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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545491
• Other study ID #: PED.DS.03
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 2017

Study information

• Verified date: July 2018
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Development

Intervention

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.
• Infant and Young Child feeding training by World Vision
Training on breastfeeding benefits, solid introduction and food safety

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (3)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Ministry of Public Health, Lebanon, World Vision

Country where clinical trial is conducted

Lebanon, 

References & Publications (2)

Anderson LM, Shinn C, Fullilove MT, Scrimshaw SC, Fielding JE, Normand J, Carande-Kulis VG; Task Force on Community Preventive Services. The effectiveness of early childhood development programs. A systematic review. Am J Prev Med. 2003 Apr;24(3 Suppl):32-46. Review. — View Citation

Bryanton J, Beck CT. Postnatal parental education for optimizing infant general health and parent-infant relationships. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004068. doi: 10.1002/14651858.CD004068.pub3. Review. Update in: Cochrane Database Syst Rev. 2013;11:CD004068. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enhancing child development. (developmental scores by BSID-III )	Children in the CCD-group will have better developmental scores by BSID-III compared to those in the WV- group.	one year
Secondary	Caregivers' knowledge (measured by pre and post assessement test)	Caregivers in the intervention group will have at least 25% improvement in the 12 items knowledge assessment questionnaire after the intervention.	one year
Secondary	Caregivers' behavior (measured by behavioral observation using predetermined checklist)	Caregivers' behavioral checklist scores (after the intervention) will be of at least 8 out of 10 for those in the intervention group.	one year