- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02534597
National Evaluation of Quality of Childcare (ENCCI)
National Evaluation of Quality of Childcare (ENCCI)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Whole Child International (WCI) is a U.S.-based non-governmental organization. Its focus is on improving the caregiving environments for vulnerable children by effecting changes within child care centers and orphanages.
This evaluation will assess the impact of an educational training and technical assistance program offered by WCI in collaboration with the El Salvadoran government. The program consists of a series of educational trainings (for local government officials, directors of childcare and residential centers, and center caregivers) and technical assistance including infrastructural changes within centers.
To evaluate this intervention, a longitudinal, randomized controlled trial will be used to assign participating centers to one of seven treatment arms that will receive different components of the intervention. A community comparison cohort will also be enrolled to identify selection effects as well as local norms and standards. The central research question is, "Does providing training for institution providers and caregivers improve child outcomes?"
Ethnographic research will also explore local cultural norms regarding child caregiving, and seek to understand how the intervention is received within communities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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San Salvador, El Salvador
- Whole Child International
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children between the ages of 6 months-4 years old at baseline, who are currently attending government-run childcare centers in El Salvador, will be eligible for enrollment in this study. One parent/guardian and center caregiver for an enrolled child will also complete assessments.
- In the comparison group, for every 5th center-attending child enrolled, the nearest neighboring child between the ages of 6 months and 4 years at enrollment, and who does not attend the center, will be eligible for enrollment. One parent/guardian of the comparison child will also complete assessments.
Exclusion Criteria:
- Children with known disabilities, who are unlikely to show developmental changes over time, may be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pctm
Receives the earliest Promotores training, followed by direct caregiver training, materials support, and technical assistance.
|
|
Experimental: p_ctm
Receives the earliest Promotores training, followed by delayed caregiver training, delayed materials support, and delayed technical assistance.
|
|
Experimental: _pmt
Receives the delayed Promotores training, followed by receipt of materials support and technical assistance.
|
|
Experimental: _p_mt
Receives the delayed Promotores training, followed by delayed receipt of materials support and technical assistance.
|
|
Experimental: _pct
Receives the delayed Promotores training, followed by caregiver training and technical assistance.
|
|
Experimental: _p_ct
Receives the delayed Promotores training, followed by delayed caregiver training and technical assistance.
|
|
Experimental: _pt
Receives the delayed Promotores training, followed by technical assistance.
|
|
Experimental: _p_t
Receives the delayed Promotores training, followed by delayed technical assistance.
|
|
Experimental: _pc
Receives the delayed Promotores training, followed by a full caregiver training only.
|
|
Experimental: _p_c
Receives the delayed Promotores training, followed by delayed caregiver training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's developmental milestone achievement as measured by the Battelle Developmental Inventory, Second Edition (BDI-2).
Time Frame: Four years
|
The BDI-2 Developmental Quotient has a mean of 100, standard deviation of 15, score range 40-160.
|
Four years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan Ostermann, PhD, Associate Research Professor
- Principal Investigator: Kathryn Whetten, PhD, Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C0682
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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