Clinical trial NCT04665297: A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Development
Keywords: Guatemala
India
Early Child Development
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Mahatma Gandhi Institute of Medical Sciences
name: Ummeed Child Development Center
name: Ankara University
name: Wuqu' Kawoq, Maya Health Alliance
name: Harvard Medical School (HMS and HSDM)
name: University of Washington
First posted: 2020-12-11
Enrollment: 624
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nonblinded, two-arm cluster randomized controlled trial for 12 months. At 12 months, control arm crosses into the intervention, and both arms receive the intervention for an additional 12 months (total of 24 months)
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Composite Language Score at 12 months
timeFrame: Change from 0 to 12 months
measure: Change in Composite Motor Score at 12 months
timeFrame: Change from 0 to 12 months
measure: Change in Composite Cognitive Score at 12 months
timeFrame: Change from 0 to 12 months
Secondary outcomes:
measure: Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score
timeFrame: Change from 0 to 12 months
Other outcomes:
measure: Change in Composite Language Score at 24 months
timeFrame: Change from 0 to 24 months
measure: Change in Composite Motor Score at 24 months
timeFrame: Change from 0 to 24 months
measure: Change in Composite Cognitive Score at 24 months
timeFrame: Change from 0 to 24 months
measure: Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score
timeFrame: Change from 0 to 24 months
Locations:
city: Tecpán Guatemala
country: Guatemala
facility: Wuqu' Kawoq
city: Sevagram
country: India
facility: Mahatma Gandhi Institute of Medical Sciences
state: Maharashtra
Study officials:
affiliation: Assistant Professor/Associate Physician
name: Peter Rohloff
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.