SPRING Cluster Randomised Controlled Trial (SPRING)

• ClinicalTrials.gov Identifier: NCT02059863
• Recruitment Status: Unknown
• First Posted: February 11, 2014
• Last Update Posted: August 24, 2017
• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: University of Liverpool; University College, London; Human Development Research Foundation, Pakistan; Sangath
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine

Tracking Information

• First Submitted Date: February 10, 2014
• First Posted Date: February 11, 2014
• Last Update Posted Date: August 24, 2017
• Study Start Date: March 2014
• Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 10, 2014)

• infant mortality [ Time Frame: the first year of life ]
  the % of newborns who die during the first year of life
• stunting [ Time Frame: 18-24 months ]
  % children stunted, with stunting defined as below -2 standard deviations of height for age using the WHO growth standards
• child development [ Time Frame: 18-24 months of age ]
  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.
• maternal psychosocial distress/depression [ Time Frame: 6-12 months postpartum ]
  assessed using the 9 item Patient Health Questionnaire

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 10, 2014)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

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

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

Other Names:

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

Study Arms

• Experimental: 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

  Intervention: Behavioral: SPRING
• No Intervention: Control clusters
  access to routine maternal and child health services

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 10, 2014): 12000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2017
• Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Day to 24 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India, Pakistan

Administrative Information

• NCT Number: NCT02059863
• Other Study ID Numbers: EPNPBE2610; 093615 ( Other Grant/Funding Number: Wellcome Trust )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: London School of Hygiene and Tropical Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: London School of Hygiene and Tropical Medicine
• Original Study Sponsor: Same as current

Collaborators

• University of Liverpool
• University College, London
• Human Development Research Foundation, Pakistan
• Sangath

Investigators

• Principal Investigator: Betty Kirkwood, MSc, FMedSci; London School of Hygiene and Tropical Medicine

• PRS Account: London School of Hygiene and Tropical Medicine
• Verification Date: August 2017