Antenatal Parenting Support for Women Vulnerable in Pregnancy: an Exploratory Randomised Controlled Trial of Mellow Bumps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Depression Measured on EPDS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •not identified as vulnerable through SNiP criteria
- •less than 20 weeks or more than 30 weeks gestation at start of intervention
研究组 & 干预措施
Care as usual
Participants received care in line with local guidelines
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.
干预措施: Mellow Bumps (Other)
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.
干预措施: Chill-out in Pregnancy (Other)
结局指标
主要结局
Depression Measured on EPDS
时间窗: 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
时间窗: 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),
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
时间窗: Post intervention (approximately 9-12 weeks after baseline)
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
时间窗: Post-intervention (approximately 9 -12 weeks after baseline)
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.
次要结局
未报告次要终点
研究者
Dr Philip Wilson
Professor of Primary Care and Rural Health
University of Aberdeen