Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665297
Recruitment Status : Not yet recruiting
First Posted : December 11, 2020
Last Update Posted : July 21, 2022
Sponsor:
Collaborators:
Mahatma Gandhi Institute of Medical Sciences
Ummeed Child Development Center
Ankara University
Wuqu' Kawoq, Maya Health Alliance
Harvard Medical School (HMS and HSDM)
University of Washington
Information provided by (Responsible Party):
Peter J. Rohloff, M.D.,Ph.D., Brigham and Women's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Child Development Behavioral: International Guide for Monitoring Child Development Not Applicable

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, 3rd Edition BSID3) (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 (BSID3) 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 (BSID3/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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Masking Description: Given nature of study, blinding is not feasible.
Primary Purpose: Prevention
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
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : April 30, 2026
Estimated Study Completion Date : April 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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.
 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.
No Intervention: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Composite Language Score at 12 months [ Time Frame: Change from 0 to 12 months ]
    Using the Bayley Scales of Infant Development, 3rd Edition (BSID3), higher scores better, scale range 47-153

  2. Change in Composite Motor Score at 12 months [ Time Frame: Change from 0 to 12 months ]
    Using the Bayley Scales of Infant Development, 3rd Edition (BSID3), higher scores better, scale range 46-154

  3. Change in Composite Cognitive Score at 12 months [ Time Frame: Change from 0 to 12 months ]
    Using the Bayley Scales of Infant Development, 3rd Edition (BSID3), higher scores better, scale range 55-145


Secondary Outcome Measures :
  1. Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score [ Time Frame: Change from 0 to 12 months ]
    Raw score range 0-45, higher scores better


Other Outcome Measures:
  1. Change in Composite Language Score at 24 months [ Time Frame: Change from 0 to 24 months ]
    Using the Bayley Scales of Infant Development, 3rd Edition (BSID3), higher scores better, scale range 47-153

  2. Change in Composite Motor Score at 24 months [ Time Frame: Change from 0 to 24 months ]
    Using the Bayley Scales of Infant Development, 3rd Edition (BSID3), higher scores better, scale range 46-154

  3. Change in Composite Cognitive Score at 24 months [ Time Frame: Change from 0 to 24 months ]
    Using the Bayley Scales of Infant Development, 3rd Edition (BSID3), higher scores better, scale range 55-145

  4. Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score [ Time Frame: Change from 0 to 24 months ]
    Raw score range 0-45, higher scores better


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   0 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665297


Contacts
Layout table for location contacts
Contact: Peter Rohloff 617-447-3034 prohloff@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
Mahatma Gandhi Institute of Medical Sciences
Ummeed Child Development Center
Ankara University
Wuqu' Kawoq, Maya Health Alliance
Harvard Medical School (HMS and HSDM)
University of Washington
Investigators
Layout table for investigator information
Principal Investigator: Peter Rohloff Assistant Professor/Associate Physician
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Peter J. Rohloff, M.D.,Ph.D., Assistant Professor/Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04665297    
Other Study ID Numbers: 2020P002143
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will deposit the above data in the Harvard Dataverse (https://dataverse.harvard.edu/) or another suitable public data repository, and it will be freely available there for any researcher wishing to perform secondary analysis, confirmation of primary study findings, or meta-analysis who adheres to the existing policy and procedures of the repository.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: We will submit data sets to the repository no later than 3 years after completion of final patient follow-up, or 2 years after the publication of the main study paper, whichever comes first.
Access Criteria: Publically available

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter J. Rohloff, M.D.,Ph.D., Brigham and Women's Hospital:
Guatemala
India
Early Child Development