External Evaluation of the Neurological and Psycho-affective Early Childhood Development Program of the Mexican NGO Un Kilo de Ayuda
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Child Development
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A variation of the stepped wedge cluster randomized trial design was specified. Due to ethical and logistical considerations, the intervention in study groups under this design starts sequentially but measurements are performed at the same time period in all groups. The key difference between groups is thus the time of exposure to the intervention. Clusters were randomized into four study groups (30, 24, and 12 months of exposure, and a non-exposed group). The intervention consists of educational workshops for caregivers aimed at promoting healthy nurturing care practices and responsive caregiving. Assessment of intervention effects is performed as in a parallel design.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 160 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04210362
- Collaborators
- Un Kilo de Ayuda A.C.
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Investigators
- Principal Investigator: Edson Serván-Mori, PhD Mexican National Institute of Public Health
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