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The Surviving Crying study: progress report for the first stage of research

03 March 2016

This report by Ian St James-Roberts describes the first stage of the Surviving Crying study.

Web conversation

Ian St James-Roberts PhD
Professor of Child Psychology, UCL Institute of Education, University College London

Correspondence: [email protected]


Key points

This report describes the first stage of the Surviving Crying study, which is designed to develop an information and support package for parents who are worried about their baby’s excessive crying:

  • The first stage of the study has employed focus group methods with parents of previously crying babies to identify the types of support materials and methods of delivering them that are suitable for parents in this position
  • The support package developed includes a website, printed materials and support sessions delivered directly to parents by a practitioner qualified in cognitive behavioural therapy (CBT) methods
  • The report also introduces stage two of the study, which is designed to provide a provisional evaluation of the package, its costs, and its suitability for use in the NHS. This is underway.

Key words: Infant crying, colic, excessive crying, prolonged crying, parental support


​​​​​​Abstract

The term ‘infant colic’ has been used to refer both to ‘prolonged’ infant crying (a measure of crying) and to parents’ concern that ‘excessive’ crying is a sign that something is wrong with their baby. There is growing evidence that the terms need to be distinguished, so that the traditional focus on the crying is balanced by an equal focus on the impact of the crying on parents. The Surviving Crying study is a first step towards developing and evaluating routine NHS services to support parents who are worried about their baby’s excessive crying. This report summarises the study’s overall aims and methods and describes the first stage, designed to develop this parental support package. The package comprises a website, printed materials for parents who do not use the internet and a CBT-based programme manual for delivering direct one-to-one or small-group support sessions to parents. Stage two of the study, designed to provide an initial evaluation of the package and its suitability for use in the NHS, is underway. An email address exists for practitioners and researchers who wish to be kept informed.


Introduction

The Surviving Crying study is a first step towards developing and evaluating routine NHS services to support parents who are worried about their baby’s excessive crying. The study is based at De Montfort University, Leicester and funded by the NIHR HTA Programme. It involves a collaboration with Leicestershire Partnership NHS Trust (LP Trust), University College London, Leicester and Middlesex Universities and the charities National Childbirth Trust (NCT) and Cry-Sis

Surveys in the UK and other countries have found that around 20 per cent of one- to four-month-old infants cry for long periods without apparent reason (Alvarez, 2004; St James-Roberts and Halil, 1991). Traditionally, this crying was attributed to gastro-intestinal disorder and pain and known as ‘infant colic’ (Illingworth, 1954; Wessel et al, 1954). More recently, evidence has accumulated that most such infants are healthy and grow and develop normally (Lehtonen, 2001; Stifter and Braungart, 1992). Many normal babies have a crying ‘peak’ at around one to two months of age (Barr, 1991; St James-Roberts and Halil, 1991). In most cases, this peak and the ‘unsoothable’ crying bouts that alarm parents resolve spontaneously by five months of age and appear to be linked to normal development (Barr, et al., 2005; Barr and Gunnar, 2000). A more detailed review of this evidence is available elsewhere (St James- Roberts et al, 2013).

Alongside these findings, the term ‘infant colic’ has been criticised for being confused and confusing (St James-Roberts, 2012). In particular, this term has been used to refer both to ‘prolonged’ infant crying (a measure of crying amount) and to parents’ concern that the ‘excessive’ crying is a sign that something is wrong with their baby. Although prolonged and excessive crying are related, there is growing awareness that they need to be distinguished, so that the traditional focus on the crying is balanced by an equal focus on the impact of the crying on parents. There is evidence, for instance, that crying judged to be ‘excessive’ can trigger premature termination of breastfeeding (Howard et al, 2006), overfeeding (Stifter et al, 2011), parental distress and depression (Kurth et al, 2011; Murray and Cooper, 2001), poor parent-child relationships (Papouŝek et al, 2001), problems with long-term child development (Wolke et al, 2002), and infant abuse in a small number of cases (Barr et al, 2006). Yet there are no tried and tested NHS practices for supporting parents in managing the crying. Instead, parents turn to popular books, magazines or websites, which give conflicting advice (Catherine et al, 2008). Alternatively, the distraught parents take their baby to their doctor or hospital A&E department, even though only around five per cent of such infants have an organic disturbance (Freedman et al, 2009).

By providing evidence-based services that support parents, the Surviving Crying study is designed to improve parental wellbeing, community health services, infant outcomes and the way in which NHS money is spent.


Study aims

This is a two-year study. Stage one (development of the intervention package) began in November 2014 and lasted a year. Aims at this stage were to identify existing support materials for parents of excessively crying babies and to develop a new, evidence-based support package for this purpose that is suitable for NHS use. The aims, methods and outcomes of this stage of the research are described in more detail below.

Stage two of the study (feasibility study of package implementation in the NHS) runs for 12 months from November 2015. This stage of the research will provide provisional data on the effectiveness and cost of the package, find out whether parents and health visitors consider it worthwhile and make recommendations about its inclusion and further evaluation in the NHS.


Methods used in Stage One

Ethical approval and registration De Montfort University ethical approval reference: 1345. IRAS project ID: 152836 approved 17/11/2014. NRES reference 14/EM/1202. Leicestershire Partnership NHS Trust (LP Trust) approval reference: PAED0706. International Randomised Controlled Trial database: Registration no. ISRCTN84975637.

The study is coordinated by a study management group, which has met three times. This group includes the research team, LP Trust health visitors, a paediatrician, a GP representative, a health economist, members of Leicester Clinical Trials Unit and NCT, Cry-Sis and parent representatives. The study is regulated by an NIHR-appointed steering committee, which met in June 2015 and approved the study’s progress so far.

Participants

Parents of any ethnic origin in the LP Trust area who spoke English, or were supported by English speakers, and had a healthy baby less than six months old whose excessive crying had previously caused distress to either parent were eligible to take part. Participation was intentionally based on parental reports of distress because of their baby’s excessive crying rather than measures of the crying. Local health visitor experience showed that most non-English-speaking parents were accompanied by English-speaking family members or friends. Although translation into other languages was desirable, the costs involved suggested this would be better left to a later stage. To prepare for later research, the researchers recorded how many non-English speakers were contacted during the study and any obstacles to service delivery that resulted from a language barrier. Infants over six months of age or judged ill by health visitors or other qualified NHS professionals were excluded.

Procedure

With support from LP Trust managers who are partners in the study, the first step was to establish collaborative arrangements with health visitors and other professionals working in the Trust. Briefing workshops were held with five health visitor teams working in the city or county. As a result, 55 health visitors gave written informed consent to take part by referring parents who had previously been distressed due to their baby’s excessive crying to the study team. Following this initial contact, the researchers explained the study in full and obtained parents’ written informed consent to take part.

Step two involved updating a systematic review of the evidence (Douglas and Hill, 2011) to obtain a shortlist of example support materials for scrutiny by these parents. Guidance for supporting parents with crying babies has been published by an international expert panel (Barr et al, 2001). Digital, audio-visual and printed support materials about infant crying and its management by parents have been developed and provisionally evaluated by Australian, Canadian/ USA and UK research groups (Barr et al, 2009; Cook et al, 2012; Coster et al, 2015; Fisher et al, 2010). After contacting the authors and authorities involved, the researchers obtained four sets of example materials and permission to use them in stage one of the study. These included website materials, information booklets and training for practitioners to allow them to deliver support sessions directly to parents. Evidence was also noted that in related areas practitioner-provided interventions, particularly based on cognitive behavioural therapy (CBT) rationales, can help vulnerable parents and reduce depression (Stevenson et al, 2010). CBT treatments for acute/moderate adult emotional distress are supported by NICE (2009) and the use of groups may improve service access and limit costs (Stevenson et al, 2010).

Recent reviews highlight parental acceptance and take-up of intervention components as crucial for intervention effectiveness (Moore et al, 2012; Olds et al, 2007). Accordingly, in step three the researchers ran focus groups with 20 of the parents who had previously sought NHS help for distress because of excessive infant crying. Both mothers and fathers were invited to take part and two fathers participated. They were asked what they had found challenging, what had helped, and about family, community and health service supports. In addition, they were asked to evaluate the shortlisted example materials and to advise on how to adapt them for NHS use. They also identified the methods they currently used to access health information and the methods of delivering information that parents in their position would find most suitable. The resulting data was collected for analysis using NVivo 10 for the qualitative data and statistical analysis of the rating data.

Based on the parental views and preferences, the final step involved working with a commercial website company, Consider Creative, to develop a website and other materials for delivering the support package.


Outcomes from Stage One 

The main outcome of the study so far is a package of materials to support parents who are worried about their baby’s excessive crying, comprising a ‘Surviving Crying’ website, printed materials for parents who do not use the internet, and a CBT-based programme manual for delivering direct one-to-one or small-group support sessions to parents. The website includes evidence about crying, guidance for parents, stories and videos from parents who have
survived their baby’s crying and access to other sources of support. It can be accessed by mobile phone or tablet, as well as on a computer. The package components have received feedback from NHS and parent collaborators and the presentation and reading level of the materials has been checked to ensure they are suitable for use in the general community.

Secondly, together with the LP Trust safeguarding officers and clinical staff, the study’s paediatrician has developed safeguarding protocols to ensure the safety of parents and babies involved in stage two of the study. Thirdly, methods for collecting the stage two data have been finalised in collaboration with Leicester Clinical Trials Unit, which will be responsible for data entry and analysis.

The researchers intend to recruit two groups of parents. To enrol a referred group, around 60 LP Trust health visitors will invite parents who approach them during a six-month period with concerns over excessive infant crying to participate. Where initial written informed consent is given, they will be interviewed by researchers, offered the package components, and followed up. Estimates are that around 20 per cent of parents judge their baby cries to be excessive (St James-Roberts and Halil, 1991; Douglas and Hill, 2011). The LP Trust areas targeted for the study see more than 1,000 births annually, thus allowing the target 30 cases for a six-month period.

To recruit a community group, health visitors will invite 15 families per week to enter the study at the statutory home visit in postnatal days 10 to 14. It is expected that 10 per week will give informed consent to be followed up and screened for distress due to excessive infant crying, giving a total of 150 families in 15 weeks. This will ensure a sufficient number of participants and should identify 30 cases offered the package. The longitudinal community approach will also indicate differences between these parents and those who approach health visitors for help. The two recruitment methods should indicate potential numbers and recruitment methods for a future large-scale study and allow adjustment of the recruitment strategy if the expected numbers are not forthcoming.

The primary outcome measures will be:

  1. Demographic data for the parents and infants
  2. Figures for parents’ take-up of the package components and persistence in the study
  3. Parents’ rating-scale measures of the effectiveness of the package components in providing support
  4. Health visitor rating-scale measures of the package components’ effectiveness and suitability for NHS use.


The secondary outcome measures will be:

  1. Parents’ scores on depression, anxiety, quality of life and coping measures and changes in those scores
  2. Parental reports of the duration of full and partial breastfeeding
  3. Whether parents have gained knowledge about infant crying as a result of participating in the study, using methods developed by Barr et al (2006)
  4. Figures for the cost of NHS services involved in supporting parents of excessively crying infants, and for each support package component provided by the study. The health economic data will be analysed to assess the amount of staff-parent contact time and associated potential costs to the NHS. Methods will be developed to allow cost-effectiveness analyses. A study co-applicant and expert in health economic analyses will supervise the data collection and analysis involved.
  5. Parents’ willingness to accept randomisation to treatment or control conditions in a future randomised controlled trial designed to evaluate the package more thoroughly.

Dissemination of the findings from the study will continue over the next 12 months and involve workshops for NHS professionals as well as further publications. Those wishing to be added to the mailing list and receive further information as it appears should email the researchers at: [email protected]


Acknowledgements

This study is supported by a grant from the National Institute for Health Research HTA Programme (HTA 12/150/04). I would like to acknowledge the major contribution to this research made by Surviving Crying study research team (Rosemary Garratt, Charlotte Powell, Deborah Bamber, Jaqui Long, Sue Dyson), LP Trust staff, the study management and steering groups, and the health visitors and parents who have taken part.


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