Clinical trial NCT02059863: SPRING Cluster Randomised Controlled Trial
Official title: SPRING (for the Millennium Development Goals): Sustainable Programme Incorporating Nutrition and Games (for Maximising Development, Growth and Survival)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Growth; Stunting, Nutritional
Child Development
Depression, Postpartum
Death
Keywords: cluster randomised trial
low and middle income countries
community based intervention
complex intervention
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: University of Liverpool
name: University College, London
name: Human Development Research Foundation, Pakistan
name: Sangath
First posted: 2014-02-11
Enrollment: 12000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

1. 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.
2. To evaluate the impact of the intervention on Infant mortality, child development and growth Maternal psychosocial distress. Coverage of key promoted interventions.
3. To evaluate and monitor all aspects of the intervention process and implementation
4. To cost the delivery of the intervention, and assess its cost effectiveness.
5. To assess the effectiveness of the intervention in reducing inequities in trial outcomes.

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

Primary outcomes:
measure: infant mortality
timeFrame: the first year of life
measure: stunting
timeFrame: 18-24 months
measure: child development
timeFrame: 18-24 months of age
measure: maternal psychosocial distress/depression
timeFrame: 6-12 months postpartum
Secondary outcomes:
measure: % adopting key promoted behaviours
timeFrame: from pregnancy up to age 2
measure: wasting
timeFrame: 18-24 months of age
measure: underweight
timeFrame: 18-24 months of age
measure: age-specific infant mortality
timeFrame: during the first year of life
Other outcomes:
Locations:
city: Porvorim
country: India
facility: Sangath: Haryana field site
state: Goa
city: Islamabad
country: Pakistan
facility: Human Development Research Foundation: Rawalpindi field site
state: Punjab
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Betty Kirkwood, MSc, FMedSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zafar S, Sikander S, Haq Z, Hill Z, Lingam R, Skordis-Worrall J, Hafeez A, Kirkwood B, Rahman A. Integrating maternal psychosocial well-being into a child-development intervention: the five-pillars approach. Ann N Y Acad Sci. 2014 Jan;1308:107-117. doi: 10.1111/nyas.12339.
citation: Lingam R, Gupta P, Zafar S, Hill Z, Yousafzai A, Iyengar S, Sikander S, Haq ZU, Mehta S, Skordis-Worrel J, Rahman A, Kirkwood B. Understanding care and feeding practices: building blocks for a sustainable intervention in India and Pakistan. Ann N Y Acad Sci. 2014 Jan;1308:204-217. doi: 10.1111/nyas.12326. Epub 2014 Jan 6.