Around one in five infants cries excessively during the first four months, and when parents cannot cope, the consequences can include depression, poor parent-child bonding, and—in rare cases—abuse. This trial tests whether adding a support package called “Surviving Crying” (SC) to usual health visiting services improves parents’ mental health and ability to cope. The problem is that standard NHS postnatal care often leaves parents of excessively crying infants without targeted help. A feasibility study found that among 52 parents who received the SC package, the number meeting clinical criteria for depression halved—from 30 to 15—and parents’ NHS contacts dropped. Most parents and health visitors wanted the package made available on the NHS. If the trial confirms these results, the SC package could become a routine NHS service. That would mean fewer parents developing depression, better infant outcomes, and more efficient use of NHS money. The package—a website, booklet, and online CBT-based training for health visitors—would be made freely available, potentially changing how primary care supports families during a stressful but common early-life challenge.
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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? 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. 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. 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. 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. 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.
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