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The Pakistan Early Childhood Development Scale Up Trial (PEDS)

This study has been completed.
Sponsor:
Collaborator:
UNICEF
Information provided by (Responsible Party):
Dr Aisha Khizar Yousafzai, Aga Khan University
ClinicalTrials.gov Identifier:
NCT00715936
First received: July 14, 2008
Last updated: June 27, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Early Child Development and Growth Behavioral: Control Behavioral: ECD Behavioral: Enhanced Nutrition Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan

Resource links provided by NLM:


Further study details as provided by Dr Aisha Khizar Yousafzai, Aga Khan University:

Primary Outcome Measures:
  • Early Child Development [ Time Frame: 24 months of child age ]
    Cognitive, Language, Motor, Social-Emotional development

  • Child Growth [ Time Frame: 24 months of child age ]
    Length/Height, Weight, Mid Arm Circumference, Head Circumference


Secondary Outcome Measures:
  • 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

  • Caregiving mediators: Caregiving Environment [ Time Frame: 6 months and 18 months of child age ]
    Home Observation and Measurement of the Environment (HOME) Inventory

  • Caregiving Mediator: Mother/Child Interaction [ Time Frame: 12 months and 24 months of child age ]
    Live observation

  • Caregiving Mediator: Care for Development [ Time Frame: Baseline, 12 months and 24 months of child age ]
    Knowledge and Practices Questionnaire (Maternal Report)

  • 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

  • Morbidity [ Time Frame: Monthly report ]
    Maternal recall

  • Anaemia Status [ Time Frame: 24 months child age ]
    Haemoglobin assessment using HemoCue Assay


Enrollment: 1489
Study Start Date: July 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715936

Locations
Pakistan
Project Office, Dept of Paediatrics and Child Health, AKU
Naushero Feroze, Sindh, Pakistan, 75300
Sponsors and Collaborators
Aga Khan University
UNICEF
Investigators
Study Chair: Zulfiqar A Bhutta, MBBS, PhD The Aga Khan University
Principal Investigator: Aisha K Yousafzai, PhD Aga Khan University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Aisha Khizar Yousafzai, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT00715936     History of Changes
Other Study ID Numbers: 993-PEDS/ERC-08
Study First Received: July 14, 2008
Last Updated: June 27, 2017

Keywords provided by Dr Aisha Khizar Yousafzai, Aga Khan University:
Integrated early child development, growth and health
Psychosocial stimulation
Care for child development

ClinicalTrials.gov processed this record on July 19, 2017