The Pakistan Early Childhood Development Scale Up Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Early Child Development and Growth

Intervention / Treatment
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* Behavioral: Control
* Behavioral: ECD
* Behavioral: Enhanced Nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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<br> <br> |
| Experimental: ECD Group<br>Stimulation and care for development (plus basic health and nutrition education and services) | Behavioral: ECD<br> <br> |
| Experimental: Enhanced Nutrition<br>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<br> <br> |
| Experimental: ECD and Enhanced Nutrition<br>Stimulation and care for development and care for nutrition (plus basic health and nutrition education and services) | Behavioral: ECD<br> <br> Behavioral: Enhanced Nutrition<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Child Development | Cognitive, Language, Motor, Social-Emotional development | 24 months of child age | 
| Child Growth | Length/Height, Weight, Mid Arm Circumference, Head Circumference | 24 months of child age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiving Mediators: Maternal Psychological Distress (Depression) | Self-Reporting Questionnaire (SRQ)-20 | Baseline, 6 months, 12 months, 18 months and 24 months of child age | 
| Caregiving mediators: Caregiving Environment | Home Observation and Measurement of the Environment (HOME) Inventory | 6 months and 18 months of child age | 
| Caregiving Mediator: Mother/Child Interaction | Live observation | 12 months and 24 months of child age | 
| Caregiving Mediator: Care for Development | Knowledge and Practices Questionnaire (Maternal Report) | Baseline, 12 months and 24 months of child age | 
| Caregiving Mediator: Feeding Practices | Maternal report of infant and young child feeding practices | Baseline, 6 months, 12 months, 18 months and 24 months of child age | 
| Morbidity | Maternal recall | Monthly report | 
| Anaemia Status | Haemoglobin assessment using HemoCue Assay | 24 months child age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Integrated early child development, growth and health, Psychosocial stimulation, Care for child development