Pilot of remote support for caregivers of infants with colic/reflux
Research type
Research Study
Full title
Pilot of remote group interventions for caregivers of unsettled babies with colic and/or Gastroesophageal Reflux Disorder (GORD)
IRAS ID
296579
Contact name
Victoria Fallon
Contact email
Sponsor organisation
University of Liverpool
ISRCTN Number
ISRCTN15349263
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Summary of Research
Infant colic and reflux are common in babies and makes them irritable, unsettled, and cry excessively. Many caregivers find it difficult to cope with their infant’s distress, which negatively affects confidence and mental health. These caregivers are also often reluctant to attend baby groups, contributing to social isolation and lack of support. Infant colic and reflux generally resolve over time, but caregivers often seek medical advice and, without little supporting evidence, medications and special formula milks are often prescribed. This has led to increased costs and burden for health systems and parents. Literature recommends offering caregivers information, advice, and reassurance and this is usually done in medical consultations. Other forms of support for infant colic and reflux are, however, scarce.'Pilot and feasibility study of remote group interventions for caregivers of unsettled babies with colic and/or Gastroesophageal Reflux Disorder (GORD)’ will develop and evaluate the efficacy, acceptability and benefit of the following interventions in improving perceived symptoms of infantile colic and reflux, and improving measures of caregiver wellbeing: peer support group intervention, music intervention, and health education intervention, when compared with treatment as usual. Parenting confidence, perceived coping, perceptions of infant symptoms, depression and anxiety, will all be measured before and after taking part in the intervention, to assess the effectiveness of each intervention arm. Interim questions will also be administered to assess engagement and satisfaction with intervention content. All intervention conditions will run online to enable delivery during COVID-19. After the caregiver's 6 week involvement in their allocated intervention arm, they will take part in a focus group to evaluate feasibility, acceptability, and benefit of these interventions, when compared to treatment as usual, in caregivers of infants referred to Alder Hey for infant colic, reflux, and cow's milk protein allergy for study scale-up.
Summary of Results
Acceptability, but not feasibility, was established due to exceptionally poor participant uptake of the intervention (10% of those invited). The named research team are currently exploring avenues for follow-on funding to modify intervention arms with an aim to establish feasibility. Constructive feedback was obtained from staff and caregivers in post-intervention focus groups which will form conversation points in the proposed workshop series:
• Point of recruitment was believed to be too late.
Mothers indicated that accessing Alder Hey was a last resort in help-seeking for their baby’s condition, which may have contributed to poor levels of intervention uptake. Caregivers indicated that community-based recruitment may prove more fruitful for optimising participant benefit.
• Maintaining a group size of approximately 5 caregivers was recommended to prevent group splintering.
• Hybrid mode of intervention delivery was preferred.
i.e., having an initial face-to-face meeting so that the group may meet to establish initial rapport, with all remaining sessions taking place virtually.
• Participant-facing documentation was overly convoluted.
Caregivers indicated that they would have appreciated having a condensed leaflet summary of participant documentation which concisely communicates participant expectations during the study.The research team currently have two in-prep papers from the current study which will be published in relevant perinatal journals and at relevant national and international conferences.
REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0258
Date of REC Opinion
20 Oct 2021
REC opinion
Further Information Favourable Opinion