Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mental Health Wellness 1 Pregnancy Mother-Child Relations |
Other: Mellow Bumps Other: Chill-out in Pregnancy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care |
| Official Title: | Antenatal Parenting Support for Women Vulnerable in Pregnancy: an Exploratory Randomised Controlled Trial of Mellow Bumps |
- Changes in anxiety, depression & irritability on Adult Wellbeing Scale [ Time Frame: Baseline (pre-intervention), 8 weeks (post intervention) & at 8-12 weeks postnatal ] [ Designated as safety issue: No ]
- Differences in positive and negative parenting scores measured by Mellow Parenting Observation System (MPOS) [ Time Frame: 8 -12 week postnatal ] [ Designated as safety issue: No ]
- maternal salivary cortisol [ Time Frame: post-intervention ] [ Designated as safety issue: No ]Diurnal variations in salivary cortisol will be assessed post-intervention
- infant salivary cortisol stress response [ Time Frame: at 5 days post-natal ] [ Designated as safety issue: No ]salivary cortisol will be measured pre-and post-heelprick blood sampling.
| Enrollment: | 35 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Care as usual | |
| Active Comparator: Mellow Bumps + care as usual |
Other: Mellow Bumps
Mellow Bumps is a six week group-based antenatal programme designed to support families with additional health and social care needs. It is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation, to capture the period when the risk of miscarriage is low and fetal movement felt, but before major preoccupation with the delivery.
|
| Active Comparator: Chill-out in Pregnancy + care as usual |
Other: Chill-out in Pregnancy
Chill Out in Pregnancy (ChIP) is a relaxation programme that includes all the mother centred components of Mellow Bumps but none of the baby / mother-baby relationship components. It also runs for six weeks at two hours per week and is intended to decrease stress levels.
|
Detailed Description:
Lower than anticipated recruitment numbers have resulted in changes to the planned methodology of this trial. Firstly, participants were allocated to the three arms in groups/blocks of 6. Secondly, randomisation of the final group recruited was abandoned.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| NHS Greater Glasgow & Clyde | |
| Greenock, Inverclyde, United Kingdom | |
| NHS Ayshire & Arran | |
| Irvine, North Ayrshire, United Kingdom | |
| Principal Investigator: | Philip Wilson | University of Glasgow |
More Information
No publications provided
| Responsible Party: | Dr Philip Wilson, Senior Lecturer, University of Glasgow |
| ClinicalTrials.gov Identifier: | NCT01590212 History of Changes |
| Other Study ID Numbers: | 12/WS/0024 |
| Study First Received: | April 30, 2012 |
| Last Updated: | March 21, 2013 |
| Health Authority: | United Kingdom: National Health Service |
ClinicalTrials.gov processed this record on May 21, 2013