The Pakistan Early Childhood Development Scale Up Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1489 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Early Child Development and Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

ECD Group

Stimulation and care for development (plus basic health and nutrition education and services)

Group Type EXPERIMENTAL

ECD

Intervention Type BEHAVIORAL

Enhanced Nutrition

Care for Nutrition: Enhanced education messages and Sprinkles for children aged 6-24 months (plus basic health and nutrition education and services)

Group Type EXPERIMENTAL

Enhanced Nutrition

Intervention Type BEHAVIORAL

ECD and Enhanced Nutrition

Stimulation and care for development and care for nutrition (plus basic health and nutrition education and services)

Group Type EXPERIMENTAL

ECD

Intervention Type BEHAVIORAL

Enhanced Nutrition

Intervention Type BEHAVIORAL

Interventions

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Control

Intervention Type BEHAVIORAL

ECD

Intervention Type BEHAVIORAL

Enhanced Nutrition

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.