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| Name | Class |
|---|---|
| Scottish Collaboration for Public Health Research and Policy | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Wilson | University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Greater Glasgow & Clyde | Greenock | Inverclyde | United Kingdom | |||
| NHS Ayshire & Arran |
Two participants withdrew after randomisation but before baseline data was collected. The researcher was unable to contact two further participants to collect baseline data.
Participants were identified by community midwifes as having additional health and social care needs in pregnancy in two locations. Recruitment took place between May November 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mellow Bumps + Care as Usual | Mellow Bumps is a targeted intervention aimed at pregnant women with additional health and social care needs. Underpinned by attachment theory, there is a focus on: Improving maternal wellbeing by reducing stress and anxiety Increasing expectant mother's understandings of neonates' capacity for social interaction Emphasising the importance of early interaction to enhance brain development and attachment. Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant. |
| FG001 | Chill-out in Pregnancy + Care as Usual | Chill-out in Pregnancy is a targeted intervention aimed at pregnant women with additional health and social care needs. It is a stress-reduction programme which includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship elements. Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant. |
| FG002 | Care as Usual | Care-as-usual comprises routine antenatal care provided by the NHS in line with local guidelines. Services provided as part of an individividual woman's care plan. If indicated, a pre-birth case conference is held at 28-32 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Two participants withdrew and two were unable to be contacted.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mellow Bumps (MB) + 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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), | Posted | Mean | Full Range | Scores on a scale | Post intervention (approximately 9-12 weeks after baseline) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Phil Wilson | University of Glasgow | +44 (0)1463 255892 | p.wilson@abdn.ac.uk |
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| ID | Term |
|---|---|
| D011247 | Pregnancy |
| ID | Term |
|---|---|
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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| 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. |
|
| Post-birth (8-12 weeks postnatal) |
| Irvine |
| North Ayrshire |
| United Kingdom |
| BG001 | Chill-out in Pregnancy (CHiP) + 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. |
| BG002 | Care as Usual (CAU) | Participants received care in line with local guidelines. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Adult Wellbeing Scale | 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), | Mean | Full Range | Scores on a scale |
|
| Edinburgh Postnatal Depression Scale (EPDS) | 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. | Mean | Full Range | Scores on a scale |
|
| OG001 | 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. |
| OG002 | Care as Usual | All participants received care in line with local guidelines. |
|
|
| Primary | 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. | Posted | Mean | Full Range | scores on a scale | Post-intervention (approximately 9 -12 weeks after baseline) |
|
|
|
| Primary | 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), | Posted | Mean | Full Range | scores on a scale | Post-birth (8-12 weeks postnatal) |
|
|
|
| Primary | 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. | Posted | Mean | Full Range | scores on a scale | Post-birth (8-12 weeks postnatal) |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 9 | 0 | 9 |
| EG002 | Care as Usual | Participants received care in line with local guidelines | 0 | 14 | 0 | 14 |
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| Anxiety |
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| Outward directed irritability |
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| Inward directed irritability |
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