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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American University of Beirut Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Vision
Ministry of Public Health, Lebanon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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