Title: Cluster Randomised Controlled Trial of a Service to Support the Mental Health and Coping of Parents with Excessively Crying Infants
Funder: Department of Health and Social Care

Abstract: BACKGROUND: 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. By developing NHS services which support parents whose babies cry excessively, we hope to improve the parents’ wellbeing and coping, infant outcomes, and how NHS money is spent._x000D_ _x000D_ PROGRESS SO FAR: In an initial study funded by the NIHR HTA Programme, we reviewed the evidence and worked with parents and NHS health visitors to develop a suitable support package. Called the Surviving Crying package, it included a website, a booklet based on the website, and a programme of sessions with a qualified practitioner to support parental coping. To evaluate this package, 52 parents with excessively crying babies were referred to the study by health visitors. Before receiving the Surviving Crying package, 30 of the 52 parents were clinically depressed, halving to 15 after receiving the package. Reductions occurred in the number of parents reporting the crying to be a large or severe problem (from 28 to 3 parents) or feeling very or extremely frustrated by the crying (from 31 to 1 parent). The parents' confidence, knowledge of infant crying, and sleep, also improved. All 52 parents and 85% of 50 health visitors wanted the package to be included in the NHS._x000D_ _x000D_ We now need to carry out a Randomised Controlled Trial to make sure these improvements are due to the Surviving Crying package. From our patient and public involvement work, most parents said they would be willing to take part in such a trial. 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. We will also find out whether the Surviving Crying package gives value for money for the NHS. In this trial, parents with excessively crying babies will be divided into 2 groups. One (control) group will be chosen at random to receive usual care and support from their health visitor. The other (treatment) group will be chosen at random to receive usual care and support plus the Surviving Crying package._x000D_ _x000D_ We expect the treatment group parents to cope better and become less depressed than the control group parents. Follow up measures will show whether these improvements are maintained after the age when most infants stop crying excessively. Where parents remain concerned about their baby’s crying at the follow-up point, they will be offered specialist support. We will also assess parents' and health visitors' views of usual care and the Surviving Crying package and examine how to improve the delivery of services to minority and disadvantaged communities. Lastly, we will compare the Surviving Crying package and usual services on costs._x000D_ _x000D_ This research has been developed with the help of parents of excessively crying babies, health visitors, doctors, and voluntary organisations. If the trial proves the Surviving Crying materials to be worthwhile, they can be used in the NHS to improve health visiting services and to help parents with excessively crying babies.

Lay abstract: Research Question: Are usual health visiting services supplemented by the Surviving Crying (SC) package more clinically effective, and cost-effective, than usual services in improving the mental health and coping of parents with an excessively crying infant less than 20 weeks old?_x000D_ _x000D_ Background: Around 20% of infants cry for prolonged periods during the first four postnatal months. Where parents cannot cope, this can lead to parental depression, poor parent-child relationships, problems with child development, and infant abuse in rare cases. With NIHR HTA support, we have completed a feasibility study to develop the ‘Surviving Crying’ (SC) package to support parents in this position. 52 parents of excessively crying infants and 50 NHS health visitors (HVs) provided evaluation data. 30 parents met clinical criteria for depression at baseline, halving to 15 after receiving the SC package. Parents’ NHS contacts reduced. All 52 parents and 85% of the HVs wanted the package to be included in the NHS. Most (86%) parents were willing to participate in a controlled trial of the package. _x000D_ _x000D_ Proposed Trial Aims & Measures: Population: 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 HV. Intervention: The SC support package delivered to parents by HVs. Comparator: Usual NHS HV services. Primary outcome: Edinburgh Postnatal Depression Scale (EPDS) measure of parental depression 8 weeks after baseline. Secondary outcomes: EPDS scores at 16 weeks follow-up; proportion of parents with EPDS score of 10 or more, validated measures of parental anxiety, sleep, social supports, knowledge of infant crying, amount of infant crying, parents’ ratings of how frustrating and problematic the crying is for them, at both 8 & 16-week follow-ups. Other measures: Parental and infant health, breast-feeding persistence; NHS contacts; parents’ use and parent and HV ratings of services; health economic measures. Setting and Timing: Primary care NHS postnatal services._x000D_ _x000D_ Design & Timelines: Multi-centre (8 primary care trusts) cluster (HV teams) randomised controlled trial with an internal pilot. The sample size is designed to detect a 2-point difference in mean EPDS score (10.5 for the control group and 8.5 for the intervention group). With a 5% level of significance (two-sided) 90% power, allowing for attrition and cluster trial methods, this gives a total target sample size of 86 clusters (43 per arm) and 392 participants (196 per arm). Pilot Phase: HVs trained and certified in delivering the SC package and procedures implemented to avoid participant bias in intervention and control groups. Main Trial: If progression criteria are met, the study will be extended to the planned number of clusters, HVs and participants. _x000D_ _x000D_ Dissemination: We will work with NHS and Social Care administrative and commissioning groups and networks (CRN, PHE, iHV) throughout the trial. We will disseminate via conferences, peer-reviewed publications, clinical networks, media and social media. _x000D_ _x000D_ Outcomes: (1) Evidence-based NHS services for parents distressed by their infant’s excessive crying; (2) improved parental coping, reduced parental depression, improved infant outcomes, enhanced health visiting as an evidence-based profession; improvement in how NHS money is spent; (3) The SC website, booklet, and online CBT-based training course for primary healthcare professionals, made freely available.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH;REPRODUCTIVE HEALTH AND CHILDBIRTH