Title: Development and preliminary evaluation of an intervention package to support parents of excessively crying infants
Funder: Department of Health (England)

Abstract: DESIGN: A preliminary study to develop a novel intervention and assess the feasibility of delivering and evaluating it in the NHS. SETTING: Community Primary Care.TARGET POPULATION INCLUSION CRITERIA: Parents of any ethnic origin in the Leicestershire Partnership NHS Trust area who speak English or are supported by English speakers and have a healthy baby less than 6 months old whose excessive crying causes distress to either parent. EXCLUSION CRITERIA: infants over 6 months of age or judged ill by Health Visitors (HVs) or other medical staff. HEALTH TECHNOLOGY ASSESSED: A support package for parents of infants who cry excessively. The study will have 2 stages: Stage 1: Development of a Support Package. We will update a 2011 systematic review [2] and obtain example materials from research. For instance information leaflets and services for supporting parents with crying babies were proposed by an international expert panel[3]. We have collaborative links with promising studies [4-5] to provide example website/DVD materials. A nurse-provided group brief intervention focused on managing unsettled infant behaviour reduced maternal distress anxiety and depression [7]. Strengths included a clear theoretical foundation and evidence of implementation. Use of groups may limit costs. Studies in related areas too show nurse-provided interventions can help vulnerable parents and improve infant health-care [6-8]. This step will assemble example package components. Likely parts are special training for HVs information leaflets website/DVD materials group brief sessions for parents. Recent reviews highlight parental acceptance and take up of intervention components as crucial for intervention effectiveness [9-10]. To address this we will run three focus groups involving 20 parents who have sought NHS help for distress because of excessive infant crying. They will be recruited via the study’s HV and National Childbirth Trust (NCT) collaborators and asked what they found challenging what helped and which components are needed in the NHS. We will collect and analyse the resulting qualitative and rating data. With our NHS NCT Cry-sis and parent collaborators we will collate the resulting components into a package suitable for NHS use. The presentation and educational level of materials will be improved by Institute of Education staff. We will re-interview the 20 parents and run a workshop with HVs to confirm package suitability. Stage 2: Feasibility Study of Package Implementation in the NHS.We will recruit two groups. First HVs will invite parents who approach participating HV clinics during a 6 month period because of distress about infant excessive crying to participate. Where written informed consent is given they will be interviewed by researchers offered the package components and followed up. Estimates are that 20% of parents judge their baby cries excessively [2;11]. The two Leicester areas hosting the study have over 1000 births annually allowing the target 30 cases in a 6 month period. However this recruitment method faces two threats. One is unknown recruitment bias in the original surveys. It is possible that far fewer cases will seek HV help during a finite period such as 6 months threatening the study. Second this recruitment method will miss cases where parents do not approach HVs for instance due to lack of knowledge or confidence in themselves or the NHS. Such cases may be especially needy. To overcome these threats HVs will invite 225 families to enter the study at routine home visits in postnatal days 1-10. We expect 150 to give informed consent and to be followed up and screened for distress due to excessive infant crying by researchers. This should identify around 30 cases offered the package. This longitudinal approach will indicate differences between these parents and those recruited via HVs and may allow earlier detection and intervention before problems are entrenched. These two recruitment methods should ensure enough participants and indicate potential numbers and recruitment methods for a future RCT. The total 60 cases will be adequate for study purposes. MEASUREMENT OF OUTCOMES AND COSTSParents are likely to be offered the package at around 5 weeks of infant age (the crying peak). We will ask them for demographic data to rate their baby’s crying problem severity and to complete validated rating scales: Parenting Stress Inventory; Edinburgh Postnatal Depression Scale; Short Depression Anxiety & Stress Scale; EQ-5D Quality of Life Questionnaire. We will re-assess parents 4 weeks after package delivery using the same scales allowing indicative scores and score changes to be considered. Parents will be interviewed: (1) for use and satisfaction with each package component; (2) suitability of the questionnaires/ suggestions for other measures; (3) number and duration of NHS contacts due to infant crying; (4) duration of sole/ partial breast-feeding. We will assess how many parents and HVs complete the study. HVs will be asked to rate the package components and barriers/ facilitators to their use. To allow future cost-effectiveness analyses we will develop measures of costs of each component together with costs of crying-related NHS contact time for new and existing services. A large-scale RCT will be justified if parents and HVs are satisfied with the package take-up and outcome attrition is low and the package appears likely to reduce parental distress and be cost-effective in NHS use.SAMPLE SIZE & PROJECT TIMETABLE (see Flow Diagram): Development of package components will take 1 year. For the feasibility study HVs will recruit excessive crying cases for 6 months; follow-up completed in 7 months of year 2. For the longitudinal group participating HVs will each enrol 1-2 families/week giving 150 longitudinal cases in 4 months; follow-up within 6 months of year 2. Study total length 24 months.TEAM EXPERTISE: the PI has over 20 years experience conducting successful funded studies of infant crying and its impact on parents and publishing the results in leading journals. Other academics in the team have extensive experience in NHS health-economic research and Health Visitor research and training. NHS collaborators are HVs and Service Managers in Leicestershire Partnership NHS Trust. Other team members are NCT volunteers the Chairperson of the charity Cry-sis parents of previously crying babies a research statistician Leicester Clinical Trials Unit.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH