The Pakistan Early Childhood Development Scale Up Trial

Phase 2

Completed

• Conditions: Early Child Development and Growth
• Interventions: Behavioral: ECD; Behavioral: Control; Behavioral: Enhanced Nutrition

• Registration Number: NCT00715936
• Lead Sponsor: Aga Khan University

Brief Summary

The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial outcomes on child development (cognitive, language, motor and social emotional development) and child growth.

Detailed Description

In Pakistan, the "National Program for Family Planning and Primary Healthcare" delivers maternal and child health and nutrition services in rural and remote areas of Pakistan through community-based Lady Health Workers. The strengths of the programme include provision of services at grassroots levels, reinforcement of health and basic nutrition messages and community acceptability. Given, the growing recognition that optimal early child development (ECD) also requires the integration of psychosocial care; the PEDS-Trial has been proposed to evaluate the benefits of the addition of 'stimulation and care for development' interventions and the feasibility of scaling up an ECD strategy within the community healthcare system of Pakistan.

Study Timeline

• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-15
• Study Start: 2009-07
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1489

Inclusion Criteria

• All children born in the defined geographical area of study during the study enrollment period will be eligible for the study along with their primary care giver (mother). Infant must be 1d-2.5m of age at time of enrolment.

Exclusion Criteria

• Children born with profound severe disabilities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ECD Group	ECD	Stimulation and care for development (plus basic health and nutrition education and services)
Control	Control	Routine services for infants and young children delivered by the Lady Health Workers of the National Programme for Family Planning and Primary Healthcare (Basic Health and Nutrition Education and Services)
ECD and Enhanced Nutrition	ECD	Stimulation and care for development and care for nutrition (plus basic health and nutrition education and services)
Enhanced Nutrition	Enhanced Nutrition	Care for Nutrition: Enhanced education messages and Sprinkles for children aged 6-24 months (plus basic health and nutrition education and services)
ECD and Enhanced Nutrition	Enhanced Nutrition	Stimulation and care for development and care for nutrition (plus basic health and nutrition education and services)

Primary Outcome Measures

Name	Time	Method
Early Child Development	24 months of child age	Cognitive, Language, Motor, Social-Emotional development
Child Growth	24 months of child age	Length/Height, Weight, Mid Arm Circumference, Head Circumference

Secondary Outcome Measures

Name	Time	Method
Caregiving Mediators: Maternal Psychological Distress (Depression)	Baseline, 6 months, 12 months, 18 months and 24 months of child age	Self-Reporting Questionnaire (SRQ)-20
Caregiving mediators: Caregiving Environment	6 months and 18 months of child age	Home Observation and Measurement of the Environment (HOME) Inventory
Caregiving Mediator: Feeding Practices	Baseline, 6 months, 12 months, 18 months and 24 months of child age	Maternal report of infant and young child feeding practices
Caregiving Mediator: Care for Development	Baseline, 12 months and 24 months of child age	Knowledge and Practices Questionnaire (Maternal Report)
Morbidity	Monthly report	Maternal recall
Anaemia Status	24 months child age	Haemoglobin assessment using HemoCue Assay
Caregiving Mediator: Mother/Child Interaction	12 months and 24 months of child age	Live observation

Trial Locations

Locations (1)

Project Office, Dept of Paediatrics and Child Health, AKU; 🇵🇰 Naushero Feroze, Sindh, Pakistan