A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665297
• Other study ID #: 2020P002143
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: November 2023
• Source: Brigham and Women's Hospital
• Contact: Peter Rohloff
• Phone: 617-447-3034
• Email: prohloff[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to conduct a hybrid effectiveness/implementation assessment of the International Guide for Monitoring Child Development (GMCD) in two LMIC settings, India and Guatemala, within established rural CHW programs. The primary objectives are (a) to evaluate the real-world effectiveness of the GMCD; (b) to use an implementation science framework to understand barriers and facilitators to effective population coverage, provider implementation, and maintenance; (c) to conduct an economic evaluation of the GMCD.

Description:

Specific Aim 1: Assess the effectiveness of the GMCD intervention to improve developmental outcomes and nurturing care in India and Guatemala. The investigators will conduct a parallel-arm cluster randomized trial within rural CHW programs. In the primary effectiveness phase, children under 2 years old will receive the GMCD intervention or control for 12 months. Subsequently, control clusters will cross into the intervention, and continue an additional 12 months (total 24 study months). The primary developmental effectiveness outcome will be change in age-adjusted scores at 12 months on the Bayley Scales of Infant Development, 4th Edition BSID4) (3). The secondary nurturing care effectiveness outcome will be change in mean Home Observation for Measurement of the Environment (HOME) score at 12 months (4). Specific Aim 2: Assess barriers and facilitators to GMCD implementation using the RE-AIM evaluation framework (5). 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 (BSID4) and nurturing environment (HOME) [in Aim 1]; (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 [in Aim 3]; intent by decision makers and implementers to continue intervention. In addition, the investigators will conduct a sequential quantitative-->qualitative explanatory analysis, using interviews and focus groups with implementers from clusters with highest/lowest impact outcomes (BSID4/HOME) to explore institutional inner and outer setting and implementation processes associated with intervention success, using the Consolidated Framework for Implementation Research (CFIR). Specific Aim 3: Conduct an economic evaluation of the GMCD intervention. 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. This analysis will provide cost information to policymakers to help guide resource allocation decisions for ECD interventions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 624
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 24 Months

Eligibility

Inclusion Criteria:

• age 0-24 months at the time of enrollment visit
• receiving health services from frontline health workers of Maya Health Alliance (Guatemala), Mahatma Gandhi Institute (India) or their local partners

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

Related Conditions & MeSH terms

• Child Development

Intervention

Behavioral:
• International Guide for Monitoring Child Development
Monthly GMCD visits includes assessment of risk factors, open-ended exploration of caregiver concerns about development, assessment of functioning in seven developmental domains, and using mutual problem solving strategies to develop a nurturing care plan with the caregiver.

Locations

Country	Name	City	State
Guatemala	Wuqu' Kawoq	Tecpán Guatemala
India	Mahatma Gandhi Institute of Medical Sciences	Sevagram	Maharashtra

Sponsors (7)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Ankara University, Harvard Medical School (HMS and HSDM), Mahatma Gandhi Institute of Medical Sciences, Ummeed Child Development Center, University of Washington, Wuqu' Kawoq, Maya Health Alliance

Countries where clinical trial is conducted

Guatemala,  India, 

References & Publications (2)

Ertem IO, Dogan DG, Gok CG, Kizilates SU, Caliskan A, Atay G, Vatandas N, Karaaslan T, Baskan SG, Cicchetti DV. A guide for monitoring child development in low- and middle-income countries. Pediatrics. 2008 Mar;121(3):e581-9. doi: 10.1542/peds.2007-1771. — View Citation

Ertem IO, Krishnamurthy V, Mulaudzi MC, Sguassero Y, Balta H, Gulumser O, Bilik B, Srinivasan R, Johnson B, Gan G, Calvocoressi L, Shabanova V, Forsyth BWC. Similarities and differences in child development from birth to age 3 years by sex and across four countries: a cross-sectional, observational study. Lancet Glob Health. 2018 Mar;6(3):e279-e291. doi: 10.1016/S2214-109X(18)30003-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Composite Language Score at 24 months	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153	Change from 0 to 24 months
Other	Change in Composite Motor Score at 24 months	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154	Change from 0 to 24 months
Other	Change in Composite Cognitive Score at 24 months	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145	Change from 0 to 24 months
Other	Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score	Raw score range 0-45, higher scores better	Change from 0 to 24 months
Primary	Change in Composite Language Score at 12 months	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153	Change from 0 to 12 months
Primary	Change in Composite Motor Score at 12 months	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154	Change from 0 to 12 months
Primary	Change in Composite Cognitive Score at 12 months	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145	Change from 0 to 12 months
Secondary	Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score	Raw score range 0-45, higher scores better	Change from 0 to 12 months