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A support package for parents of excessively crying infants: development and feasibility study

Health Technology Assessment, No. 23.56

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Author Information
Southampton (UK): NIHR Journals Library; .


This study developed a support package that was well received by parents and professionals in the NHS, and it made recommendations for further evaluation in a RCT.



Around 20% of 1- to 4-month-old infants cry for long periods without an apparent reason. Traditionally, this was attributed to gastrointestinal disorder (‘colic’), but evidence shows that just 5% of infants cry a lot because of organic disturbances; in most cases, the crying is attributable to normal developmental processes. This has led to a focus on the impact of the crying on parents. Parental vulnerabilities influence how parents evaluate and respond to the crying and predict adverse outcomes. By developing evidence-based services that support parents, this study was designed to take the first steps towards national health services that enhance the coping and well-being of parents whose babies excessively cry. Related aims were to improve these infants’ outcomes and how NHS money is spent.


To develop a novel intervention package to support parents of excessively crying infants and to examine the feasibility of delivering and evaluating it in the NHS.


Stage 1 of this study aimed to (1) complete a literature review to identify example support materials, (2) obtain parents’ guidance on the support needed when a baby cries excessively, together with their evaluation of the example materials, and (3) develop a support package based on the results. Stage 2 aimed to (1) recruit 60 parents whose babies were currently excessively crying, (2) assess parents’ and NHS professionals’ willingness to complete a study of the support package, (3) measure the use and evaluation of the package components, (4) estimate the package component costs and (5) provide evidence on the feasibility and methods for a large-scale trial.


Primary health care.


Stage 1: 20 parents of previously excessively crying infants and 55 health visitors (HVs) or specialist community public health nurses (SCPHNs). Stage 2: 57 parents of currently excessively crying infants and 124 HVs/SCPHNs.


The support package included a website, a printed booklet and a programme of cognitive–behavioural therapy-based sessions delivered to parents by a qualified practitioner.

Main outcome measures:

(1) Demographic data, (2) figures for parents’ use of the package components and continuation in the study, (3) parents’ and HVs’/SCPHNs’ ratings of the package components and suitability for NHS use, (4) questionnaire measures of parental well-being and infant health and (5) costs.


Most parents (95%) accessed the website or printed materials and half (51%) attended the practitioner sessions. All 52 parents and 85% of HVs/SCPHNs providing data would support the inclusion of the package in the NHS. It was associated with reduced parental frustration, anxiety, depression, reported infant crying and contacts with health professionals and increased knowledge about crying. Methods for a full trial and figures for the cost of excessive infant crying for the NHS and each package element were identified.


No control group was included. Most of the recruited parents were white, well educated and in stable relationships.


Parents and HVs/SCPHNs recognise the need for NHS provisions that support parents of excessively crying babies and consider the materials developed to meet that need. A full-scale randomised controlled trial is feasible and desirable.

Trial registration:

Current Controlled Trials ISRCTN84975637.


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 56. See the NIHR Journals Library website for further project information.


About the Series

Health Technology Assessment
ISSN (Print): 1366-5278
ISSN (Electronic): 2046-4924

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 12/150/04. The contractual start date was in November 2014. The draft report began editorial review in May 2017 and was accepted for publication in August 2018. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Stephen Morris is a member of the National Institute for Health Research Health Services and Delivery Research Board and the Public Health Research Research Funding Board.


This report contains transcripts of interviews conducted in the course of the research and contains language that may offend some readers.

Last reviewed: May 2017; Accepted: August 2018.

Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by St James-Roberts et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK547499DOI: 10.3310/hta23560


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