Leicester Clinical Trials Unit

Surviving Crying Trial

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Contact

Email: survivingcrying@leicester.ac.uk

Key Information

Trial Title

Surviving Crying

Cluster Randomised Controlled Trial of a Service to Support the Mental Health and Coping of Parents with Excessively Crying Infants 

Chief Investigator 

Professor Jayne Brown

Sponsor

De Montfort University 

Funder

NIHR HTA 

Trial Registration Number

TBC

Summary

Around about a fifth of infants cry a lot without an apparent reason during the first
four months after they are born. This ‘excessive’ infant crying is often called ‘colic’ and blamed on
Indigestion. Recent evidence shows that only 5% of infants taken to the doctor because of excessive crying are unwell. However, the crying can distress parents and lead to maternal depression, poor parent-child relationships, problems with child development, and infant abuse in extreme cases. 
In an initial study funded by the NIHR HTA Programme, worked with parents and NHS health visitors to develop a suitable support package, called the Surviving Crying package, it includes a website, a booklet based on the website, and a programme of sessions with a qualified practitioner to support parental coping.  Evaluation of the package showed that 58% of parents with excessively crying babies were clinically depressed prior to receiving the surviving crying, falling to 29% after receiving the package.

A Randomised Controlled Trial is being carried out to make sure these improvements in parent with excessively crying babies are due to the Surviving Crying package. The trial will show whether parents who have access to this package become less depressed and cope better with their baby’s crying, compared to parents who receive routine NHS support.
By developing NHS services which support parents whose babies cry excessively, it hopes to improve the parents’ wellbeing, coping and infant outcomes

Number of Participants

Total target sample size of 86 clusters (43 per arm) and 392 participants (196 per arm)

Trial Design

Multi-centre (8 primary care trusts) cluster (Health Visitor teams) randomised controlled trial
with an internal pilot.
In this Cluster Randomised Controlled trial, UK parents of all backgrounds with a healthy infant less than 20 weeks old who report concern about their infant’s excessive crying to their Health Visitor, will be invited to take part. 
Parents with excessively crying babies who consent to take part, and will be randomised into 2 groups.
Control group who will receive usual care and support from their Health Visitor. 
Treatment group who receive usual care and support plus the Surviving Crying package which will delivered by trained Health Visitors.
Measurement of parental depression at baseline will be assessed, with follow up assessments at 8 and 16 weeks post baseline assessment.

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