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Trial registered on ANZCTR


Registration number
ACTRN12618000491268
Ethics application status
Approved
Date submitted
22/03/2018
Date registered
4/04/2018
Date last updated
4/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding your Newborn and Adapting to parenthood (UNA): A randomised clinical effectiveness trial of the Newborn Behavioural Observations (NBO) for new families.
Scientific title
Understanding your Newborn and Adapting to parenthood (UNA): A randomised clinical effectiveness trial of the Newborn Behavioural Observations (NBO) on mother-infant relationship, and maternal postnatal depression and stress in new families at-risk of postnatal depression.
Secondary ID [1] 293361 0
Nil
Universal Trial Number (UTN)
U1111-1205-0985
Trial acronym
UNA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum Depression 305479 0
Condition category
Condition code
Mental Health 304734 304734 0 0
Depression
Mental Health 306285 306285 0 0
Anxiety
Reproductive Health and Childbirth 306286 306286 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, the intervention group (G2), will be offered three NBO sessions coinciding with episodes of routine post-natal care in the first month of parenthood (in addition to being offered treatment as usual (TAU) in the hospital or in the community for their mental health as required). Standard care may involve regular therapy sessions with a mental health professional and/or medication, depending on the needs of the individual.

The intervention will be delivered by a midwife who is an accredited NBO practitioner. Each NBO will be a structured session between clinician and family, consisting of 18 very brief, baby-led and baby-responsive, neuro-behavioural activities and observations, which reveal the infant’s capacities and behavioural adaptation from birth to the third month of life. Each visit for the NBO will take between 30 minutes to 1 hour depending on the baby due to feeding, sleeping etc. Each visit will be timed to coincide with the maternal child health (MCH) home visit when baby is 1-4 days old, and the 2 week and 4 week MCH clinic or home visit.

Adherence to the interventions will be monitored via a home visit registry. Fidelity to the intervention will be monitored by fortnightly supervision by an experienced NBO practitioner which will include reviewing a video recording of the second NBO session for all G2 families with the midwife. The midwife will also complete an NBO fidelity questionnaire at the end of every NBO session provided.
Intervention code [1] 299615 0
Prevention
Comparator / control treatment
Recruits randomized to clinical comparison group G1 will be offered referral for ‘treatment as usual' (TAU) for their mental health either through the hospital they are recruited from or within the community. Treatment as usual at the hospital involves allocation to a mental health team clinician depending on the history and the women’s preference for individual psychiatry or psychology care. Treatment within the community will also include individual psychiatry or psychology care via referral from a general practitioner.
Control group
Active

Outcomes
Primary outcome [1] 303947 0
1. Quality of mother-infant interaction will be assessed using an observational assessment called the Emotional Availability Scales (EAS). This will be a video recorded mother-infant play session at the home visit endpoint assessment and sent to be blind-coded by coder who is accredited in using the EAS.
Timepoint [1] 303947 0
At home visit 4 months post birth
Primary outcome [2] 303948 0
2. Diagnosis of postnatal depression as measured by the Structured Clinicial Interview for the DSM-5 (MDE module),
Timepoint [2] 303948 0
At home visit 4 months post birth
Primary outcome [3] 303949 0
3. Infant development assessed using the Bayley Scales of Infant and Toddler Development-III
Timepoint [3] 303949 0
At home visit at 4 months post birth
Secondary outcome [1] 340526 0
Primary Outcome 4: Symptoms of depression as measured by the Edinburgh Postnatal Depression Scale (EPDS)
Timepoint [1] 340526 0
At baseline, 6 weeks and 4 months post birth
Secondary outcome [2] 340528 0
Primary Outcome 5: Parenting stress as measured by the Parenting Stress Scale
Timepoint [2] 340528 0
At 4 months post birth
Secondary outcome [3] 344739 0
Acceptability and usefulness of the NBO for parents assessed using a parent feedback questionnaire created for this study
Timepoint [3] 344739 0
Administered following each NBO visit at 2 days, 2 weeks and 4 weeks post birth and at 6 weeks post birth
Secondary outcome [4] 344742 0
Psychosocial functioning as measured by the Antenatal Risk Questionnaire and Postnatal Risk Questionnaire
Timepoint [4] 344742 0
measured at baseline, and 4 months post birth.
Secondary outcome [5] 344743 0
Relationship satisfaction as measured by the Relationship Satisfaction Scale
Timepoint [5] 344743 0
36 weeks gestation and 4 months post birth
Secondary outcome [6] 344744 0
Parental reflective functioning as measured by the Prenatal Parental Reflective Functioning Questionnaire and Parental Reflective Functioning Questionnaire
Timepoint [6] 344744 0
36 weeks gestation and 4 months post birth
Secondary outcome [7] 344961 0
Parenting self-efficacy as measured by the Parental Self-efficacy Scale
Timepoint [7] 344961 0
At 4 months post birth
Secondary outcome [8] 344962 0
Infant Temperament as measured by the Parenting Stress Index PSI adaptability, distractibility and mood subscales
Timepoint [8] 344962 0
At 4 months post birth
Secondary outcome [9] 344963 0
Prenatal attachment as measured by the Prenatal Attachment Inventory, PAI
Timepoint [9] 344963 0
At 36 weeks gestation
Secondary outcome [10] 344964 0
Parental attachment as measure by the Parenting Stress Index - attachment subscale
Timepoint [10] 344964 0
At 4 months post birth

Eligibility
Key inclusion criteria
Women's eligibility will be ascertained in two stages: First during pregnancy where if eligible they will be recruited and screened and then at birth for all follow up after birth even if they have been randomised. The following eligibility criteria include:
During Pregnancy:
-Nulliparous
-Up to 36 weeks gestation
-Able to speak English and to respond to a written questionnaire
-Live within 40 minutes’ drive of the hospital from which they are recruited (RWH, Melbourne or Bendigo, VIC).
At Birth:
-Baby born at term without a severe disability;

During pregnancy, male partners will be eligible to participate if they are expectant first time fathers whose female partner has consented to take part in the study, if they are age 20 or more, and if they are able to speak and to respond to a written questionnaire in English.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
As above, women will be excluded from the study at two-stages: during pregnancy when recruitment occurs and at birth as per the criteria outlined below.
During pregnancy:
-Multiparous,
-If they are more than 36 weeks gestation,
-under the age of 20,
-if they are unable to speak or respond to a questionnaire in English,
-If they live more than 40 minutes’ drive from the hospital.

At birth:
if their baby is born <37 weeks gestation or with severe disability,

During pregnancy, partners will be excluded from this study if they are not male, if they are already fathers from a previous partner, if their partner declines to participate in the study or is excluded from the study, if they are under the age of 20, and if they are unable to speak and to respond to a written questionnaire in English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The project will test for significant differences between female recruits in the clinical comparison group (G1) and intervention groups (G2) in the main outcome variables of postnatal depression, stress symptoms and mother- infant relationship quality. ANCOVA analyses will test for between group differences in mother-infant interaction, maternal depression symptoms and maternal stress at infant age 4 months. Chi squared analysis will test for between group differences in the prevalence of maternal depression, diagnosed using the SCID-5 interview.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
10/08/2017
Date of last participant enrolment
Anticipated
Actual
31/03/2018
Date of last data collection
Anticipated
31/07/2018
Actual
Sample size
Target
150
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9394 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 9395 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 18094 0
3052 - Parkville
Recruitment postcode(s) [2] 18095 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 297983 0
Charities/Societies/Foundations
Name [1] 297983 0
Liptember Foundation
Country [1] 297983 0
Australia
Primary sponsor type
Individual
Name
Dr Susan Nicolson
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] 297051 0
None
Name [1] 297051 0
Address [1] 297051 0
Country [1] 297051 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299024 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 299024 0
Ethics committee country [1] 299024 0
Australia
Date submitted for ethics approval [1] 299024 0
Approval date [1] 299024 0
01/02/2016
Ethics approval number [1] 299024 0
15/30
Ethics committee name [2] 299026 0
Bendigo Health Care Group Human Research Ethics Committee
Ethics committee address [2] 299026 0
Ethics committee country [2] 299026 0
Australia
Date submitted for ethics approval [2] 299026 0
02/10/2017
Approval date [2] 299026 0
30/10/2017
Ethics approval number [2] 299026 0
HREC/17/BHCG/46

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

Contacts
Principal investigator
Name 79026 0
Dr Susan Nicolson
Address 79026 0
Centre for Women's Mental Health, The Royal Women's Hospital, Cnr Grattan St & Flemington Rd, Parkville VIC 3052
Country 79026 0
Australia
Phone 79026 0
+61 3 83452009
Fax 79026 0
Email 79026 0
Susan.Nicolson@thewomens.org.au
Contact person for public queries
Name 79027 0
Sarah-Pia Carron
Address 79027 0
Centre for Women's Mental Health, The Royal Women's Hospital, Cnr Grattan St & Flemington Rd, Parkville VIC 3052
Country 79027 0
Australia
Phone 79027 0
+61 3 8345 2793
Fax 79027 0
Email 79027 0
sarahpia.carron@thewomens.org.au
Contact person for scientific queries
Name 79028 0
Sarah-Pia Carron
Address 79028 0
Centre for Women's Mental Health, The Royal Women's Hospital, Cnr Grattan St & Flemington Rd, Parkville VIC 3052
Country 79028 0
Australia
Phone 79028 0
+61 3 8345 2793
Fax 79028 0
Email 79028 0
sarahpia.carron@thewomens.org.au

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

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

Documents added automatically
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