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A study of the effectiveness and scalability of a father-inclusive group-based early childhood development program in China

A study of the effectiveness and scalability of a father-inclusive group-based early childhood development program for rural caregiver-child dyads in Zhejiang Province, China

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13421990
Enrollment
660
Registered
2024-07-08
Start date
2024-07-26
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early childhood developmental delay Other

Interventions

Current interventions as of 14/08/2025: The present study is a group-based prospective, cluster-randomized controlled, superiority trial. Using a random number generator subjects were assigned to trea

Sponsors

Zhejiang University Qingshan Institute for Advanced Studies in Business
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 6 - 24 months of age and their caregivers living in the sample region at the time of baseline data collection 2. With a rural household registration status (hukou) 3. Willing to participate in the parenting support program 4. Willing to participate in the impact evaluation, including the child surveys, caregiver surveys, and household surveys 5. Able and willing to give informed consent

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 14/08/2025: 1. Children and caregivers residing in clusters with a low prevalence of developmental delays (i.e., a prevalence of less than 20%) 2. Children and caregivers who are not residing in the region 3. Children whose mothers have an urban household registration status 4. Children with severe disabilities 5. Caregivers who are unwilling or unable to give informed consent 6. Caregivers who are unwilling to participate in the intervention program Previous exclusion criteria: 1. Children and caregivers residing in clusters with a low prevalence of developmental delays (i.e., a prevalence of less than 20%) 2. Children and caregivers who are not residing in the region 3. Children with urban household registration status 4. Children with severe disabilities 5. Caregivers who are unwilling or unable to give informed consent 6. Caregivers who are unwilling to participate in the intervention program

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 14/08/2025: All measures will be collected at baseline and at follow-up (i.e., after completion of the 9-month intervention program): 1. Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) 2. Brief Infant-Toddler Social and Emotional Assessment (BITSEA) (only at baseline) 3. Ages & Stages Questionnaire: Social-Emotional (ASQ:SE) (only at follow-up) Previous primary outcome measures: All measures will be collected at baseline and at follow-up (i.e., after completion of the 1-year intervention program): Infants: 1. Birth information (only at baseline) 2. Basic demographic characteristics (only at baseline) 3. Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) 4. Brief Infant-Toddler Social and Emotional Assessment (BITSEA) 5. Ages & Stages Questionnaires (ASQ-3)

Secondary

MeasureTime frame
Current secondary outcome measures as of 14/08/2025: All measures will be collected at baseline and at follow-up (i.e., after completion of the 9-month intervention program): 1. EuroQol Toddler and Infant Populations (EQ-TIPS) 2. Child Screen Time (7 self-made items) 3. Family Care Indicators (FCI) 4. Karitane Parenting Confidence Scale (KPCS) (only at baseline) 5. Chinese Version of the Parenting Sense of Competence Scale (C-PSOC) (only at baseline) 6. Parenting Cognitions and Conduct Toward the Infant Scale (PACOTIS) 7. Child Gender Socialization Scale (CGSC) 8. Depression Anxiety Stress Scale (DASS-21) 9. Parental Stress Scale (PSS) 10. Multidimensional Scale of Perceived Social Support (MSPSS) Previous secondary outcome measures: All measures will be collected at baseline and at follow-up (i.e., after completion of the 1-year intervention program): 1. Caregivers: 1.1. Chinese Version of the Parenting Sense of Competence Scale (C-PSOC) 1.2. Parenting Cognitions and Conduct Toward the Infant Scale (PACOTIS) 1.3. Depression Anxiety Stress Scale (DASS-21) 1.4. Center for Epidemiologic Studies Depression Scale (CES-D) 1.5. Parenting Stress Index Short Form (PSI-SF) 1.6. Multidimensional Scale of Perceived Social Support (MSPSS) 2. Parenting environment: 2.1. Composition of family members 2.2. Family socio-economic status (adult education, job, income, family property) (only at baseline) 2.3. Parents' migration history (only at baseline) and current place of residence 2.4. Health status of family members 2.5. Information on the network of social relationships among the sample families

Countries

China

Contacts

Public ContactYun Shen
shenyun_@zju.edu.cn+86 57185172244

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026