SPRING Cluster Randomised Controlled Trial

NCT ID: NCT02059863

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

SPRING intervention clusters

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

Group Type: EXPERIMENTAL

SPRING

Intervention Type: BEHAVIORAL

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

Control clusters

access to routine maternal and child health services

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Pakistan: Roshan Kal; India: Kilkaari (to be confirmed)

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liverpool

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

Human Development Research Foundation, Pakistan

OTHER

Sponsor Role: collaborator

Sangath

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betty Kirkwood, MSc, FMedSci

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Sangath: Haryana field site

Porvorim, Goa, India

Site Status: RECRUITING

Human Development Research Foundation: Rawalpindi field site

Islamabad, Punjab Province, Pakistan

Site Status: NOT_YET_RECRUITING

Countries

India; Pakistan

Facility Contacts

Gauri Divan, MD

Role: primary

gauridivan@gmail.com

+919881722551

Siham Sikander, MD, PhD

Role: primary

siham.sikander@hdrfoundation.org

+92512656172

References

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.

Reference Type: BACKGROUND

PMID: 24571213 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24392960 (View on PubMed)

Other Identifiers

093615

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EPNPBE2610

Identifier Type: -

Identifier Source: org_study_id