Pregnancy Clinical Trial
Official title:
Antenatal Parenting Support for Women Vulnerable in Pregnancy: an Exploratory Randomised Controlled Trial of Mellow Bumps
Verified date | March 2014 |
Source | University of Glasgow |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Greater Glasgow & Clyde | Greenock | Inverclyde |
United Kingdom | NHS Ayshire & Arran | Irvine | North Ayrshire |
Lead Sponsor | Collaborator |
---|---|
University of Glasgow | Scottish Collaboration for Public Health Research and Policy |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Anxiety, depression and irritability measured on Adult Wellbeing Scale at 9-12 weeks after baseline. The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12), |
Post intervention (approximately 9-12 weeks after baseline) | No |
Primary | Depression Measured on EPDS | Depression as measured on the EPDS at 9-12 weeks after baseline Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30. |
Post-intervention (approximately 9 -12 weeks after baseline) | No |
Primary | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Anxiety, depression and irritability measured on the Adult Wellbeing Scale post-birth (approximately 8-12 weeks postnatal) The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12), |
Post-birth (8-12 weeks postnatal) | No |
Primary | Depression Measured on EPDS | Depression scores as measured on the EPDS post-birth (approximately 8-12 weeks postnatal) Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30. |
Post-birth (8-12 weeks postnatal) | No |
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