SPRING Cluster Randomised Controlled Trial

Study Overview
=================
Brief Summary
-----------------
A large number of children in developing countries lack access to known effective interventions. Almost 9 million die each year before reaching their fifth birthday, and over 200 million children who survive fail to achieve their full growth or developmental potential, trapping them in a cycle of continuing disadvantage. The goal of SPRING, Sustainable Programme Incorporating Nutrition and Games, is to develop an innovative approach to close this access gap, in two of the worst affected countries India and Pakistan, using community based agents. Extensive formative research will be carried out to help ensure that the content and approach of the SPRING intervention is feasible, acceptable and appropriately targeted. Findings will be reviewed at an intervention development workshop with local and international stakeholders and experts, and the agreed intervention piloted with a few community based agents and their supervisors. Cluster randomised controlled trials will be carried out in each setting to evaluate the impact of SPRING on child growth, development and survival. The programme will include process and economic evaluations to provide information on the total cost of the intervention and its cost effectiveness, as well as development of a framework with lessons learned for implementing SPRING in other settings.

Detailed Description
-----------------
The goal of SPRING, Sustainable Programme Incorporating Nutrition and Games, is to develop an innovative, feasible, affordable and sustainable community based approach that can achieve delivery at scale of known effective interventions that will maximise child development, growth and survival. The vision is to do this by working in close collaboration with government programmes in India and Pakistan, and modifying the approach, content and supervision of existing community based programmes to develop an innovative intervention package that Is designed from the outset to be feasible, affordable and appropriate for delivery at scale. Is delivered by low cost community based agents through home visits from pregnancy through the first 2 years of life, which promote evidence based newborn and child survival interventions use a problem solving and counselling approach, rather than the standard didactic approach, using techniques informed by evidence from the cognitive behaviour and interpersonal psychotherapy fields. teach care giving skills, such as early recognition of infant signals and capacity, enhancing mother baby interactions, providing stimulation for cognitive growth and development. support optimal infant and young child feeding practices. encourage participation of other family members, e.g. fathers and grandmothers. is informed by the Care for Development Package developed by the World Health Organization (WHO) and the United Nations International Emergency Children's Fund. Includes regular supervision, monitoring and evaluation to support the community based agents and ensure the quality of the intervention activities carried out. Includes a range of supporting activities developed to provide an enabling environment for mothers and families to carry out the interventions and skills promoted. These might include, for example, community group meetings, and sensitisation sessions with health staff. The specific objectives of SPRING are To test this intervention package through cluster randomised controlled trials in two settings, one in India and one in Pakistan, both with high rates of undernutrition and well established but somewhat different community based agent programmes. To evaluate the impact of the intervention on Infant mortality, child development and growth Maternal psychosocial distress. Coverage of key promoted interventions. To evaluate and monitor all aspects of the intervention process and implementation To cost the delivery of the intervention, and assess its cost effectiveness. To assess the effectiveness of the intervention in reducing inequities in trial outcomes.

Official Title
-----------------
SPRING (for the Millennium Development Goals): Sustainable Programme Incorporating Nutrition and Games (for Maximising Development, Growth and Survival)

Conditions
-----------------
Death, Child Development, Depression, Postpartum, Growth; Stunting, Nutritional

Intervention / Treatment
-----------------
* Behavioral: SPRING


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All liveborn babies whose mothers reside within the trial evaluation zones Exclusion Criteria: major congenital malformation maternal death in neonatal period

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPRING intervention clusters<br>SPRING package: Home visits by community based agents carried out from pregnancy to 2 years of age to encourage key behaviours to promote child growth, survival and development together with regular supervision PLUS access to routine maternal and child health services | Behavioral: SPRING<br>* SPRING package: Home visits by community based agents carried out from pregnancy to 2 years of age to encourage key behaviours to promote child growth, survival and development together with regular supervision<br>* Other names: India: Kilkaari (to be confirmed);|
| No Intervention: Control clusters<br>access to routine maternal and child health services | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infant mortality | the % of newborns who die during the first year of life | the first year of life | 
| stunting | % children stunted, with stunting defined as below -2 standard deviations of height for age using the WHO growth standards | 18-24 months | 
| child development | a range of psychometric outcome measures covering several domains including cognition, motor, language, and psychosocial development plus maternal-child interaction and quality of the home environment. | 18-24 months of age | 
| maternal psychosocial distress/depression | assessed using the 9 item Patient Health Questionnaire | 6-12 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % adopting key promoted behaviours |  | from pregnancy up to age 2 | 
| wasting | % children below -2 standard deviations for weight for height using the WHO growth standards. | 18-24 months of age | 
| underweight | % children below the -2 standard deviations for weight for age using the WHO growth standards. | 18-24 months of age | 
| age-specific infant mortality | % babies who die within the following periods after birth: <1 week, 1-3 weeks, 1st month,1-5 months, 6-11 months | during the first year of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cluster randomised trial, low and middle income countries, community based intervention, complex intervention