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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

Investigating the acceptability and feasibility of online group peer support, health education, and music interventions to caregivers of unsettled infants with colic, GOR(D), and/or CMPA: An empty trial study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15349263
Enrollment
40
Registered
2021-11-12
Start date
2021-10-30
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving parenting confidence and mother-infant bonding, reducing anxiety and depression symptomatology through non-clinical, remote group interventions. Other

Interventions

Current interventions as of 03/01/2024: The current study will aim to investigate the acceptability and feasibility of three non-clinical remote group interventions to support caregivers of unsettled
Wolke, Bilgen, & Samara, 2017). To maximise the potential benefit to caregivers, therefore, participants will be allocated to an intervention arm opportunistically so that the given arm can run withou

Sponsors

University of Liverpool
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Current secondary outcome measures as of 26/06/2023: Measured before and after the participant's 6-week involvement in the current study: 1. Infant feeding method (Davie, 2018) 2. Depression symptoms (10-item Edinburgh Postnatal Depression Scale, EPDS; Cox, Holden, & Sagovsky, 1987) 3. Anxiety symptoms (16-item Postpartum Specific Anxiety Scale, PSAS; Fallon et al, 2021) 4. Patient satisfaction with healthcare professional support (7-item Short Assessment of Patient Satisfaction, SAPS; Hawthorne et al, 2014). All aforementioned measures will be administered 5. 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 Previous secondary outcome measures: 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

Countries

England, United Kingdom

Contacts

Public ContactLeanne Jackson
leanne.jackson@liverpool.ac.uk+44 (0)151 795 7511

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026