Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000102673
Ethics application status
Approved
Date submitted
12/01/2023
Date registered
30/01/2023
Date last updated
30/01/2023
Date data sharing statement initially provided
30/01/2023
Date results provided
30/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bringing Baby Home Down Under. A replication of Shapiro & Gottman's original 2005 Randomised Control Study, trialed in an Australian population with 8-10 year follow-up.
Scientific title
Trialing effectiveness of the Gottman Institute's “Bringing Baby Home” program with Australian expectant parents using the Derogatis Symptom Check List 90 (SCL-90) and elements of the Locke-Wallace Relationship Assessment tool.

Secondary ID [1] 308748 0
None
Universal Trial Number (UTN)
U1111-1287-0090
Trial acronym
Linked study record
Shapiro AF, Gottman JM. Effects on Marriage of a Psycho-Communicative-Educational Intervention With Couples Undergoing the Transition to Parenthood, Evaluation at 1-Year Post Intervention. Journal of Family Communication (2005) 5(1) 1-24 doi.org/10.1207/s15327698jfc0501_1

Health condition
Health condition(s) or problem(s) studied:
Antenatal Education 328741 0
promoting positive transition to parenthood 328769 0
Condition category
Condition code
Reproductive Health and Childbirth 325700 325700 0 0
Antenatal care
Reproductive Health and Childbirth 325769 325769 0 0
Childbirth and postnatal care
Mental Health 325770 325770 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Bringing Baby Home Down Under.

The study is a randomised control, performed as an attempted partial replication and extension of Shapiro & Gottman (2005) doi.org/10.1207/s15327698jfc0501_1,

It examined outcomes from ‘Bringing Baby Home’, a psychosocial workshop designed for expectant couples.
Participants were recruited from attendees at an Australian suburban general hospital antenatal service. There were no exclusion criteria.
Outcomes were measured using 2 of the 3 self-report surveys used in the original study.
The original study also video-taped and coded participant couple interactions. The current study did not have the expertise or resourcing to do this.

After recruitment, couples were randomised to ‘Workshop’ or ‘Control’.
Data was examined as three groups, ‘Workshop’, ‘Control’ and ‘Intermediate’.
The 'Intermediate’ group comprises couples who were randomised to ‘Workshop’ but did not complete it.
18 Workshops were delivered monthly over 2 years, each as 2 x 6-7 hour sessions on consecutive Saturdays in a face-to-face group format, with up to 9 couples and a facilitator.
All workshops were delivered by the same facilitator, a midwife and antenatal educator with over 20 years experience.
As suggested by the developers, the workshops were delivered to couples in third trimester.

The workshop is designed as 18 modules. Each opens with a brief didactic overview of its topic area, followed by one or two interactive exercises conducted within couples. A number of the modules are also supported by short videos. The content is 'health-focused' rather than 'problem-focused'. The majority of the modules relate to communication, emotional engagement and regulation, and negotiation. Each concept is anchored in both parent-parent and parent-infant relationships, with delivery including an outline of a normal infant's needs and developing capacities. There are some additional topics (eg, established mitigating factors for post-partum depression, the value of engaged fathers).

The facilitator had completed the 3-day facilitator training run by the workshop designers, and had 12 months experience delivering workshop content prior to the study.

The workshops were supported by the materials purchased from the Gottman Institute, who developed the workshop. These included the instructor manual, supporting videos, and participant workbooks.

As an efficacy study:
-no assessment of fidelity was conducted.
-there was no formal 'personalisation' of the intervention, however from time to time the facilitator varied the time allocated to particular modules depending on group engagement and participation.

The original study concluded follow-up at 12 months post-birth.
the current study extends this out to 8-10 years.
Intervention code [1] 325207 0
Lifestyle
Intervention code [2] 325256 0
Behaviour
Comparator / control treatment
Participants randomised to both ‘workshop’ and ‘control’ groups had access to the standard ante-natal care classes offered by the hospital during the study.
These were offered as 7 x 2 hour weekday evening group sessions:
1 x first Trimester “welcome to pregnancy”,
1 x 1st-2nd trimester musculoskeletal class, run by Physiotherapy
(This class provided 1) general education on typical musculoskeletal changes and discomforts associated with pregnancy, along with advice on posture, stretches and massage techniques to address these and indications to seek physio review, 2) introduced pelvic floor exercises and recommended they be performed thrice daily, and 3) guidance around what constitutes low-to-moderate exercise intensities safe for pregnancy)
2 x 2nd trimester classes, providing didactic presentation of elements from 5 of the BBH workshop modules ('the transition', highlighting the typical extent of the life changes for western parents following birth of their first child; the importance in maintaining open communication; factors mitigating Post-Natal Depression;. the value of involved fathers; and two elements from the emotional regulation content- the infant quiet-alert state, and recognising parental flooding, and the importance of de-escalating that).

3 x 3rd trimester covering peripartum & lactation.
Control group
Active

Outcomes
Primary outcome [1] 333553 0
Change in Derogatis Symptom-Check-List 90 (SCL-90) 'Global Symptom Index' (GSI), a measure of overall psychological distress.
Timepoint [1] 333553 0
12 months post-birth
Primary outcome [2] 333554 0
Change in SCL-90 Anger subscale.
Timepoint [2] 333554 0
12 months post-birth
Primary outcome [3] 333555 0
Change in 6-item subset of Locke-Wallace Relationship Marital Adjustment Score (LW-6), as used in doi.org/10.1207/s15327698jfc0501_1
Timepoint [3] 333555 0
12 month post-birth
Secondary outcome [1] 417496 0
SCL-90 GSI, a measure of overall psychological distress
Timepoint [1] 417496 0
3 months post birth, 2 years post birth & 8-10 years post-birth
Secondary outcome [2] 417497 0
SCL-90 Depression subscales
Timepoint [2] 417497 0
3 months post-birth, 12 months post-birth, 2 years post-birth & 8-10 years post-birth
Secondary outcome [3] 417498 0
Full Locke-Wallace Marital Adjustment Score
Timepoint [3] 417498 0
3 months post-birth, 12 months post-birth, 2 years post-birth & 8-10 years post-birth
Secondary outcome [4] 417771 0
SCL-Anger Subscale
Timepoint [4] 417771 0
3 months post-birth, 2 years post-birth & 8-10 years post-birth
Secondary outcome [5] 417772 0
LW-6 (subset of Locke Wallace Marital Adjustment tool items exploring relationship satisfaction)
Timepoint [5] 417772 0
3 months post-birth, 2 years post-birth & 8-10 years post-birth.
Secondary outcome [6] 417773 0
SCL-90 Anxiety subscale
Timepoint [6] 417773 0
3 months post-birth, 1 year post-birth, 2 years post-birth, 8-10 years post-birth

Eligibility
Key inclusion criteria
Inclusion criteria:
Expectant couples.
Recruitment was initially via the Calvary Public Hospital Bruce Ante-natal Clinic.
As the study progressed, it transpired that potential participant couples were being informed by word-of-mouth, but not necessarily registered with the Calvary Public Hospital Bruce Ante-natal Clinic.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
As an effectiveness/'real-world' study, there were no exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
YES: sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Study-size was determined by simple power calculation pre-recruitment, assuming a moderate effect size of 0.5, power of 0.8 and significance=0.05 gave study size of 126.
Recruitment was closed at 122 participants as
1) this was approaching the study size estimate, and
2) preliminary analysis of available 12 month data suggested an effect.

The original plan was that one of the authors would analyse the data using repeated-measures Analysis of Variance (rm ANOVA), as had been done in the original study..
However, once acquired it became clear the data-set violated assumptions of an rm ANOVA approach, and was beyond the technical expertise of the authors to analyse appropriately.

Linear mixed effects modelling was used as primary analysis for primary endpoints plus the 2 year secondary timepoint for Control and Workshop.
Linear mixed effects modelling with inclusion of either the ‘intermediate’ group, or the 3 month or ‘Late’ timepoints was non-convergent..
Accordingly, data for secondary endpoints at 3 months and 8-10 years and comparisons of Workshop and Control with the 'intermetediate' group at all timepoints was examined using ANOVA.

A separate secondary Bayesian analysis was also conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/01/2009
Date of last participant enrolment
Anticipated
Actual
29/09/2010
Date of last data collection
Anticipated
Actual
30/11/2018
Sample size
Target
126
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 23823 0
Calvary Public Hospital ACT - Bruce
Recruitment postcode(s) [1] 39277 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 312968 0
Government body
Name [1] 312968 0
ACT Health
Country [1] 312968 0
Australia
Funding source category [2] 312970 0
Hospital
Name [2] 312970 0
Calvary Public Hospital Bruce,
Country [2] 312970 0
Australia
Funding source category [3] 312971 0
Self funded/Unfunded
Name [3] 312971 0
Jamie Alan christie
Country [3] 312971 0
Australia
Primary sponsor type
Individual
Name
Jamie Christie
Address
Senior Staff Specialist, Calvary Public Hospital Bruce, ACT 2617

PO Box 6112, O'Connor ACT 2602
Country
Australia
Secondary sponsor category [1] 314658 0
None
Name [1] 314658 0
Address [1] 314658 0
Country [1] 314658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312240 0
Calvary Public Hospital BRUCE HREC
Ethics committee address [1] 312240 0
Ethics committee country [1] 312240 0
Australia
Date submitted for ethics approval [1] 312240 0
14/08/2008
Approval date [1] 312240 0
08/10/2008
Ethics approval number [1] 312240 0
17-2008; subsequently 26-2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123954 0
Dr jamie christie
Address 123954 0
Senior Staff Specialist, Calvary Public Hospital Bruce ACT 2617

PO Box 6112, O'Connor ACT
Country 123954 0
Australia
Phone 123954 0
+61429002774
Fax 123954 0
Email 123954 0
[email protected]
Contact person for public queries
Name 123955 0
jamie christie
Address 123955 0
Senior Staff Specialist, Calvary Public Hospital Bruce ACT 2617

PO Box 6112, O'Connor ACT
Country 123955 0
Australia
Phone 123955 0
+61429002774
Fax 123955 0
Email 123955 0
[email protected]
Contact person for scientific queries
Name 123956 0
jamie christie
Address 123956 0
Senior Staff Specialist, Calvary Public Hospital Bruce ACT 2617

PO Box 6112, O'Connor ACT
Country 123956 0
Australia
Phone 123956 0
+61429002774
Fax 123956 0
Email 123956 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
line-by-line participant data
linear mixed effects modeling code
When will data be available (start and end dates)?
data will be available once study has ANZCTR ID.
no current plan to have end-date on data-availability
Available to whom?
data available to anyone who wishes
Available for what types of analyses?
any purpose
How or where can data be obtained?
intention is that data will be logged on the DRYAD data-base (https://datadryad.org/)
once ANZCTR ID has been issued.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18038Other    will be accessible through DRYAD once ANZCTR ID is... [More Details]
18092Analytic code    will be accessible through DRYAD once ANZCTR ID is... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.