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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

Xu 2020.

Study name Group‐based intervention to improve developmental status among children age 6–18 months in rural Shanxi province, China
Methods Study design: cluster‐RCT
Country: China
Participants Children aged 6–18 months and their primary caregivers
Inclusion criteria: 
a. aged 4–16 months at the time of recruitment;
b. each child has at least one stable primary caregiver;
c. children and their primary caregivers have no plans to migrate within the next 1 year.
Exclusion criteria:
a. refusal to participate in the study
Stated purpose: to (1) evaluate the effectiveness of an integrated group‐based intervention, the Care Group Intervention, in enhancing ECD amongst children aged 6–18 months and (2) conduct a cost‐effectiveness analysis
Interventions Intervention:
Care Group Intervention
The intervention focuses on five key components, which include good health, adequate nutrition, responsive caregiving, security and safety, and opportunities for early learning under the framework of nurturing care promoted by WHO and UNICEF. The intervention comprises small groups of 3–10 children within a certain age range and their primary caregivers that are led by well‐trained facilitators in the same town. Frequencies are two times per month for children aged 6–23 months and once a month for children aged 24–30 months. The intervention emphasises early learning, responsive caring, security and safety, healthcare, feeding and nutrition, and child protection.
Control:
Usual care (National Public Health Service (NPHS): participants receive free vaccination and health management services for children aged 0–6 years)
Outcomes Participants'outcomes of interest for this review

  1. Mental health symptoms/depression – Center for Epidemiologic Studies Depression Scale (CES‐D)


Economic outcomes
Cost‐effectiveness analysis to examine both the costs and outcomes of the Care Group Intervention
Time points: baseline, post‐intervention (specific time if provided)
Starting date July 2018 (research design and pilot study), April 2019 (sample recruitment and baseline survey)
Contact information Dr Hongyan Guan, cip_ghy@yeah.net
Notes Source of funding: Hong Kong Committee for UNICEF China (Programme No: 0860/A0/05/502)
Prospective trial registration number: ChiCTR1900022894