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

Not Applicable

Completed

• Conditions: Improving parenting confidence and mother-infant bonding, reducing anxiety and depression symptomatology through non-clinical, remote group interventions.; Not Applicable

• Registration Number: ISRCTN15349263
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-12
• Study Completion: 2022-10-17
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Current participant inclusion criteria as of 26/06/2023:
1. Caregivers of babies referred to Alder Hey infant feeding team for infant feeding difficulties due to unsettledness relating to infant colic, reflux, and/or cow’s milk protein allergy.
2. Infant age must be 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)
3. Caregivers must not have a current or historic clinical diagnosis of a serious mental health condition i.e., bipolar disorder, schizophrenia, and/or psychosis.

Previous participant 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.

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.