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A study to Promote Nurturing Care using the International Guide for Monitoring Child Development (GMCD) as a tool.

An Individualized Approach to Promote Nurturing Care in Low- and Middle-Income Countries: A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029748
Enrollment
624
Registered
2020-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

None listed

Interventions

Intervention1: International Guide for Monitoring Child Development (GMCD): The study intervention is administration of the International Guide for Monitoring Child Development (GMCD) by frontline hea

Sponsors

National Institutes of Health National Institute of Child Health and Human Development
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 0-24 months at the time of enrollment visit, and receiving health services from frontline health workers of Maya Health Alliance (Guatemala), Mahatma Gandhi Institute (India) or their local partners.

Exclusion criteria

Exclusion criteria: Children who are critically ill and are judged by the frontline health worker to require hospitalization or center-based care; children whose caregivers do not provide informed consent for the study.

Design outcomes

Primary

MeasureTime frame
Child development assessed using Bayley Scales of Infant DevelopmentTimepoint: Baseline (0 months), 12 months and 24 months—

Secondary

MeasureTime frame
Assess barriers and facilitators to GMCD implementation using the RE-AIM evaluation framework.Timepoint: RE-AIM domains will be assessed as: (a) Reach: participation rates, comparison of participant/non-participant characteristics, attendance/drop-out; (b) Effectiveness: impact on development (BSID3) and nurturing environment (HOME); (c) Adoption: proportion of workers/facilities participating, CHW characteristics; (d) Implementation: contact hours/visit completion, fidelity to delivery protocols; (e) Maintenance: patient outcomes and cost effectiveness analysis at 12-24 months;Conduct an economic evaluation of the GMCD intervention.Timepoint: Evaluation will assess (a) costs of the interventions at 12 and 24 months; and (b) cost-effectiveness of the intervention (dollar per unit increase in BSID or HOME scores) at 12 months.;The secondary nurturing care effectiveness outcome will be change in mean Home Observation for Measurement of the Environment (HOME) scoreTimepoint: Change in mean Home Observation for Measurement of the Environment (HOME) score at 12 months.—

Countries

Guatemala, India

Contacts

Public ContactDr Subodh Sharan Gupta

Mahatma Gandhi Institute of Medical Sciences, Sevagram

subodhsgupta@gmail.com9822926934

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026