Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women

NCT01590212 | Completed Results

• 1 other identifier: 12/WS/0024
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mental Health Wellness 1; Pregnancy; Mother-Child Relations

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (3)

Care as usual

NO INTERVENTION

Participants received care in line with local guidelines

Mellow Bumps + care as usual

ACTIVE COMPARATOR

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

Chill-out in Pregnancy + care as usual

ACTIVE COMPARATOR

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

Interventions

Mellow Bumps OTHER

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.

Mellow Bumps + care as usual

Chill-out in Pregnancy OTHER

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.

Chill-out in Pregnancy + care as usual

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• not identified as vulnerable through SNiP criteria
• less than 20 weeks or more than 30 weeks gestation at start of intervention

Sponsors & Collaborators

• University of Glasgow: lead
• Scottish Collaboration for Public Health Research and Policy: collaborator

Study Sites (2)

NHS Greater Glasgow & Clyde

Greenock, Inverclyde, United Kingdom

Location

NHS Ayshire & Arran

Irvine, North Ayrshire, United Kingdom

Location

MeSH Terms

Interventions

Pregnancy

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Limitations and Caveats

Participants lived in one health board area and one community health care partnership (CHCP) in the west of Scotland. Midwives may have approached only those potential participants who were thought to be likely to take part in the group programmes.

Results Point of Contact

• Title: Prof. Phil Wilson
• Organization: University of Glasgow

p.wilson@abdn.ac.uk

+44 (0)1463 255892

Study Officials

• Philip Wilson

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Primary Care and Rural Health

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 2, 2014
• Results First Posted: March 5, 2014

Record last verified: 2014-03

Locations

GB (2)