Mediated Doll Therapy plus Routine Nursing Care; Residents in intervention homes received routine nursing care plus a staff-mediated doll-therapy care package. The package included staff training, a structured doll-therapy introduction with eight planned sessions over approximately 15 days, continued access to a personal doll during routine care, structured interaction and relational engagement, and ongoing monitoring of resident assent, dissent, distress, and fit.	Behavioral: Doll Therapy; Staff-mediated doll therapy is a person-centered, attachment-informed non-pharmacological care package in which trained nursing-home staff introduce a lifelike doll respectfully, support resident-led interaction, monitor assent and dissent, and provide continued access to a personal doll during routine care. The intervention included eight planned introductory sessions over approximately 15 days, structured interaction, relational engagement, and implementation within ordinary nursing-home care.
No Intervention: Routine Nursing Care; Residents in control homes received routine nursing care alone. Control homes did not receive study-provided dolls or structured doll-therapy training during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Class-Specific Daily Medication Dose	This primary outcome assesses class-specific mean daily medication-dose trajectories for antipsychotics, anxiolytics, and antidepressants over 12 weeks. Antipsychotics are expressed as chlorpromazine-equivalent daily dose, anxiolytics as diazepam-equivalent daily dose, and antidepressants using the WHO defined daily dose framework. Changes are compared between doll therapy plus routine nursing care and routine care alone.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Behavioral and Psychological Symptoms of Dementia (BPSD)	This secondary outcome measure will evaluate the change in behavioral and psychological symptoms of dementia (BPSD) using the Neuropsychiatric Inventory (NPI-12). This inventory includes 12 domains such as delusions, hallucinations, agitation/aggression, depression, anxiety, and others. The scores will be measured and compared between the intervention and control groups. The NPI-12 scores range from 0 to 144, with higher scores indicating more severe symptoms.	12 weeks
Change in Activities of Daily Living (ADL)	This secondary outcome measure will assess the change in activities of daily living (ADL) using the Chinese version of the Barthel Index of ADL. This index measures the functional independence of participants in performing daily activities such as feeding, bathing, dressing, toileting, transferring, and walking. The scores will be measured and compared between the intervention and control groups. The Barthel Index scores range from 0 to 100, with higher scores indicating better functional independence.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Enhancer Use	Cognitive enhancer use is evaluated as a secondary/contextual medication outcome over 12 weeks and expressed in donepezil-equivalent daily dose where applicable. Changes are compared between doll therapy plus routine nursing care and routine care alone.	12 weeks
Change in Traditional Chinese Medicine Use	Traditional Chinese medicine use is summarized as a context-specific composite score incorporating formula complexity, dosage, frequency, and duration. This contextual outcome is evaluated over 12 weeks and compared between doll therapy plus routine nursing care and routine care alone.	12 weeks
Doll Engagement and Adherence	Within intervention homes, structured session records document doll acceptance, session attendance, resident assent or dissent, and sustained engagement with the doll. Engagement and adherence are summarized descriptively and used for contextual interpretation and per-protocol sensitivity analysis.	12 weeks

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Zhenti Cui, Social and Preventive Medicine, Malaya University

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: LL20240509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified quantitative analysis-ready data underlying the reported results and analytic code may be shared with qualified researchers on reasonable request. Because the dataset contains potentially identifiable nursing-home clinical information, data will not be posted publicly. The qualitative coding framework may also be available on reasonable request.
• IPD Sharing Time Frame: 3 months to 5 years following article publication
• IPD Sharing Access Criteria: Researchers must provide a methodologically sound proposal and obtain appropriate ethics and institutional approvals where required. Access will be subject to review by the study team and the responsible institution, and requestors must sign a data access agreement covering confidentiality, permitted use, and secure storage.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No