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The Pakistan Early Childhood Development Scale Up Trial (PEDS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Aga Khan University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
UNICEF
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00715936
First received: July 14, 2008
Last updated: July 6, 2011
Last verified: December 2010
  Purpose

The purpose of this study if to evaluate whether the integration of an early child stimulation and care for development package, alone or in combination with nutrition interventions, within a primary healthcare programme has beneficial outcomes for children up to 24 months of age in terms of motor, cognitive, communication and social functions in rural Pakistan.


Condition Intervention Phase
Growth & Development
Behavioral: Health Education
Behavioral: Early Child Development
Behavioral: Enhanced Nutrition Education
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 1 Study on the Integration of Early Childhood Interventions in a Primary Care Health Service in Sindh, Pakistan

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Early Child Development (Cognitive function, Fine and Gross Motor Skills, Communication and Language Skills, Social and Emotional behaviours) and Growth. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal knowledge and Practices for Care for Development [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Maternal depressive symptoms [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Child Anaemia Prevalence [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: July 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Standard community health worker support: Routine services for infants and young children delivered by the Lady Health Workers of the National Programme for Family Planning and Primary Healthcare
Behavioral: Health Education
Health Education on Hygiene, Primary Health Care.
Experimental: B
Standard community health worker support with early child development (stimulation and care for development)
Behavioral: Early Child Development
Responsive parenting education, responsive feeding, psychosocial stimulation activities.
Experimental: C
standard community health worker support with enhanced nutrition (education and Sprinkles)
Behavioral: Enhanced Nutrition Education
Nutrition messages for pregnant women, newborns and infants and delivery of Sprinkles for Infants 6-24months
Experimental: D
Standard community health worker support with early childhood development and enhanced nutrition packages
Behavioral: Early Child Development
Responsive parenting education, responsive feeding, psychosocial stimulation activities.
Behavioral: Enhanced Nutrition Education
Nutrition messages for pregnant women, newborns and infants and delivery of Sprinkles for Infants 6-24months

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 grassroot levels, reinforcement of health 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 stimulation interventions and the feasibility of scaling up an ECD strategy within the primary healthcare system of Pakistan.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
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)

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

Contacts
Contact: Mir MK Khan, MBA +92 21 34930051 ext 4385 asghar.ali@aku.edu
Contact: Aisha K Yousafzai, PhD. +92 21 3486 4733 aisha.yousafzai@aku.edu

Locations
Pakistan
Project Office, Dept of Paediatrics and Child Health, AKU Recruiting
Naushero, Sindh, Pakistan, 75300
Contact: Mir MK Khan, MBA    +92 21 4930051 ext 4385    asghar.ali@aku.edu   
Principal Investigator: Aisha K Yousafzai, PhD         
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

No publications provided

Responsible Party: Dr Zulfiqar A Bhutta, The 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: July 6, 2011
Health Authority: Pakistan: Ministry of Health

Keywords provided by Aga Khan University:
Early childhood development
Psychosocial stimulation
Care for child development

ClinicalTrials.gov processed this record on November 20, 2014