Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 302132 | Other Identifier | IRAS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| South London and Maudsley NHS Foundation Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to test a group for pregnant women with depression that aims to help them build a stronger relationship with their unborn baby. The main questions it aims to answer are:
Participants will be asked to:
Depression during pregnancy is a common mental health problem. Pregnant women with depression often continue to feel depressed after their baby is born, which can have several negative effects for both mother and child. For example, depressed mothers can find it harder to build a good relationship with their baby. Existing treatments for depression may not be sufficient to also improve the relationship between mother and baby. Depressed mothers may therefore need more specific help with connecting to their baby.
One promising new intervention is Baby CHAT. Baby CHAT is a single-session group that helps expectant parents learn about their unborn baby by viewing moving 4D ultrasound scans. It is believed that this will help parents to build a stronger relationship with their unborn baby. Baby CHAT has already been trialled with parents without any mental health problems, with promising results. This study aims to assess whether Baby CHAT is helpful for pregnant women with depression, collect data to inform future large-scale trials, and to develop the intervention from participants' feedback. The main research question asks: is Baby CHAT acceptable and feasible to deliver with pregnant women with depression?
Participants eligible to take part in the project will be people aged ≥18 years who are pregnant, between 20- and 34-weeks' gestation, and currently experiencing depressive symptoms. The project is taking place at an NHS site, with participants recruited from mental health and maternity services and online advertising. Participants will attend an online Baby CHAT group and complete online questionnaires at three time points (before and after Baby CHAT, and at one-month follow-up). The questionnaires will assess participants' relationship with their unborn baby, their ability to imagine their unborn baby as a separate person, and their level of depressive symptoms. The anticipated study end date is May 2023.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Single-session 90-minute psychoeducational group ("Baby CHAT") delivered antenatally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baby CHAT | Other | Baby CHAT is an approximately 90-minute group intervention to be delivered during pregnancy. The group is comprised of psychoeducational material about a baby's social development after birth and while the baby is growing in the womb. Attendees are encouraged to think about when an infant's social development begins and consider whether this occurs before or after birth. Participants are then shown a video clip of Reissland et al.'s (2016) study showing 4D ultrasound images of foetuses mouthing in response to sounds that are presented to them outside the womb. During Baby CHAT, parents are encouraged to reflect on this information in the context of their own baby's development, including their likes and dislikes, routine and personality. The final section of the group involves generating ideas for social activities that parents can try with their baby prior to birth, such as singing to, massaging or reading to their baby. |
| Measure | Description | Time Frame |
|---|---|---|
| Change on Maternal Antenatal Attachment Scale (MAAS) | The Maternal Antenatal Attachment Scale (MAAS; Condon, 1993) is a self-report questionnaire for expectant mothers, designed to assess the maternal-foetal attachment during pregnancy. The scale consists of 19 items on a 5-point Likert scale assessing women's attitudes, feelings and behaviours towards their foetus. Higher total scores indicate stronger prenatal bonding i.e. a better outcome (range 19-95). | Baseline, up to 48-hours post-intervention, 1-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ) | The Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ; Pajulo et al., 2015) is a 14-item self-report questionnaire assessing expectant parents' abilities to think of their foetus as a separate individual with a developing temperament, personality and needs. The scale can be used during the second and third trimester of pregnancy. Higher total scores indicate stronger prenatal parental reflective functioning i.e. a better outcome (range 14-98). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebecca C Cockburn | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | London | SE5 8AF | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Single-session 90-minute psychoeducational group ("Baby CHAT") delivered antenatally. Baby CHAT: Baby CHAT is an approximately 90-minute group intervention to be delivered during pregnancy. The group is comprised of psychoeducational material about a baby's social development after birth and while the baby is growing in the womb. Attendees are encouraged to think about when an infant's social development begins and consider whether this occurs before or after birth. Participants are then shown a video clip of Reissland et al.'s (2016) study showing 4D ultrasound images of foetuses mouthing in response to sounds that are presented to them outside the womb. During Baby CHAT, parents are encouraged to reflect on this information in the context of their own baby's development, including their likes and dislikes, routine and personality. The final section of the group involves generating ideas for social activities that parents can try with their baby prior to birth, such as singing to, massaging or reading to their baby. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Single-session 90-minute psychoeducational group ("Baby CHAT") delivered antenatally. Baby CHAT: Baby CHAT is an approximately 90-minute group intervention to be delivered during pregnancy. The group is comprised of psychoeducational material about a baby's social development after birth and while the baby is growing in the womb. Attendees are encouraged to think about when an infant's social development begins and consider whether this occurs before or after birth. Participants are then shown a video clip of Reissland et al.'s (2016) study showing 4D ultrasound images of foetuses mouthing in response to sounds that are presented to them outside the womb. During Baby CHAT, parents are encouraged to reflect on this information in the context of their own baby's development, including their likes and dislikes, routine and personality. The final section of the group involves generating ideas for social activities that parents can try with their baby prior to birth, such as singing to, massaging or reading to their baby. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change on Maternal Antenatal Attachment Scale (MAAS) | The Maternal Antenatal Attachment Scale (MAAS; Condon, 1993) is a self-report questionnaire for expectant mothers, designed to assess the maternal-foetal attachment during pregnancy. The scale consists of 19 items on a 5-point Likert scale assessing women's attitudes, feelings and behaviours towards their foetus. Higher total scores indicate stronger prenatal bonding i.e. a better outcome (range 19-95). | N=4 delivered their babies by Time 3 and therefore did not complete the MAAS at this timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, up to 48-hours post-intervention, 1-month follow-up |
|
4 weeks after attending intervention
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Single-session 90-minute psychoeducational group ("Baby CHAT") delivered antenatally. Baby CHAT: Baby CHAT is an approximately 90-minute group intervention to be delivered during pregnancy. The group is comprised of psychoeducational material about a baby's social development after birth and while the baby is growing in the womb. Attendees are encouraged to think about when an infant's social development begins and consider whether this occurs before or after birth. Participants are then shown a video clip of Reissland et al.'s (2016) study showing 4D ultrasound images of foetuses mouthing in response to sounds that are presented to them outside the womb. During Baby CHAT, parents are encouraged to reflect on this information in the context of their own baby's development, including their likes and dislikes, routine and personality. The final section of the group involves generating ideas for social activities that parents can try with their baby prior to birth, such as singing to, massaging or reading to their baby. |
Not provided
Not provided
As this was a small, uncontrolled feasibility study, it is not possible to conclude that any observed changes in prenatal bonding, parental RF or depressive symptomatology were due to the intervention. Future research is needed with larger sample sizes, powered to test for statistically significant changes, and utilising a control condition. A comparison group would allow for greater control of confounding variables.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Rebecca Cockburn | King's College London/South London and Maudsley NHS | 02032288800 | rebecca.cockburn@kcl.ac.uk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2022 | Aug 7, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Single-arm repeated measures
Not provided
Not provided
Not provided
Not provided
|
| Baseline, up to 48-hours post-intervention, 1-month follow-up |
| Change on Edinburgh Postnatal Depression Scale (EPDS) | The Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden & Sagovsky, 1987) is a 10-item self-report measure used to identify depression in women during the perinatal period. The scale was initially developed to screen for postnatal depression but has also been validated for use in antenatal populations (Murray & Cox, 1990). Higher total scores indicate higher presence of depressive symptoms i.e. a worse outcome (range 0-30). | Baseline, up to 48-hours post-intervention, 1-month follow-up |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Gestational age at baseline | Mean | Standard Deviation | weeks |
|
|
|
|
| Secondary | Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ) | The Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ; Pajulo et al., 2015) is a 14-item self-report questionnaire assessing expectant parents' abilities to think of their foetus as a separate individual with a developing temperament, personality and needs. The scale can be used during the second and third trimester of pregnancy. Higher total scores indicate stronger prenatal parental reflective functioning i.e. a better outcome (range 14-98). | N=1 delivered their baby before fully completing Time 2 and a total N=4 had delivered their babies by Time 3, therefore not completing the P-PRFQ. | Posted | Mean | Standard Deviation | score on a scale | Baseline, up to 48-hours post-intervention, 1-month follow-up |
|
|
|
|
| Secondary | Change on Edinburgh Postnatal Depression Scale (EPDS) | The Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden & Sagovsky, 1987) is a 10-item self-report measure used to identify depression in women during the perinatal period. The scale was initially developed to screen for postnatal depression but has also been validated for use in antenatal populations (Murray & Cox, 1990). Higher total scores indicate higher presence of depressive symptoms i.e. a worse outcome (range 0-30). | N=1 delivered their baby before fully completing Time 2 and therefore did not complete the EPDS at Time 2 or 3. The N=3 who delivered their babies between Time 2 and Time 3 (and therefore did not complete the MAAS and P-PRFQ) still completed the EPDS at Time 3, as it is appropriate to be used in the postnatal period. | Posted | Mean | Standard Deviation | score on a scale | Baseline, up to 48-hours post-intervention, 1-month follow-up |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided
Not provided
|
| Time 3 (1-month follow-up) |
|
|
| Effect size (Hedge's g) |
| 0.49 |
| 2-Sided |
| 95 |
| -0.20 |
| 1.17 |
| Other |
|
| Time 3 (1-month follow-up) |
|
|
| Effect size (Hedge's g) |
| 2.08 |
| 2-Sided |
| 95 |
| 1.28 |
| 2.88 |
| Other |