Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women

Not Applicable

Completed

Conditions: Pregnancy
Mental Health Wellness 1
Mother-Child Relations

Registration Number: NCT01590212

Lead Sponsor: University of Glasgow

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression Measured on EPDS	Post-birth (8-12 weeks postnatal)	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.
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale	Post-birth (8-12 weeks postnatal)	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),

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): NHS Greater Glasgow & Clyde
🇬🇧
Greenock, Inverclyde, United Kingdom
NHS Ayshire & Arran
🇬🇧
Irvine, North Ayrshire, United Kingdom
NHS Greater Glasgow & Clyde
🇬🇧Greenock, Inverclyde, United Kingdom