Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women

University of Glasgow

Status: Completed

Conditions: Mother-Child Relations; Mental Health Wellness 1; Pregnancy

Treatments: Other: Mellow Bumps; Other: Chill-out in Pregnancy

Study type: Interventional

Funder types: Other

Identifiers

NCT01590212

12/WS/0024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 3 patient groups

Care as usual

No Intervention group

Description:

Participants received care in line with local guidelines

Mellow Bumps + care as usual

Active Comparator group

Description:

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.

Treatment:

Other: Mellow Bumps

Chill-out in Pregnancy + care as usual

Active Comparator group

Description:

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.

Treatment:

Other: Chill-out in Pregnancy