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

NCT02545491 | Completed DMC

• 1 other identifier: PED.DS.03
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Development

Keywords

CCD; Child development; daycare; caregiver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Caregivers' knowledge (measured by pre and post assessement test)

  one year

• Caregivers' behavior (measured by behavioral observation using predetermined checklist)

  one year

Study Arms (2)

Care for Child Development group

EXPERIMENTAL

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; Behavioral: Infant and Young Child feeding training by World Vision

World Vision Lebanon training group

ACTIVE COMPARATOR

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

Interventions

Care for Child Development (CCD) program BEHAVIORAL

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.

Care for Child Development group

Infant and Young Child feeding training by World Vision BEHAVIORAL

Training on breastfeeding benefits, solid introduction and food safety

Care for Child Development group; World Vision Lebanon training group

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• World Vision: collaborator
• Ministry of Public Health, Lebanon: collaborator

Study Sites (1)

American University of Beirut

Beirut, 1107 2020, Lebanon

Location

Related 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. doi: 10.1016/s0749-3797(02)00655-4.

  PMID: 12668197 BACKGROUND

• 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.

  PMID: 20091558 BACKGROUND

MeSH Terms

Interventions

Child Development

Intervention Hierarchy (Ancestors)

Human Development; Growth and Development; Physiological Phenomena

Study Officials

• Durriyah Sinno, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Clinical Pediatrics, MD FAAP

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 10, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

LE (1)