A study to explore the suitability of group online peer support, music, and health education interventions to caregivers of unsettled babies with colic, reflux, and/or cow's milk protein allergy

INTERVENTION: The current study is a pilot and feasibility study to assess the feasibility and acceptability of three non‐medical remote group interventions to support caregivers of unsettled babies with colic and/or GastrOesophageal Reflux Disease (GORD, hereafter referred to as ‘reflux’), who had been referred to Alder Hey Children’s NHS Foundation Trust (hereafter referred to as ‘Alder Hey’). Intervention arms include music intervention, health education, and peer support. The acceptability and benefits of these arms will be compared to treatment as usual. 40 participants with infants under six months of age at referral will be allocated to four conditions (10 participants in each intervention arm): music intervention, health education, peer support, and treatment as usual. All caregivers and infants will continue to receive treatment as usual. Evidence shows that infantile colic, reflux, and cow’s milk protein allergy symptoms decline over time (Czinn & Blanchard, 2013; Wolke, Bilgen, & Samara, 2017). To maximise the potential benefit of the current study to caregivers and infants in terms of alleviating infantile symptoms and in improving caregiver coping and wellbeing with infantile symptoms, it is imperative to capture when infantile colic and reflux symptoms are most acute and thus when need for support is likely to be most crucial for determining infant and caregiver wellbeing outcomes. Recruiting caregivers when infantile symptoms are most acute is imperative to accurately assess whether intervention attempts are effective in reducing perceived severity of infant colic and reflux symptoms, improving perceived parenting confidence, mental health (namely depression and anxiety), and caregiver–baby bonding, for feasibility and CONDITION: Improving parenting confidence and mood measures, and improving infantile colic and/or reflux symptoms through non‐clinical, remote group interventions. ; Not Applicable PRIMARY OUTCOME: Perceived parenting self‐efficacy, measured using pre and post intervention administration of the Perceived Maternal Parenting Self‐Efficacy (PMPSE) tool (Barnes & Adamson‐Macedo, 2007). This measure will be administered before, and after the participant's 6 week involvement in the current intervention study. INCLUSION CRITERIA: 1. Caregivers of babies referred to Alder Hey for infant colic, reflux, and/or cow’s milk protein allergy with infants younger than 6 months at time of referral, born at >34 gestational weeks, without known co‐morbidities or evidence of faltering growth as per NICE guidance (2017) 2. Caregivers must not have a current or historic clinical diagnosis of a serious mental health condition i.e., bipolar disorder, schizophrenia, and/or psychosis. SECONDARY OUTCOME: ; Measured before and after the participant's 6 week involvement in the current study:; 1. Perceptions of infant colic (ICS; Ellett et al, 2002) and/or reflux (I‐GER‐Q; Kleinman et al, 2006) symptoms; 2. Infant feeding method (Davie, 2018); 3. Depression symptoms (10‐item Edinburgh Postnatal Depression Scale, EPDS; Cox, Holden, & Sagovsky, 1987); 4. Anxiety symptoms (16‐item Postpartum Specific Anxiety Scale, PSAS; Fallon et al, 2021); 5. Patient satisfaction with healthcare professional support (7 item Short Assessment of Patient Satisfaction, SAPS; Hawthorne et al, 2014). All aforementioned measures will be administered; 6. Each intervention arm will also assess adherence and satisfaction with the intervention to which they had been allocated on an interim, weekly basis during the six‐week intervention period using bespoke questionnaires;