The Pakistan Early Childhood Development Scale Up Trial (PEDS)

June 27, 2017 updated by: Dr Aisha Khizar Yousafzai, Aga Khan University

Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1489

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Naushero Feroze, Sindh, Pakistan, 75300
        • Project Office, Dept of Paediatrics and Child Health, AKU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Child Development
Time Frame: 24 months of child age
Cognitive, Language, Motor, Social-Emotional development
24 months of child age
Child Growth
Time Frame: 24 months of child age
Length/Height, Weight, Mid Arm Circumference, Head Circumference
24 months of child age

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

UNICEF

Investigators

  • Principal Investigator: Aisha K Yousafzai, PhD, Aga Khan University
  • Study Chair: Zulfiqar A Bhutta, MBBS, PhD, The Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 993-PEDS/ERC-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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