Development and preliminary evaluation of an intervention package to support parents of excessively crying infants

Not Applicable

Completed

• Conditions: Infant prolonged crying and colic; parental concern and distress because of their infant's crying.; Pregnancy and Childbirth

• Registration Number: ISRCTN84975637
• Lead Sponsor: De Montfort University (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31597591 (added 11/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-15
• Study Completion: 2016-08-31
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

1. Parents of any ethnic origin in the Leicestershire Partnership NHS Trust area
2. Speak English, or are supported by English speakers
3. Have a healthy baby less than 6 months old whose excessive crying causes distress to either parent

Exclusion Criteria

1. Infants over 6 months of age
2. Parents of infants whose crying does not distress their parents

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Successful development of an evidence-based package of support materials for parents distressed by their baby?s excessive crying, together with methods for assessing its effectiveness and costs in NHS use.<br> 2. Evidence that parents take up and maintain involvement in the package, as well as rating it helpful and suitable for NHS use.<br> 3. Evidence that Health Visitors engage and maintain involvement with the package and rate it worthwhile and suitable for routine NHS use.<br><br> Measured by scores on validated questionnaires completed by parents<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Provisional evidence of improvements from baseline (pre-package) to outcome (1 month later) in parental mental health, wellbeing and quality of life from validated questionnaire measures.<br> 2. A proposal about the feasibility and need for a large scale controlled study of the package, together with recommendations about the design and methods such a study might employ.<br>