Clinical trial NCT01590212: Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women
Official title: Antenatal Parenting Support for Women Vulnerable in Pregnancy: an Exploratory Randomised Controlled Trial of Mellow Bumps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Pregnancy
Mother-Child Relations
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Scottish Collaboration for Public Health Research and Policy
First posted: 2012-05-02
Enrollment: 35
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
timeFrame: Post intervention (approximately 9-12 weeks after baseline)
measure: Depression Measured on EPDS
timeFrame: Post-intervention (approximately 9 -12 weeks after baseline)
measure: Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
timeFrame: Post-birth (8-12 weeks postnatal)
measure: Depression Measured on EPDS
timeFrame: Post-birth (8-12 weeks postnatal)
Secondary outcomes:
Other outcomes:
Locations:
city: Greenock
country: United Kingdom
facility: NHS Greater Glasgow & Clyde
state: Inverclyde
city: Irvine
country: United Kingdom
facility: NHS Ayshire & Arran
state: North Ayrshire
Study officials:
affiliation: University of Glasgow
name: Philip Wilson
role: PRINCIPAL_INVESTIGATOR
References: