Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000194864
Ethics application status
Approved
Date submitted
7/02/2012
Date registered
15/02/2012
Date last updated
25/08/2024
Date data sharing statement initially provided
25/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial (RCT) of enhanced parenting to improve developmental outcomes in preterm infants.
Scientific title
An RCT to determine whether Prem Baby Triple P compared to routine care optimises child outcomes including behavioural and emotional adjustment, cognitive and language development at 2 years corrected age in infants born very preterm.
Secondary ID [1] 279859 0
NHMRC ID: 401647
Universal Trial Number (UTN)
Trial acronym
Prem Baby Triple P
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 285781 0
Condition category
Condition code
Public Health 285932 285932 0 0
Health promotion/education
Reproductive Health and Childbirth 286007 286007 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four modules will be delivered as 2 hour group sessions, one a week over four weeks, in the NICU by psychology graduates that have completed Triple P facilitator training. Session 1 includes explaining positive parenting, understanding a baby's behaviour and development, goal setting, and developing a positive relationship with your baby. Session 2 includes strategies for teaching new skills and behaviour, responding to your baby and managing crying and sleeping. Session 3 includes parenting traps, unpleasant emotions and how these affect parenting, coping strategies, and changes a baby brings to your life. Session 4 discusses partner support, including partner traps, communication, changes to your relationship, planning partner activities and dividing chores. A parent workbook accompanies the program and is given to parents for use with exercises and as a reference. Between sessions, parents complete homework tasks to consolidate learning. After hospital discharge, 4x30-min telephone consultations are conducted at 2, 3, 4 and 6 weeks corrected age (ca) with the family in their community by the trained Triple P facilitator who conducted the initial NICU-based sessions. The telephone sessions provide additional support to parents as they put into practice what has been learnt and the facilitator will assist parents in setting and reviewing parenting goals. This is followed by a facilitated transition to community based Triple P services with interventions continuing until the infants are 2 years of age using the established Triple P providers and with parents able to access all Triple P services available in their community including seminars, groups and enhanced individual support if required. Triple P has a range of community programs which include tailored variants and flexible delivery modes, to target different groups of high risk or vulnerable parents. The programs have a variety of outcomes including improved parent-child relationships, reduced child behaviour problems, reduced depression, stress and anxiety, decreased dysfunctional parenting and personal distress, and increased levels of self-efficacy, work commitment and work satisfaction. Prem Baby Triple P features different content to the community Triple P as it focuses on babies, particularly those born premature. The community component will be linked seamlessly to the neonatal component. Families transferred early to regional hospitals will be able to complete all modules of the neonatal aspect of the program through watching a DVD at home with follow-up telephone consultations with providers at Royal Brisbane & Women's Hospital and Mater Mothers' Hospital. Intervention group participants will also receive Triple P tip-sheets every 3 months up until 24 months corrected age and fortnightly text messages reiterating program content.
Intervention code [1] 284179 0
Treatment: Other
Intervention code [2] 284221 0
Lifestyle
Intervention code [3] 284222 0
Behaviour
Comparator / control treatment
Infants randomly assigned to the ‘Care as usual’ control group will receive standard follow-up after discharge which does not involve a structured preterm parenting program. It does include the standard medical and nursing care, resusitation instruction and discharge information that all families routinely receive. Exposure to any structured parenting programs will be measured at 2 years by parental recall. Prem Baby Triple P is not available outside this RCT. Baby Triple P is not yet available in the community.
Control group
Active

Outcomes
Primary outcome [1] 286418 0
A clinically important difference in child behavioural and emotional problems to be a standardised effect size of 0.33 on the ITSEA (A 92-item parent-report questionnaire to assess social-emotional problems/competencies in domains: behavioural dysregulation; externalising behaviour; internalising behaviour).
Timepoint [1] 286418 0
12 months ca, 24 months ca
Primary outcome [2] 286429 0
A 15-minute observation of mother-child interaction will be recorded and coded for child behavioural and emotional problems using the Family Observation Schedule Revised (FOS).
Timepoint [2] 286429 0
6 weeks ca, 12 months ca, 24 months ca
Secondary outcome [1] 295866 0
Child cognitive and language development will be assessed using the Bayley III.
Timepoint [1] 295866 0
24 months ca
Secondary outcome [2] 295868 0
The mother-child relationship will be assessed using the Maternal Infant Responsiveness Instrument (MIRI): a 22-item self-report questionnaire measuring maternal responsiveness to infant cues
Timepoint [2] 295868 0
6 weeks ca, 12 months ca
Secondary outcome [3] 295869 0
The mother-child relationship will be assessed using the Maternal Postnatal Attachment Scale (MPAS): A 19-item self-report questionnaire measuring a mother's emotional response to her infant.
Timepoint [3] 295869 0
6 weeks ca, 12 months ca
Secondary outcome [4] 295870 0
The mother-child relationship will be assessed using the Emotional Availability Scales (EAS): 15 minute mother-child interaction observation.
Timepoint [4] 295870 0
6 weeks ca, 12 months ca
Secondary outcome [5] 295871 0
Parenting style will be assessed using the Parenting Scale (PS): A 30-item measure of 3 dysfunctional parenting styles in parents.
Timepoint [5] 295871 0
24 months ca
Secondary outcome [6] 295872 0
Parenting style will be assessed using the Parenting Scale: A 30-item measure adapted from the original scale for parents of children 12 to 18 months.
Timepoint [6] 295872 0
12 months ca
Secondary outcome [7] 295873 0
Parenting self-efficacy will be assessed using the Maternal Self-Efficacy Scale (MSES; ): 10-item measure of parental self-efficacy.
Timepoint [7] 295873 0
6 weeks ca, 12 months ca, 24 months ca
Secondary outcome [8] 295874 0
Parental potential for child abuse will be assessed using the Brief Child Abuse Potential Inventory (BCAP): 33-item measure of the potential for child abuse.
Timepoint [8] 295874 0
24 months ca
Secondary outcome [9] 295876 0
Parental affective state will be assessed using the Edinburgh Postnatal Depression Scale (EDPS): A 10-item screen for postpartum depression.
Timepoint [9] 295876 0
baseline, 6 weeks ca, 12 months ca
Secondary outcome [10] 295877 0
Parental affective state will be assessed using the Depression, Anxiety and Stress Scale-21 (DASS -21): A 21 self-report item questionnaire reflecting the frequency or severity of the participant's experiences with depression, anxiety and stress over the past week.
Timepoint [10] 295877 0
24 months ca
Secondary outcome [11] 295878 0
Parental anxiety about their infant's health will be assessed using the Preterm Infant Parent Worry Index (PIPWI) : 7-item measure of the parent's anxiety about their preterm infant's health.
Timepoint [11] 295878 0
baseline, 6 weeks ca, 12 months ca
Secondary outcome [12] 295879 0
Parental stress associated with the preterm birth will be assessed using the Impact of Event Scale (IES): A 15-item self-report questionnaire measuring current subjective stress related to a specific event
Timepoint [12] 295879 0
baseline, 6 weeks ca, 12 months ca
Secondary outcome [13] 295880 0
Couple outcomes will be ssessed using the Relationship Quality Index (RQI): 6-item questionnaire of global relationship satisfaction.
Timepoint [13] 295880 0
Baseline, 6 weeks ca, 12 months ca, 24 months ca.
Secondary outcome [14] 295881 0
Couple outcomes will be ssessed using the Frequency and Acceptability of Partner Behaviour (FAPBI): 19-item measure of the frequency and acceptability of both positive and negative partner behaviours.
Timepoint [14] 295881 0
baseline, 6 weeks ca, 12 months ca,
Secondary outcome [15] 295882 0
Couple outcomes will be ssessed using the KPI coding system to code a 10-min observation of couple interaction, discussing a topic of current conflict. Couple communication is scored in 30 s intervals for conflict, invalidation and negative nonverbal affect.
Timepoint [15] 295882 0
Baseline, 6 weeks ca, 12 months ca, 24 months ca
Secondary outcome [16] 296390 0
Client satisfaction with the intervention will be assessed using the Client Satisfaction Questionnaire (CSQ): 10-item measure of the parent's satisfaction with the parent training program.
Timepoint [16] 296390 0
6 weeks ca, 12 weeks ca, 24 months ca
Secondary outcome [17] 305849 0
14-item Baby Behaviour Inventory (BBI) will be used to measure the baby's behaviour
Timepoint [17] 305849 0
6 weeks ca, 12 months ca
Secondary outcome [18] 310117 0
Language at 24 months ca will be assessed by CSBS DP Infant-Toddler Checklist (ITC): A parent report measure consisting of 24-items assessing early social communication behaviour.
Timepoint [18] 310117 0
24 months ca
Secondary outcome [19] 310118 0
The couple relationship will be assessed by the Parental Team subscale of the Parenting and Family Adjustment Scale (PAFAS). A self-report measure, the subscale consists of three items measuring the quality of the parent relationship.
Timepoint [19] 310118 0
24 months ca

Eligibility
Key inclusion criteria
Preterm infant born <32 weeks Parents must agree to assessment requirements of the study Parents must be english speaking
Minimum age
No limit
Maximum age
32 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infants: Born > 32 weeks, major congenital abnormalities Parents: No English spoken, do not agree to the assessment requirements of the study

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)
Allocation was concealed as the research nurse who determined if the subject was eligible for inclusion in the trial was unaware, when this decision was made, as to which group the subject would be allocated to. Group allocation was contained in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Infants will be assessed for eligibility and their parents approached as soon as their infant is clinically stable. Stratification will be for risk of brain injury on routine cranial ultrasound into (i) normal (NAD) or IVH grade 1 or IVH grade 2 (ii) IVH grade 3 or IVH grade 4 or PVL. Once the participants have been stratified, they complete baseline measures, then are randomised into the control or intervention group. Multiple births will be assigned to the same group.Randomisation will occur using a computer generated sequence that has been created off-site. A research student not associated with this study will create and seal the opaque randomisation envelopes. These envelopes will be opened in front of the participant after randomisation by the research nurse who is blind to the group allocation concealed in the envelope.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/03/2012
Actual
8/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
330
Accrual to date
323
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1787 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 1788 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 4939 0
4029
Recruitment postcode(s) [2] 7605 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 284636 0
Government body
Name [1] 284636 0
National Health and Medical Research Council
Country [1] 284636 0
Australia
Funding source category [2] 284637 0
Hospital
Name [2] 284637 0
Royal Children's Hospital
Country [2] 284637 0
Australia
Primary sponsor type
Individual
Name
Prof Paul Colditz
Address
University of Queensland Centre for Clinical Research.
Royal Brisbane & Women's Hospital Campus
Herston
QUEENSLAND 4029
Country
Australia
Secondary sponsor category [1] 283572 0
Individual
Name [1] 283572 0
Prof Matthew Sanders
Address [1] 283572 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
Brisbane
QUEENSLAND 4072
Country [1] 283572 0
Australia
Other collaborator category [1] 260498 0
Individual
Name [1] 260498 0
Prof Roslyn Boyd
Address [1] 260498 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Royal Children's Hospital
Herston Road
Herston
QUEENSLAND 4029
Country [1] 260498 0
Australia
Other collaborator category [2] 260499 0
Individual
Name [2] 260499 0
Dr Margo Pritchard
Address [2] 260499 0
Perinatal Research Centre
Royal Brisbane and Women's Hospital
Herston
QUEENSLAND 4029
Country [2] 260499 0
Australia
Other collaborator category [3] 260500 0
Individual
Name [3] 260500 0
A/Prof Peter Gray
Address [3] 260500 0
Mater Mother's Hospital
Raymond Terrace
South Brisbane
QUEENSLAND 4101
Country [3] 260500 0
Australia
Other collaborator category [4] 260501 0
Individual
Name [4] 260501 0
A/Prof Michael O'Callaghan
Address [4] 260501 0
Mater Children's Hospital
Raymond Terrace
South Brisbane
QUEENSLAND 4101
Country [4] 260501 0
Australia
Other collaborator category [5] 260502 0
Individual
Name [5] 260502 0
Prof Virginia Slaughter
Address [5] 260502 0
School of Psychology
The University of Queensland
Brisbane
QUEENSLAND 4072
Country [5] 260502 0
Australia
Other collaborator category [6] 260503 0
Individual
Name [6] 260503 0
Dr Koa Whittingham
Address [6] 260503 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Royal Children's Hospital
Herston Road
Herston
QUEENSLAND 4029
Country [6] 260503 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286629 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 286629 0
Ethics committee country [1] 286629 0
Australia
Date submitted for ethics approval [1] 286629 0
18/09/2008
Approval date [1] 286629 0
14/09/2009
Ethics approval number [1] 286629 0
HREC/08/QRBW/33
Ethics committee name [2] 286630 0
Royal Children's Hospital
Ethics committee address [2] 286630 0
Ethics committee country [2] 286630 0
Australia
Date submitted for ethics approval [2] 286630 0
17/11/2008
Approval date [2] 286630 0
22/01/2009
Ethics approval number [2] 286630 0
HREC/08/QRCH/114
Ethics committee name [3] 286631 0
University of Queensland
Ethics committee address [3] 286631 0
Ethics committee country [3] 286631 0
Australia
Date submitted for ethics approval [3] 286631 0
12/12/2008
Approval date [3] 286631 0
13/07/2011
Ethics approval number [3] 286631 0
2008002268
Ethics committee name [4] 286632 0
Mater Mother's Hospital
Ethics committee address [4] 286632 0
Ethics committee country [4] 286632 0
Australia
Date submitted for ethics approval [4] 286632 0
15/09/2009
Approval date [4] 286632 0
24/09/2009
Ethics approval number [4] 286632 0
1419M

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

Contacts
Principal investigator
Name 33724 0
Prof Paul Colditz
Address 33724 0
University of Queensland Centre for Clinical Research Building 71/918 Royal Brisbane & Women's Hospital Campus Herston QUEENSLAND 4029
Country 33724 0
Australia
Phone 33724 0
+ 61 7 3346 5555
Fax 33724 0
Email 33724 0
[email protected]
Contact person for public queries
Name 16971 0
Prof Paul Colditz
Address 16971 0
University of Queensland Centre for Clinical Research
Building 71/918
Royal Brisbane & Women's Hospital Campus
Herston
QUEENSLAND 4029
Country 16971 0
Australia
Phone 16971 0
+ 61 7 3346 5555
Fax 16971 0
+ 61 7 3346 5509
Email 16971 0
[email protected]
Contact person for scientific queries
Name 7899 0
Prof Paul Colditz
Address 7899 0
University of Queensland Centre for Clinical Research
Building 71/918
Royal Brisbane & Women's Hospital Campus
Herston
QUEENSLAND 4029
Country 7899 0
Australia
Phone 7899 0
+ 61 7 3346 5555
Fax 7899 0
+ 61 7 3346 5509
Email 7899 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
UQ Guidelines on Research Data Sharing: Research data with Mediated Access requires the researcher to approve access to the data first before use by another researcher. It allows the data to be accessed and used correctly, and in accordance with ethics requirements or other contextual conditions. Visit Request access to data for advice on agreements for sharing and accessing research data.


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
SourceTitleYear of PublicationDOI
EmbasePrem Baby Triple P: A randomised controlled trial of enhanced parenting capacity to improve developmental outcomes in preterm infants.2015https://dx.doi.org/10.1186/s12887-015-0331-x
EmbaseA Randomized Trial of Baby Triple P for Preterm Infants: Child Outcomes at 2 Years of Corrected Age.2019https://dx.doi.org/10.1016/j.jpeds.2019.01.024
EmbasePredictors of Maternal Bonding and Responsiveness for Mothers of Very Preterm Infants.2022https://dx.doi.org/10.1007/s10880-021-09833-w
N.B. These documents automatically identified may not have been verified by the study sponsor.