Implementation and Adoption of Care for Child Development in Day Care Centers

July 4, 2018 updated by: Lama Charafeddine, American University of Beirut Medical Center

Implementation of Care for Child Development and Implications on Early Childhood Development: A Pilot Study in Lebanon

Background: Responsive stimulation and/or enhanced nutrition interventions delivered to children through health programs shows improved cognitive, language, and motor, and the social-emotional status. This could benefit young children in Lebanon and worldwide to improve their developmental potential.

Aim: This study aims to implement Care for Child Development (CCD) intervention for children aged 0-3 years within a supportive environment in Day Care Centers and to investigate its effectiveness on early child development.

Methodology: CCD program will be implemented in 10 randomly selected daycare centers in Lebanon where three providers in each center will be trained (CCD-group). Another group of 10 day care centers will serve as controls (WV-group). 228 Children in each group will receive either early stimulation based on CCD and education from the World Vision Infant and Young Child Feeding (WV-IYCF) project (CCD-group) or education from the WV-IYCF project (WV-group). Caregivers' knowledge and behaviors will be assessed before and after the intervention using a predetermined questionnaire and behavioral checklist. Early child development will be assessed using Ages and Stages Questionnaire-3 (ASQ-3) and Bayley Scale for infant Development (BSID-III).

Expected Outcome: Implementation of CCD program in day care centers will be feasible and will lead to enhanced early child development. This study will serve as a prototype for program implementation throughout the country and the region.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims at testing the implementation and effectiveness of the CCD program on early child development in selected day care centers in Beirut. It is being conducted in collaboration with World Vision and the Lebanese Ministry of Public Health.

Day Care centers are invited by the ministry of health to participate in this proposed study.

After securing the approval of the Center's director, caregivers working at those day care centers are being invited to participate in this study.

Those caregivers who agree to participate will receive either training on the CCD program AND early child nutrition from World Vision (Infant & Young Child Feeding Project WV-IYCFP) (Intervention group) or training on early child nutrition from WV-IYCFP only (control group).

The Care for Child Development (CCD) Program developed by World Health Organization (WHO) /UNICEF provides caregivers with recommendations for stimulating child development through play and communication activities.

WV-IYCFP provides activities related to raising awareness on breastfeeding and complementary food introduction to optimize child nutrition.

The Intervention group (CCD-Group) consists of 10 day care centers chosen randomly. Three caregivers from each center (total 30 caregivers) will attend a day-and-a-half CCD training at the Center of Excellence for Early Child Development at AUBMC. In addition, they will participate in the World Vision activities related to the Infant & Young Child Feeding Project (WV-IYCFP). The day care centers in this group will receive a manual including early child development concepts and techniques to be used as a reference.

The Control group (WV-Group) consists of 10 day care centers chosen randomly. Three caregivers from each center (total 30 caregivers) will participate in activities related to the WV-IYCFP.

Caregivers in both groups will be asked to take a knowledge assessment questionnaire on child development before and after each training, then at 6months and 12 months after the intervention.

In both groups, caregivers' behavior in early child stimulation will be assessed before and after the trainings. Caregivers will be observed delivering child care as per each center's routine; their behavior will be assessed using a predetermined behavioral check list developed based on the CCD program.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon, 1107 2020
        • American University of Beirut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 0 to 3 years registered in the selected daycare centers.

Exclusion Criteria:

  • Children diagnosed with medical conditions that might affect developmental assessment, or who are older than the specified ages will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Care for Child Development group
Training of caregivers on the Care for Child Development (CCD) program, in addition to the training on Infant and Young Child feeding program by World Vision.
Behavioral: Care for Child Development (CCD) program
The Care for Child Development (CCD) Program developed by World Health Organization (WHO) /UNICEF provides recommendations for stimulating child development through play and communication activities.
Behavioral: Infant and Young Child feeding training by World Vision
Training on breastfeeding benefits, solid introduction and food safety
Active Comparator: World Vision Lebanon training group
caregivers will receive training in Infant and Young Child Feeding (WV-IYCF) offered by World Vision.
Behavioral: Infant and Young Child feeding training by World Vision
Training on breastfeeding benefits, solid introduction and food safety

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enhancing child development. (developmental scores by BSID-III )
Time Frame: one year
Children in the CCD-group will have better developmental scores by BSID-III compared to those in the WV- group.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregivers' knowledge (measured by pre and post assessement test)
Time Frame: one year
Caregivers in the intervention group will have at least 25% improvement in the 12 items knowledge assessment questionnaire after the intervention.
one year
Caregivers' behavior (measured by behavioral observation using predetermined checklist)
Time Frame: one year
Caregivers' behavioral checklist scores (after the intervention) will be of at least 8 out of 10 for those in the intervention group.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Collaborators

World Vision
Ministry of Public Health, Lebanon

Investigators

  • Principal Investigator: Durriyah Sinno, MD, American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

September 8, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PED.DS.03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Child Development

Clinical Trials on Care for Child Development (CCD) program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe