N/A
N=35
Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women
Mental Health Wellness 1 · Pregnancy · Mother-Child Relations
Bottom Line
View on ClinicalTrials.gov: NCT01590212 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale — 6.57; 4.67; 5.50; 5.29 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mellow Bumps (Other); Chill-out in Pregnancy (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of Glasgow
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale |
3.44; 3.44; 5.14; 3.56; 2.80; 4.00 | — |
| PRIMARY Depression Measured on EPDS |
5.22; 2.80; 5.56 | — |
| PRIMARY Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale |
3.44; 3.44; 5.14; 3.56; 2.80; 4.00 | — |
| PRIMARY Depression Measured on EPDS |
5.22; 2.80; 5.56 | — |
Summary
The purpose of this study is to compare the effectiveness of a relationships based antenatal intervention (Mellow Bumps) against a comparison intervention (Chillout In Pregnancy) and also against the normal antenatal care which is received during pregnancy (Care As Usual). The Mellow Bumps intervention will seek to improve maternal anxiety and maternal sensitivity whilst the Chillout In Pregnancy intervention will aim to improve only maternal anxiety. This will allow the researchers to determine what type of intervention, if any, is most successful at improving the outcomes of the mother and child. This will be measured by looking at the mother's stress response, anxiety, depression and irritability, the baby's stress response and the interactions between the mother and the baby. Participants in the study will be pregnant women who would be between 20 and 30 weeks pregnant at the start of the antenatal intervention. Participants will be chosen to take part in one of the three conditions (Mellow Bumps, Chillout In Pregnancy or Care As Usual) at random. All participants will be asked to complete questionnaires and give saliva samples prior to the intervention. The questionnaires will also be repeated at the end of the intervention and at a follow up occurring eight to twelve weeks after birth. Consent will also be sought to take saliva samples from the baby before and after a routine blood test when the baby is five days old. This information will then be evaluated to establish the effectiveness of the proposed interventions.
Eligibility Criteria
Inclusion Criteria
- pregnant, between 20 & 30 weeks gestation at start of intervention
- Identified by midwives as meeting Special Needs in Pregnancy (SNiP) criteria
- basic understanding of written and spoken English
Exclusion Criteria
- not identified as vulnerable through SNiP criteria
- less than 20 weeks or more than 30 weeks gestation at start of intervention
Data sourced from ClinicalTrials.gov (NCT01590212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.