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Clinical Trials/ISRCTN15349263
ISRCTN15349263
Completed
未知

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

niversity of Liverpool0 sites7 target enrollmentNovember 12, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Improving parenting confidence and mother-infant bonding, reducing anxiety and depression symptomatology through non-clinical, remote group interventions.
Sponsor
niversity of Liverpool
Enrollment
7
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 12, 2021
End Date
October 17, 2022
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Liverpool

Eligibility 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

  • Does not meet inclusion criteria

Outcomes

Primary Outcomes

Not specified

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