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The Pakistan Early Childhood Development Scale Up Trial (PEDS)

A

Aga Khan University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Early Child Development and Growth

Treatments

Behavioral: ECD
Behavioral: Control
Behavioral: Enhanced Nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT00715936
993-PEDS/ERC-08

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,489 patients

Sex

All

Ages

1 day to 24 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

1,489 participants in 4 patient groups

Control
Active Comparator group
Description:
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)
Treatment:
Behavioral: Control
ECD Group
Experimental group
Description:
Stimulation and care for development (plus basic health and nutrition education and services)
Treatment:
Behavioral: ECD
Enhanced Nutrition
Experimental group
Description:
Care for Nutrition: Enhanced education messages and Sprinkles for children aged 6-24 months (plus basic health and nutrition education and services)
Treatment:
Behavioral: Enhanced Nutrition
ECD and Enhanced Nutrition
Experimental group
Description:
Stimulation and care for development and care for nutrition (plus basic health and nutrition education and services)
Treatment:
Behavioral: Enhanced Nutrition
Behavioral: ECD

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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