Trial Outcomes & Findings for A Prenatal Bonding Intervention for Pregnant Women With Depression (NCT NCT05628675)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Baseline, up to 48-hours post-intervention, 1-month follow-up

Results posted on

2025-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	21
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Prenatal Bonding Intervention for Pregnant Women With Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=20 Participants 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.
Age, Continuous	34.7 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Asian British	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or Black British	3 Participants n=5 Participants
Race/Ethnicity, Customized Mixed ethnic group	1 Participants n=5 Participants
Race/Ethnicity, Customized White or White British	13 Participants n=5 Participants
Race/Ethnicity, Customized Other ethnic group	2 Participants n=5 Participants
Gestational age at baseline	29.1 weeks STANDARD_DEVIATION 5.3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, up to 48-hours post-intervention, 1-month follow-up

Population: N=4 delivered their babies by Time 3 and therefore did not complete the MAAS at this timepoint.

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).

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants 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.
Change on Maternal Antenatal Attachment Scale (MAAS) Time 1 (pre-intervention)	69.7 score on a scale Standard Deviation 9.1
Change on Maternal Antenatal Attachment Scale (MAAS) Time 2 (up to 48-hours post-intervention)	72.4 score on a scale Standard Deviation 7.9
Change on Maternal Antenatal Attachment Scale (MAAS) Time 3 (1-month follow-up)	75.9 score on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: Baseline, up to 48-hours post-intervention, 1-month follow-up

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants 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.
Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ) Time 1 (pre-intervention)	60.7 score on a scale Standard Deviation 15.1
Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ) Time 2 (up to 48-hours post-intervention)	65.7 score on a scale Standard Deviation 11.7
Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ) Time 3 (1-month follow-up)	67.1 score on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: Baseline, up to 48-hours post-intervention, 1-month follow-up

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants 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.
Change on Edinburgh Postnatal Depression Scale (EPDS) Time 1 (pre-intervention)	17.3 score on a scale Standard Deviation 3.0
Change on Edinburgh Postnatal Depression Scale (EPDS) Time 2 (up to 48-hours post-intervention)	12.1 score on a scale Standard Deviation 4.0
Change on Edinburgh Postnatal Depression Scale (EPDS) Time 3 (1-month follow-up)	10.4 score on a scale Standard Deviation 3.6

Adverse Events

Intervention

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

Dr Rebecca Cockburn

King's College London/South London and Maudsley NHS

Phone: 02032288800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place