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The Pakistan Early Childhood Development Scale Up Trial

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00715936
Acronym
PEDS
Enrollment
1489
Registered
2008-07-15
Start date
2009-07-31
Completion date
2012-03-31
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Child Development and Growth

Keywords

Integrated early child development, growth and health, Psychosocial stimulation, Care for child development

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.

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.

Interventions

BEHAVIORALControl
BEHAVIORALECD
BEHAVIORALEnhanced Nutrition

Sponsors

UNICEF
CollaboratorOTHER
Aga Khan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 24 Months
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

Design outcomes

Primary

MeasureTime frameDescription
Early Child Development24 months of child ageCognitive, Language, Motor, Social-Emotional development
Child Growth24 months of child ageLength/Height, Weight, Mid Arm Circumference, Head Circumference

Secondary

MeasureTime frameDescription
Caregiving Mediator: Mother/Child Interaction12 months and 24 months of child ageLive observation
Caregiving Mediator: Care for DevelopmentBaseline, 12 months and 24 months of child ageKnowledge and Practices Questionnaire (Maternal Report)
Caregiving Mediators: Maternal Psychological Distress (Depression)Baseline, 6 months, 12 months, 18 months and 24 months of child ageSelf-Reporting Questionnaire (SRQ)-20
MorbidityMonthly reportMaternal recall
Anaemia Status24 months child ageHaemoglobin assessment using HemoCue Assay
Caregiving Mediator: Feeding PracticesBaseline, 6 months, 12 months, 18 months and 24 months of child ageMaternal report of infant and young child feeding practices
Caregiving mediators: Caregiving Environment6 months and 18 months of child ageHome Observation and Measurement of the Environment (HOME) Inventory

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026