Trial Outcomes & Findings for Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women (NCT NCT01590212)
NCT ID: NCT01590212
Last Updated: 2014-04-02
Results Overview
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),
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Post intervention (approximately 9-12 weeks after baseline)
Results posted on
2014-04-02
Participant Flow
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.
Two participants withdrew after randomisation but before baseline data was collected. The researcher was unable to contact two further participants to collect baseline data.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
14
|
|
Overall Study
Baseline (Pre-intervention)
|
10
|
9
|
12
|
|
Overall Study
Post-intervention
|
7
|
6
|
10
|
|
Overall Study
COMPLETED
|
9
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
3
|
Baseline Characteristics
Mellow Bumps RCT - Antenatal Intervention for Vulnerable Women
Baseline characteristics by cohort
| Measure |
Mellow Bumps (MB) + Care as Usual
n=10 Participants
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 (CHiP) + Care as Usual
n=9 Participants
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.
|
Care as Usual (CAU)
n=12 Participants
Participants received care in line with local guidelines.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Adult Wellbeing Scale
Anxiety
|
6.3 Scores on a scale
n=5 Participants
|
6.78 Scores on a scale
n=7 Participants
|
5.36 Scores on a scale
n=5 Participants
|
5.94 Scores on a scale
n=4 Participants
|
|
Adult Wellbeing Scale
Depression
|
7.0 Scores on a scale
n=5 Participants
|
6.0 Scores on a scale
n=7 Participants
|
5.0 Scores on a scale
n=5 Participants
|
5.87 Scores on a scale
n=4 Participants
|
|
Adult Wellbeing Scale
Outward directed irritability
|
4.8 Scores on a scale
n=5 Participants
|
3.11 Scores on a scale
n=7 Participants
|
3.09 Scores on a scale
n=5 Participants
|
3.65 Scores on a scale
n=4 Participants
|
|
Adult Wellbeing Scale
Inward directed irritability
|
2.8 Scores on a scale
n=5 Participants
|
2.33 Scores on a scale
n=7 Participants
|
2.27 Scores on a scale
n=5 Participants
|
2.45 Scores on a scale
n=4 Participants
|
|
Edinburgh Postnatal Depression Scale (EPDS)
|
14.10 Scores on a scale
n=5 Participants
|
11 Scores on a scale
n=7 Participants
|
9.27 Scores on a scale
n=5 Participants
|
11.19 Scores on a scale
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
25.2 years
STANDARD_DEVIATION 5.391 • n=5 Participants
|
28.89 years
STANDARD_DEVIATION 8.594 • n=7 Participants
|
29 years
STANDARD_DEVIATION 7.851 • n=5 Participants
|
27.14 years
STANDARD_DEVIATION 7.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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),
Outcome measures
| Measure |
Mellow Bumps + Care as Usual
n=7 Participants
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
n=6 Participants
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.
|
Care as Usual
n=10 Participants
All participants received care in line with local guidelines.
|
|---|---|---|---|
|
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Depression
|
6.57 Scores on a scale
Full Range 3.309 • Interval 4.0 to 13.0
|
4.67 Scores on a scale
Full Range 2.658 • Interval 1.0 to 8.0
|
5.50 Scores on a scale
Full Range 2.915 • Interval 2.0 to 10.0
|
|
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Anxiety
|
5.29 Scores on a scale
Full Range 2.563 • Interval 3.0 to 10.0
|
3.17 Scores on a scale
Full Range 2.714 • Interval 0.0 to 8.0
|
4.60 Scores on a scale
Full Range 4.061 • Interval 0.0 to 11.0
|
|
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Outward directed irritability
|
3.86 Scores on a scale
Full Range 2.854 • Interval 1.0 to 9.0
|
2.00 Scores on a scale
Full Range 1.265 • Interval 0.0 to 3.0
|
2.80 Scores on a scale
Full Range 2.251 • Interval 0.0 to 7.0
|
|
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Inward directed irritability
|
2.14 Scores on a scale
Full Range 1.574 • Interval 0.0 to 4.0
|
0.83 Scores on a scale
Full Range 0.753 • Interval 0.0 to 2.0
|
1.20 Scores on a scale
Full Range 1.814 • Interval 0.0 to 6.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mellow Bumps + Care as Usual
n=7 Participants
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
n=6 Participants
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.
|
Care as Usual
n=10 Participants
All participants received care in line with local guidelines.
|
|---|---|---|---|
|
Depression Measured on EPDS
|
10.71 scores on a scale
Full Range 4.957 • Interval 7.0 to 20.0
|
4.83 scores on a scale
Full Range 3.251 • Interval 1.0 to 10.0
|
7.90 scores on a scale
Full Range 6.887 • Interval 0.0 to 19.0
|
PRIMARY outcome
Timeframe: 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),
Outcome measures
| Measure |
Mellow Bumps + Care as Usual
n=9 Participants
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
n=5 Participants
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.
|
Care as Usual
n=9 Participants
All participants received care in line with local guidelines.
|
|---|---|---|---|
|
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Depression
|
3.44 scores on a scale
Full Range 1.878 • Interval 0.0 to 6.0
|
3.44 scores on a scale
Full Range 2.345 • Interval 1.0 to 7.0
|
5.14 scores on a scale
Full Range 4.259 • Interval 1.0 to 10.0
|
|
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Anxiety
|
3.56 scores on a scale
Full Range 1.944 • Interval 0.0 to 6.0
|
2.80 scores on a scale
Full Range 4.087 • Interval 0.0 to 10.0
|
4.00 scores on a scale
Full Range 4.822 • Interval 0.0 to 11.0
|
|
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Outward directed irritability
|
2.00 scores on a scale
Full Range 1.936 • Interval 0.0 to 6.0
|
1.60 scores on a scale
Full Range 1.140 • Interval 0.0 to 3.0
|
2.89 scores on a scale
Full Range 2.028 • Interval 0.0 to 5.0
|
|
Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale
Inward directed irritability
|
0.89 scores on a scale
Full Range 1.269 • Interval 0.0 to 3.0
|
0.80 scores on a scale
Full Range 1.789 • Interval 0.0 to 4.0
|
0.67 scores on a scale
Full Range 1.118 • Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mellow Bumps + Care as Usual
n=9 Participants
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
n=5 Participants
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.
|
Care as Usual
n=9 Participants
All participants received care in line with local guidelines.
|
|---|---|---|---|
|
Depression Measured on EPDS
|
5.22 scores on a scale
Full Range 2.906 • Interval 0.0 to 10.0
|
2.80 scores on a scale
Full Range 4.147 • Interval 0.0 to 10.0
|
5.56 scores on a scale
Full Range 6.146 • Interval 0.0 to 16.0
|
Adverse Events
Mellow Bumps + Care as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chill-out in Pregnancy + Care as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Care as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place