Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women

This study has been completed.
Sponsor:
Collaborator:
Scottish Collaboration for Public Health Research and Policy
Information provided by (Responsible Party):
Dr Philip Wilson, University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01590212
First received: April 30, 2012
Last updated: March 5, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale [ Time Frame: Post intervention (approximately 9-12 weeks after baseline) ] [ Designated as safety issue: No ]

    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),


  • Depression Measured on EPDS [ Time Frame: Post-intervention (approximately 9 -12 weeks after baseline) ] [ Designated as safety issue: No ]

    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.


  • Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale [ Time Frame: Post-birth (8-12 weeks postnatal) ] [ Designated as safety issue: No ]

    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),


  • Depression Measured on EPDS [ Time Frame: Post-birth (8-12 weeks postnatal) ] [ Designated as safety issue: No ]

    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.



Enrollment: 35
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Care as usual
Participants received care in line with local guidelines
Active Comparator: Mellow Bumps + care as usual
MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB 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.
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
CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590212

Locations
United Kingdom
NHS Greater Glasgow & Clyde
Greenock, Inverclyde, United Kingdom
NHS Ayshire & Arran
Irvine, North Ayrshire, United Kingdom
Sponsors and Collaborators
University of Glasgow
Scottish Collaboration for Public Health Research and Policy
Investigators
Principal Investigator: Philip Wilson University of Glasgow
  More Information

No publications provided

Responsible Party: Dr Philip Wilson, Professor of Primary Care and Rural Health, University of Aberdeen
ClinicalTrials.gov Identifier: NCT01590212     History of Changes
Other Study ID Numbers: 12/WS/0024
Study First Received: April 30, 2012
Results First Received: July 31, 2013
Last Updated: March 5, 2014
Health Authority: United Kingdom: National Health Service

ClinicalTrials.gov processed this record on July 22, 2014