Infant prolonged crying and colic
Conditions
Interventions
The study will develop and evaluate a novel evidence-based intervention package. The package components will depend on the first stage of the research, but likely elements are written information leaf
Sponsors
De Montfort University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Infants over 6 months of age 2. Parents of infants whose crying does not distress their parents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. Evidence that parents take up and maintain involvement in the package, as well as rating it helpful and suitable for NHS use. 3. Evidence that Health Visitors engage and maintain involvement with the package and rate it worthwhile and suitable for routine NHS use. Measured by scores on validated questionnaires completed by parents | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
United Kingdom
Outcome results
None listed