Clinical trial NCT00715936: The Pakistan Early Childhood Development Scale Up Trial
Official title: Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Early Child Development and Growth
Keywords: Integrated early child development, growth and health
Psychosocial stimulation
Care for child development
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: UNICEF
First posted: 2008-07-15
Enrollment: 1489
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Early Child Development
timeFrame: 24 months of child age
measure: Child Growth
timeFrame: 24 months of child age
Secondary outcomes:
measure: Caregiving Mediators: Maternal Psychological Distress (Depression)
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months of child age
measure: Caregiving mediators: Caregiving Environment
timeFrame: 6 months and 18 months of child age
measure: Caregiving Mediator: Mother/Child Interaction
timeFrame: 12 months and 24 months of child age
measure: Caregiving Mediator: Care for Development
timeFrame: Baseline, 12 months and 24 months of child age
measure: Caregiving Mediator: Feeding Practices
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months of child age
measure: Morbidity
timeFrame: Monthly report
measure: Anaemia Status
timeFrame: 24 months child age
Other outcomes:
Locations:
city: Naushero Feroze
country: Pakistan
facility: Project Office, Dept of Paediatrics and Child Health, AKU
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, MBBS, PhD
role: STUDY_CHAIR
affiliation: Aga Khan University
name: Aisha K Yousafzai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yousafzai AK, Obradovic J, Rasheed MA, Rizvi A, Portilla XA, Tirado-Strayer N, Siyal S, Memon U. Effects of responsive stimulation and nutrition interventions on children's development and growth at age 4 years in a disadvantaged population in Pakistan: a longitudinal follow-up of a cluster-randomised factorial effectiveness trial. Lancet Glob Health. 2016 Aug;4(8):e548-58. doi: 10.1016/S2214-109X(16)30100-0. Epub 2016 Jun 21.
citation: Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. Lancet. 2014 Oct 4;384(9950):1282-93. doi: 10.1016/S0140-6736(14)60455-4. Epub 2014 Jun 16.