Mental health to help parents/carers cope with an infant's excessive crying Mental and Behavioural Disorders
Conditions
Interventions
The overall aim of the trial is to test the clinical effectiveness and cost-effectiveness of statutory health visiting (HV) services supplemented by SC-based service compared to statutory health visit
Sponsors
De Montfort University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Parents/carers aged 18 years or older with a healthy infant up to 20 weeks old (at time of consent), who express concern about their infant’s excessive crying to their Health Visitor 2. Written/electronic informed consent
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 18/02/2026: 1. Any seriously ill infant (at time of consent), requiring inpatient hospitalisation 2. Involved with any other clinical trial at the time of consent or 3 months prior _____ Previous key exclusion criteria: 1. Any infant where excessive crying is judged by a doctor to be due to illness requiring medical management 2. Involved with any other clinical trial at the time of consent or 3 months prior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parental depression measured using the Edinburgh Postnatal Depression Scale (EPDS) score at 8 weeks post-baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parental depression measured using the Edinburgh Postnatal Depression Scale (EPDS) score 16 weeks post-baseline; proportion of parents/carers with EPDS score of 10 or more 2. Anxiety measured using the Generalised Anxiety Disorder Assessment (GAD-7) Scale at 8 and 16 weeks post-baseline 3. Self-rated health utility and quality of life measured using EuroQol-5D-5L at 8 and 16 weeks post-baseline 4. Confidence of a parent/carer in their parenting role measured using the Maternal Confidence Scale (MCQ) at 8 and 16 weeks post-baseline 5. Knowledge of infant crying, amount of perceived infant crying, and parents/carers’ ratings of how frustrating and problematic the crying is for them, measured using the crying knowledge scale at 8-week post-baseline follow-ups 6. Relationship satisfaction measured using the Partner Relationship Quality (CSI-4) at 8 and 16 weeks post-baseline 7. Parental and infant health, breastfeeding persistence measured using researcher asked questions at 8 weeks and 16 weeks post-baseline 8. Health economic measures assessed using researcher asked questions at 8 weeks and 16 weeks post-baseline 9. Contacts with the NHS, parents’ use and parents’ and HVs’ ratings of services assessed using researcher asked questions at 8 weeks post-baseline | — |
Countries
England, United Kingdom
Outcome results
None listed