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National Evaluation of Quality of Childcare (ENCCI)

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ClinicalTrials.gov Identifier: NCT02534597
Recruitment Status : Unknown
Verified September 2017 by Jan Ostermann, Duke University.
Recruitment status was:  Enrolling by invitation
First Posted : August 27, 2015
Last Update Posted : September 5, 2017
Sponsor:
Collaborators:
Whole Child International
University of South Carolina
University of Pittsburgh
Information provided by (Responsible Party):
Jan Ostermann, Duke University

Brief Summary:
This evaluation seeks to assess the impact of a training program on childcare center environments and child/caregiver wellbeing in El Salvador. Through a longitudinal, randomized control trial, over 200 childcare centers participating in the program will be assigned to various treatment arms receiving different components of the program. A community comparison cohort will also be enrolled.

Condition or disease Intervention/treatment Phase
Child Rearing Mental Health Wellness 1 Health Behavior Behavioral: Promotores Training Behavioral: Delayed Promotores training Behavioral: Caregiver training Behavioral: Delayed caregiver training Behavioral: Materials support Behavioral: Delayed materials support Behavioral: Technical assistance Behavioral: Delayed technical assistance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1698 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: National Evaluation of Quality of Childcare (ENCCI)
Study Start Date : August 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pctm
Receives the earliest Promotores training, followed by direct caregiver training, materials support, and technical assistance.
Behavioral: Promotores Training
Behavioral: Caregiver training
Behavioral: Materials support
Behavioral: Technical assistance
Experimental: p_ctm
Receives the earliest Promotores training, followed by delayed caregiver training, delayed materials support, and delayed technical assistance.
Behavioral: Promotores Training
Behavioral: Delayed caregiver training
Behavioral: Delayed materials support
Behavioral: Delayed technical assistance
Experimental: _pmt
Receives the delayed Promotores training, followed by receipt of materials support and technical assistance.
Behavioral: Delayed Promotores training
Behavioral: Materials support
Behavioral: Technical assistance
Experimental: _p_mt
Receives the delayed Promotores training, followed by delayed receipt of materials support and technical assistance.
Behavioral: Delayed Promotores training
Behavioral: Delayed materials support
Behavioral: Delayed technical assistance
Experimental: _pct
Receives the delayed Promotores training, followed by caregiver training and technical assistance.
Behavioral: Delayed Promotores training
Behavioral: Caregiver training
Behavioral: Technical assistance
Experimental: _p_ct
Receives the delayed Promotores training, followed by delayed caregiver training and technical assistance.
Behavioral: Delayed Promotores training
Behavioral: Delayed caregiver training
Behavioral: Delayed technical assistance
Experimental: _pt
Receives the delayed Promotores training, followed by technical assistance.
Behavioral: Delayed Promotores training
Behavioral: Technical assistance
Experimental: _p_t
Receives the delayed Promotores training, followed by delayed technical assistance.
Behavioral: Delayed Promotores training
Behavioral: Delayed technical assistance
Experimental: _pc
Receives the delayed Promotores training, followed by a full caregiver training only.
Behavioral: Delayed Promotores training
Behavioral: Caregiver training
Experimental: _p_c
Receives the delayed Promotores training, followed by delayed caregiver training.
Behavioral: Delayed Promotores training
Behavioral: Delayed caregiver training



Primary Outcome Measures :
  1. 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.



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.


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Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02534597


Locations
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El Salvador
Whole Child International
San Salvador, El Salvador
Sponsors and Collaborators
Duke University
Whole Child International
University of South Carolina
University of Pittsburgh
Investigators
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Principal Investigator: Jan Ostermann, PhD Associate Research Professor
Principal Investigator: Kathryn Whetten, PhD Professor
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Responsible Party: Jan Ostermann, Principal Investigator, Duke University
ClinicalTrials.gov Identifier: NCT02534597    
Other Study ID Numbers: C0682
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017