Mental Health Wellness 1, Mother-Child Relations, Pregnancy
Conditions
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.
Interventions
OTHERMellow Bumps
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.
OTHERChill-out in Pregnancy
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.
Sponsors
Scottish Collaboration for Public Health Research and Policy
University of Glasgow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | 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 | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 9 |
| Care as Usual (CAU) Participants received care in line with local guidelines. | 12 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Care as Usual (CAU) | Chill-out in Pregnancy (CHiP) + Care as Usual | Mellow Bumps (MB) + Care as Usual |
|---|---|---|---|---|
| Adult Wellbeing Scale Anxiety | 5.94 Scores on a scale | 5.36 Scores on a scale | 6.78 Scores on a scale | 6.3 Scores on a scale |
| Adult Wellbeing Scale Depression | 5.87 Scores on a scale | 5.0 Scores on a scale | 6.0 Scores on a scale | 7.0 Scores on a scale |
| Adult Wellbeing Scale Inward directed irritability | 2.45 Scores on a scale | 2.27 Scores on a scale | 2.33 Scores on a scale | 2.8 Scores on a scale |
| Adult Wellbeing Scale Outward directed irritability | 3.65 Scores on a scale | 3.09 Scores on a scale | 3.11 Scores on a scale | 4.8 Scores on a scale |
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 12 Participants | 8 Participants | 10 Participants |
| Age, Continuous | 27.14 years STANDARD_DEVIATION 7.49 | 29 years STANDARD_DEVIATION 7.851 | 28.89 years STANDARD_DEVIATION 8.594 | 25.2 years STANDARD_DEVIATION 5.391 |
| Edinburgh Postnatal Depression Scale (EPDS) | 11.19 Scores on a scale | 9.27 Scores on a scale | 11 Scores on a scale | 14.10 Scores on a scale |
| Region of Enrollment United Kingdom | 31 participants | 12 participants | 9 participants | 10 participants |
| Sex: Female, Male Female | 31 Participants | 12 Participants | 9 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 9 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 | 0 / 14 |
Outcome results
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),
Time frame: Post intervention (approximately 9-12 weeks after baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mellow Bumps + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Depression | 6.57 Scores on a scale | Full Range 3.309 |
| Mellow Bumps + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Anxiety | 5.29 Scores on a scale | Full Range 2.563 |
| Mellow Bumps + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Outward directed irritability | 3.86 Scores on a scale | Full Range 2.854 |
| Mellow Bumps + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Inward directed irritability | 2.14 Scores on a scale | Full Range 1.574 |
| Chill-out in Pregnancy + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Inward directed irritability | 0.83 Scores on a scale | Full Range 0.753 |
| Chill-out in Pregnancy + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Depression | 4.67 Scores on a scale | Full Range 2.658 |
| Chill-out in Pregnancy + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Outward directed irritability | 2.00 Scores on a scale | Full Range 1.265 |
| Chill-out in Pregnancy + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Anxiety | 3.17 Scores on a scale | Full Range 2.714 |
| Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Inward directed irritability | 1.20 Scores on a scale | Full Range 1.814 |
| Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Anxiety | 4.60 Scores on a scale | Full Range 4.061 |
| Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Outward directed irritability | 2.80 Scores on a scale | Full Range 2.251 |
| Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Depression | 5.50 Scores on a scale | Full Range 2.915 |
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),
Time frame: Post-birth (8-12 weeks postnatal)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mellow Bumps + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Outward directed irritability | 2.00 scores on a scale | Full Range 1.936 |
| Mellow Bumps + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Inward directed irritability | 0.89 scores on a scale | Full Range 1.269 |
| Mellow Bumps + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Anxiety | 3.56 scores on a scale | Full Range 1.944 |
| Mellow Bumps + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Depression | 3.44 scores on a scale | Full Range 1.878 |
| Chill-out in Pregnancy + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Depression | 3.44 scores on a scale | Full Range 2.345 |
| Chill-out in Pregnancy + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Anxiety | 2.80 scores on a scale | Full Range 4.087 |
| Chill-out in Pregnancy + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Inward directed irritability | 0.80 scores on a scale | Full Range 1.789 |
| Chill-out in Pregnancy + Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Outward directed irritability | 1.60 scores on a scale | Full Range 1.14 |
| Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Inward directed irritability | 0.67 scores on a scale | Full Range 1.118 |
| Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Depression | 5.14 scores on a scale | Full Range 4.259 |
| Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Anxiety | 4.00 scores on a scale | Full Range 4.822 |
| Care as Usual | Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale | Outward directed irritability | 2.89 scores on a scale | Full Range 2.028 |
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.
Time frame: Post-intervention (approximately 9 -12 weeks after baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mellow Bumps + Care as Usual | Depression Measured on EPDS | 10.71 scores on a scale | Full Range 4.957 |
| Chill-out in Pregnancy + Care as Usual | Depression Measured on EPDS | 4.83 scores on a scale | Full Range 3.251 |
| Care as Usual | Depression Measured on EPDS | 7.90 scores on a scale | Full Range 6.887 |
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.
Time frame: Post-birth (8-12 weeks postnatal)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mellow Bumps + Care as Usual | Depression Measured on EPDS | 5.22 scores on a scale | Full Range 2.906 |
| Chill-out in Pregnancy + Care as Usual | Depression Measured on EPDS | 2.80 scores on a scale | Full Range 4.147 |
| Care as Usual | Depression Measured on EPDS | 5.56 scores on a scale | Full Range 6.146 |