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Completed

NCT Number: NCT00715936

The Pakistan Early Childhood Development Scale Up Trial

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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Key information

Conditions

Early Child Development and Growth

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Project Office, Dept of Paediatrics and Child Health, AKU

Naushero Feroze, Sindh, 75300, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Behavioral

ECD

Behavioral

Enhanced Nutrition

Behavioral

Primary outcomes

  1. Early Child Development

    Time frame: 24 months of child age

    Cognitive, Language, Motor, Social-Emotional development

  2. Child Growth

    Time frame: 24 months of child age

    Length/Height, Weight, Mid Arm Circumference, Head Circumference

Secondary outcomes

  1. 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

  2. Caregiving mediators: Caregiving Environment

    Time frame: 6 months and 18 months of child age

    Home Observation and Measurement of the Environment (HOME) Inventory

  3. Caregiving Mediator: Mother/Child Interaction

    Time frame: 12 months and 24 months of child age

    Live observation

  4. Caregiving Mediator: Care for Development

    Time frame: Baseline, 12 months and 24 months of child age

    Knowledge and Practices Questionnaire (Maternal Report)

  5. 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

  6. Morbidity

    Time frame: Monthly report

    Maternal recall

  7. Anaemia Status

    Time frame: 24 months child age

    Haemoglobin assessment using HemoCue Assay

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • UNICEF

Registry information

Official study title

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

Acronym: PEDS

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 15, 2008
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.