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Trial registered on ANZCTR


Registration number
ACTRN12615000684527
Ethics application status
Approved
Date submitted
17/06/2015
Date registered
1/07/2015
Date last updated
19/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An effect of antenatal and postnatal maternal support programs on attachment and resilience for mums and infants: A Randomised Controlled Trial.
Scientific title
An effect of antenatal and postnatal maternal support programs on mental health and mother-infant attachment in comparison to standard care in pregnant women at risk for mental illness: A Randomised Controlled Trial.
Secondary ID [1] 286886 0
Nil
Universal Trial Number (UTN)
Trial acronym
BEAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 295308 0
Anxiety 295309 0
Personality Disorders 295310 0
Substance Dependence 295311 0
Psychosis 295312 0
Condition category
Condition code
Mental Health 295580 295580 0 0
Depression
Mental Health 295581 295581 0 0
Anxiety
Reproductive Health and Childbirth 295582 295582 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The population of interest for this study are expectant women booked to deliver at the Royal Women's Hospital who are referred to the mental health services.This will be a randomised controlled trial (RCT) with four arms. Participants in three arms will receive an intervention. The fourth arm will be the control group. Progress through the different phases of the trial will be based on the Consolidated Standards of Reporting Trials (CONSORT) recommendations for RCTs.
During pregnancy (antenatal period) one-half (n=250) of participants (Groups 1 and 3) will receive a mindfulness-based intervention in addition to treatment as usual (TAU) and the other half (n=250) will receive TAU only (Groups 2 and 4). Two months following birth (postnatal period), participants in Groups 1 and 2 with receive an attachment-based intervention in addition to TAU and Groups 3 and 4 will receive TAU only.
The interventions are:


1. Antenatal mindfulness intervention aimed at addressing maternal anxiety, depression and stress. The intervention comprises of five weekly sessions, with each session of 2hrs and 15mins duration. The intervention will be delivered by mental health and health professionals (e.g., psychologists, midwives and maternal and child health care nurses) who have been trained and supervised by Dr Mercuri.

2. Postnatal attachment-focused intervention focused on infant-parent interactional coaching and improving parental reflective capacity. The intervention comprises of 10 weekly sessions, with each session of 1.5-2 hours duration. The first session will take place approximately 2 months post delivery. The intervention will be delivered by mental health and health professionals (e.g., psychologists, maternal and child health care nurses) who have been trained and supervised by Prof. Newman.


Adherence to the interventions will be monitored via an attendance registry.
Intervention code [1] 292169 0
Behaviour
Intervention code [2] 292227 0
Treatment: Other
Comparator / control treatment
The control group will receive treatment as usual (TAU), which will involve the standard care provided to all parents presenting at the antenatal and postnatal services at the Royal Women's Hospital. Standard care may involve regular therapy sessions with a mental health professional and/or medication, depending on the needs of the individual.
Control group
Active

Outcomes
Primary outcome [1] 295294 0
1. Maternal mental health and psychosocial functioning, as measured by the following questionnaires:

- Pregnancy Related Anxiety Questionnaire- Revised
- Spielberger State-Trait Inventory
- Centre for Epidemiological Depression Scale
Timepoint [1] 295294 0
Pregnancy Related Anxiety Questionnaire- Revised; at Baseline (upon entry into the study), 20, 28 & 36 weeks gestation.

Spielberger State-Trait Inventory; at all 10 timepoints (at Baseline, 20 weeks, 28 weeks, 30 weeks gestation, Birth, 6 months, 12 months, 18 months, 24 months and 36 months).

Centre for Epidemiological Depression Scale; at all 10 timepoints (at Baseline, 20 weeks, 28 weeks, 30 weeks gestation, Birth, 6 months, 12 months, 18 months, 24 months and 36 months).
Primary outcome [2] 295295 0
2. Maternal parenting, attachment and mother-infant interaction, as measured by the following;

-Emotional Availability Scale
-Strange Situation Procedure
Timepoint [2] 295295 0
-Emotional Availability Scale; at 6 and 12 months post-birth
-Strange Situation Procedure; at 12 and 24 months post-birth
Primary outcome [3] 295296 0
Infant Development, as measured by the following:

- Fetal heart rate (CTG)
- Bayley Scales of Infant Development
- Psychoeducational Profile (3rd ed.)
Timepoint [3] 295296 0
Fetal heart rate (CTG): at 28 and 36 weeks gestation- Bayley Scales of Infant Development; at 6 months post birth -Psychoeducational Profile; at 18 and 36 months post-birth
Secondary outcome [1] 315276 0
Parental Knowledge of Infant Development, as measured by the Newborn Developmental Knowledge Questionnaire.
Timepoint [1] 315276 0
Baseline and 12 months

Eligibility
Key inclusion criteria
*Have basic English literacy and communication skills to enable them to participate in the assessment and intervention processes;
*Receiving antenatal care and booked to deliver at the Royal Women's Hospital
*Up to 2nd trimester
*Considered ‘at risk’, where 'at risk' includes women who have a current or past personal or family (first degree relatives only) history of any mental illness including symptoms of anxiety and depression, and/or have current psychosocial stressors (e.g., poor social support, unstable accommodation, intimate partner violence, contact with Department of Human Services Protective Services).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
*Acute psychosis
*Uncontrolled drug abuse
*A level of intellectual disability which will prevent the woman from understanding and communicating sufficiently to participate in the assessment and intervention processes
*a known serious medical illness which will preclude participation
*major depression requiring hospitalisation or precluding them from participating
*Child removed from parental care (mother not primary attachment figure)
*Already engaged in a parenting or meditative program that is therapeutic in nature

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/07/2015
Actual
24/08/2015
Date of last participant enrolment
Anticipated
29/05/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3930 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 9847 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 291481 0
Charities/Societies/Foundations
Name [1] 291481 0
The Mental Health Foundation of Australia
Country [1] 291481 0
Australia
Funding source category [2] 291482 0
Charities/Societies/Foundations
Name [2] 291482 0
The Pratt Foundation
Country [2] 291482 0
Australia
Primary sponsor type
Individual
Name
Professor Louise Newman
Address
Centre for Women's Mental Health
The Royal Women's Hospital
cnr Grattan St and Flemington Road
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 290161 0
Individual
Name [1] 290161 0
Professor Ian Everall
Address [1] 290161 0
Department of Psychiatry
Main Block, L1 North,
Royal Melbourne Hospital
Parkville, VIC 3050
Country [1] 290161 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293028 0
The Royal Women's Hospital Research and Human Research Ethics Commitees
Ethics committee address [1] 293028 0
Ethics committee country [1] 293028 0
Australia
Date submitted for ethics approval [1] 293028 0
Approval date [1] 293028 0
27/04/2015
Ethics approval number [1] 293028 0
15/04

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

Contacts
Principal investigator
Name 57974 0
Prof Louise Newman
Address 57974 0
Centre for Women's Mental Health, The Royal Women's Hospital, Cnr Grattan St & Flemington Rd, Parkville VIC 3052
Country 57974 0
Australia
Phone 57974 0
+61 3 83452070
Fax 57974 0
Email 57974 0
[email protected]
Contact person for public queries
Name 57975 0
Angela Komiti
Address 57975 0
Level 1 North, Main Block, Royal Melbourne Hospital, Grattan Street, Parkville VIC 3050
Country 57975 0
Australia
Phone 57975 0
+61 3 90357122
Fax 57975 0
Email 57975 0
[email protected]
Contact person for scientific queries
Name 57976 0
Angela Komiti
Address 57976 0
Level 1 North, Main Block, Royal Melbourne Hospital, Grattan Street, Parkville VIC 3050
Country 57976 0
Australia
Phone 57976 0
+61 3 90357122
Fax 57976 0
Email 57976 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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