SPRING Cluster Randomised Controlled Trial

Child Development Clinical Trial

— SPRING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02059863
• Other study ID #: EPNPBE2610
• Secondary ID: 093615
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2014
• Last updated: August 23, 2017
• Start date: March 2014
• Est. completion date: October 2017

Study information

• Verified date: August 2017
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

• All liveborn babies whose mothers reside within the trial evaluation zones

Exclusion Criteria:

• major congenital malformation

• maternal death in neonatal period

Related Conditions & MeSH terms

• Child Development
• Death
• Depression, Postpartum
• Growth; Stunting, Nutritional

Intervention

Behavioral:
• SPRING
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

Locations

Country	Name	City	State
India	Sangath: Haryana field site	Porvorim	Goa
Pakistan	Human Development Research Foundation: Rawalpindi field site	Islamabad	Punjab

Sponsors (5)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Human Development Research Foundation, Pakistan, Sangath, University College, London, University of Liverpool

Countries where clinical trial is conducted

India,  Pakistan, 

References & Publications (2)

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;1308:204-17. doi: 10.1111/nyas.12326. Epub 2014 Jan 6. — View 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;1308:107-17. doi: 10.1111/nyas.12339. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infant mortality	the % of newborns who die during the first year of life	the first year of life
Primary	stunting	% children stunted, with stunting defined as below -2 standard deviations of height for age using the WHO growth standards	18-24 months
Primary	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
Primary	maternal psychosocial distress/depression	assessed using the 9 item Patient Health Questionnaire	6-12 months postpartum
Secondary	% adopting key promoted behaviours		from pregnancy up to age 2
Secondary	wasting	% children below -2 standard deviations for weight for height using the WHO growth standards.	18-24 months of age
Secondary	underweight	% children below the -2 standard deviations for weight for age using the WHO growth standards.	18-24 months of age
Secondary	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