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The Pakistan Early Childhood Development Scale Up Trial (PEDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00715936
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Early Child Development and Growth Behavioral: Control Behavioral: ECD Behavioral: Enhanced Nutrition Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1489 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (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
Study Start Date : July 2009
Primary Completion Date : March 2012
Study Completion Date : March 2012

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U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

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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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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