Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| UNICEF | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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) |
|
| ECD Group | Experimental | Stimulation and care for development (plus basic health and nutrition education and services) |
|
| Enhanced Nutrition | Experimental | Care for Nutrition: Enhanced education messages and Sprinkles for children aged 6-24 months (plus basic health and nutrition education and services) |
|
| ECD and Enhanced Nutrition | Experimental | Stimulation and care for development and care for nutrition (plus basic health and nutrition education and services) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Behavioral |
| ||
| ECD |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zulfiqar A Bhutta, MBBS, PhD | Aga Khan University | Study Chair |
| Aisha K Yousafzai, PhD | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Project Office, Dept of Paediatrics and Child Health, AKU | Naushero Feroze | Sindh | 75300 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27342433 | Derived | 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. | |
| 24947106 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Enhanced Nutrition | Behavioral |
|
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 |
| Derived |
| 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. |