A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development
NCT ID: NCT04665297
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
624 participants
INTERVENTIONAL
2023-01-17
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention arm
Subjects from intervention clusters will receive the GMCD intervention, delivered in monthly visits to the home by frontline health workers, for 24 months. 0-12 months represents the primary effectiveness study, and 12-24 months a secondary maintenance study.
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.
Control Arm
Subjects in control clusters will continue to receive usual care from their frontline health workers. After 12 months (primary effectiveness study) control will cross into the intervention for months 12-24.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* receiving health services from frontline health workers of Maya Health Alliance (Guatemala), Mahatma Gandhi Institute (India) or their local partners
Exclusion Criteria
* children whose caregivers do not provide informed consent for the study
0 Months
24 Months
ALL
No
Sponsors
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Mahatma Gandhi Institute of Medical Sciences
OTHER
Ummeed Child Development Center
UNKNOWN
Ankara University
OTHER
Wuqu' Kawoq, Maya Health Alliance
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
University of Washington
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Peter J. Rohloff, M.D.,Ph.D.
Assistant Professor/Associate Physician
Principal Investigators
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Peter Rohloff
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor/Associate Physician
Locations
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Wuqu' Kawoq
Tecpán Guatemala, , Guatemala
Mahatma Gandhi Institute of Medical Sciences
Sevāgrām, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Peter Rohloff
Role: primary
Subodh Gupta
Role: primary
References
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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.
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.
Raut A, Mustafayev R, Srinivasan R, Chary A, Ertem I, Grazioso MDP, Gupta S, Krishnamurthy V, Lu C, Maliye C, Miller AC, Wagenaar BH, Rohloff P. Hybrid type 1 effectiveness/implementation trial of the international Guide for Monitoring Child Development: protocol for a cluster-randomised controlled trial. BMJ Paediatr Open. 2021 Sep 15;5(1):e001254. doi: 10.1136/bmjpo-2021-001254. eCollection 2021.
Other Identifiers
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2020P002143
Identifier Type: -
Identifier Source: org_study_id