PEDS: The Pakistan Early Childhood Development Scale Up Trial

• Sponsor: Aga Khan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00715936
• Collaborator: UNICEF (Other)
• Enrollment: 1,489
• Location: 1
• Arms: 4
• Duration (Months): 32
• Patients Per Site Per Month: 46.5

Study Details

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
• 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: Jul 1, 2009
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

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 [24 months of child age]

   Cognitive, Language, Motor, Social-Emotional development

2. Child Growth [24 months of child age]

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

Secondary Outcome Measures

1. Caregiving Mediators: Maternal Psychological Distress (Depression) [Baseline, 6 months, 12 months, 18 months and 24 months of child age]

   Self-Reporting Questionnaire (SRQ)-20

2. Caregiving mediators: Caregiving Environment [6 months and 18 months of child age]

   Home Observation and Measurement of the Environment (HOME) Inventory

3. Caregiving Mediator: Mother/Child Interaction [12 months and 24 months of child age]

   Live observation

4. Caregiving Mediator: Care for Development [Baseline, 12 months and 24 months of child age]

   Knowledge and Practices Questionnaire (Maternal Report)

5. Caregiving Mediator: Feeding Practices [Baseline, 6 months, 12 months, 18 months and 24 months of child age]

   Maternal report of infant and young child feeding practices

6. Morbidity [Monthly report]

   Maternal recall

7. Anaemia Status [24 months child age]

   Haemoglobin assessment using HemoCue Assay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Aisha Khizar Yousafzai, Principal Investigator, Aga Khan University
• ClinicalTrials.gov Identifier: NCT00715936
• Other Study ID Numbers: 993-PEDS/ERC-08
• First Posted: Jul 15, 2008
• Last Update Posted: Jun 28, 2017
• Last Verified: Jun 1, 2017

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

Study Results

No Results Posted as of Jun 28, 2017