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Trial registered on ANZCTR


Registration number
ACTRN12613000948796
Ethics application status
Approved
Date submitted
22/08/2013
Date registered
27/08/2013
Date last updated
31/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of Baby Triple P: An evaluation of an antenatal parenting program to improve parental responsiveness in first-time parents
Scientific title
A randomised controlled trial of Baby Triple P: An evaluation of an antenatal parenting program to improve parental responsiveness in first-time parents
Secondary ID [1] 283007 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preventative parenting 289834 0
Condition category
Condition code
Mental Health 290190 290190 0 0
Studies of normal psychology, cognitive function and behaviour
Reproductive Health and Childbirth 290289 290289 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baby Triple P: This is a preventative intervention for first time parents. It involves four weekly 2-hour group sessions during the antenatal period which cover parenting topics, the couple relationship and individual adjustment of the parents. There are also four weekly 20-minute telephone consultations in the postnatal period starting when the baby is 6 weeks old which reinforce the strategies learned during the group sessions. Telephone consultations will be conducted primarily with the mother, however it would be encouraged if the father is present as well. The intervention group will further receive a workbook at the start of the program (at the first session during pregnancy) which will be used throughout the program and can be used at home. Parenting topics to be covered are: teaching couples parenting strategies (Sessions 1 & 2), individual coping skills (Session 3) and partner support skills (Session 4). The parenting strategies are designed to promote a warm and responsive relationship between parents and their babies as well as promoting a positive learning environment for the infant. The 4 telephone consultations will not cover any new material, rather it provides the opportunity to problem solve and it employs a self-regulatory model. Adherence to the intervention will be monitored by marking attendance of both parents at the sessions.
Intervention code [1] 287719 0
Prevention
Intervention code [2] 287799 0
Behaviour
Comparator / control treatment
The control group consists of a care-as usual group. This group will receive care as they normally would in the community (e.g. by their GP, obstetrician or other health services). At completion of the study, this group will receive a short seminar of the Baby Triple P content and the workbook to work through the topics on their own.
Control group
Active

Outcomes
Primary outcome [1] 290218 0
Maternal Confidence as assessed by the Maternal Self-report Inventory
Timepoint [1] 290218 0
When the baby is 10 weeks old and when the baby is 6 months old.
Primary outcome [2] 296662 0
Maternal sense of competence as assessed by the Maternal Self Efficacy Questionnaire
Timepoint [2] 296662 0
Baseline, when baby is 10 weeks and when baby is 6 months old.
Secondary outcome [1] 304131 0
parental depression as assessed by the Edinburgh Postnatal Depression Inventory
Timepoint [1] 304131 0
Baseline, when baby is 10 weeks and again when baby is 6 months old
Secondary outcome [2] 304132 0
Parental anxiety as assessed by the Depression, Anxiety and Stress (21) inventory.
Timepoint [2] 304132 0
Baseline, when baby is 10 weeks and when baby is 6 months old
Secondary outcome [3] 304133 0
Pregnancy worry assessed by the Cambridge Worry Scale
Timepoint [3] 304133 0
Baseline, when baby is 10 weeks and 6 months old
Secondary outcome [4] 304134 0
Life satisfaction / happiness by parents as assessed by the Oxford Happiness Questionnaire
Timepoint [4] 304134 0
Baseline, when baby is 10 weeks and 6 months old.
Secondary outcome [5] 304135 0
Maternal Responsiveness measured by the Maternal Infant Responsiveness Inventory and an observational measure using the Care Index
Timepoint [5] 304135 0
when baby is 10 weeks and 6 months old.
Secondary outcome [6] 304137 0
Mother-child bonding as assessed by the Postpartum Bonding Instrument
Timepoint [6] 304137 0
when baby is 10 weeks and 6 months old.
Secondary outcome [7] 304138 0
Improved baby behaviours including reduced crying and fussing and fewer sleeping and feeding problems assessed using a Baby Diary which asks parents to record the behaviours over a 24hour period, and also using the Baby Behaviour Inventory, which measures the extent of a range of behaviours that parents often find challenging during the first twelve months
Timepoint [7] 304138 0
when baby is 10 weeks and 6 months old.
Secondary outcome [8] 304139 0
Improved Couple relationship assessed by three items from the Parenting and Family Adjustment Scale, 2 items from the Household and Childcare Task Checklist and 1 item on overall relationship satisfaction
Timepoint [8] 304139 0
Baseline, when baby is 10 weeks old and 6 months old

Eligibility
Key inclusion criteria
Interested couples have to meet the following inclusion criteria: (a) experiencing a first pregnancy (between 20 and 35 weeks gestation), (b) absence of an intellectual disability or severe psychopathology which would impair participant’s understanding of the material presented in the program, (c) basic level of literacy, (d) absence of a diagnosed genetic disorder or disability in the baby. Couples will also have to meet at least 2 of the following risk factors:
a) unplanned pregnancy
b) low education
c) low income or experience financial strain
d) low relationship satisfaction
e) low social support
f) history of maternal/ paternal depression or anxiety
g) current depression
h) current anxiety
i) low confidence in ability to parent
j) low life satisfaction/ happiness
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. The parents have a disability, pre­diagnosed medical condition or severe psychopathology which would impair participant’s understanding of the material presented in the program.
2. The parents are currently receiving psychological help or counselling
3. Major complications during pregnancy or disability in the baby
4. The couple expects to move away from the Brisbane region before completion of the program

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)
After meeting eligibility criteria, participants will be randomised to either the treatment or the care as usual group by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using www.randomizer.org was used. Uneven numbers indicate allocation to treatment condition, even numbers to the care as usual condition. An assistant not involved placed group allocation numbers in sealed envelopes to ensure concealed allocation to groups by the project investigator.
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
A power analysis was conducted via Optimal Design software to determine the required sample size for the planned multilevel modeling of longitudinal data. To detect a medium effects size of .50, with alpha set at .05, and power at .80, a minimum sample size of 80 participants per group is needed (i.e., N = 160 for the two-group study). Allowing for potential attraction of 25% the proposed sample size will provide sufficient power to conduct the proposed analyses.

To test change over time due to the intervention we will apply Multilevel Modelling and more precisely we will test Multilevel Latent Growth Curve Models (MLMLGCM) in MPlus version 7.12. The MLM modeling will enable us to test the effects of the intervention across three time points and between two conditions (intervention vs. care as usual). The primary advantage of using Multilevel Modelling approach to longitudinal repeated-measures data is allows for appropriate treatment of missing data points by applying Full Information Maximum Likelihood approach. This maximizes power to detect effects and reduces bias owing to missing data in longitudinal studies

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1430 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 1431 0
Ipswich Hospital - Ipswich
Recruitment hospital [3] 1432 0
Redland Hospital - Cleveland
Recruitment hospital [4] 1433 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [5] 1434 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [6] 1435 0
North Lakes Day Hospital - North Lakes

Funding & Sponsors
Funding source category [1] 287772 0
University
Name [1] 287772 0
This project does not currently have external funding for support. Necessary expenses will be covered by the School of Psychology and the Parenting and Family Support Centre at the University of Queensland.
Address [1] 287772 0
School of Psychology, University of Queensland, St Lucia 4072 QLD
Country [1] 287772 0
Australia
Primary sponsor type
Individual
Name
Mandy Mihelic
Address
School of Psychology, University of Queensland, St Lucia 4072 QLD
Country
Australia
Secondary sponsor category [1] 286499 0
Individual
Name [1] 286499 0
Dr Alina Morawsksa
Address [1] 286499 0
Parenting and Family Support Centre, School of Psychology, University of Queensland, St Lucia 4072 QLD
Country [1] 286499 0
Australia
Secondary sponsor category [2] 289855 0
Individual
Name [2] 289855 0
Dr Ania Filus
Address [2] 289855 0
Center for Social & Economic Research
University of Southern California
635 Downey Way
Los Angeles, Ca 90089-3332
Country [2] 289855 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289721 0
Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 289721 0
The University of Queensland Cumbrae-Stewart Building Research Road
Brisbane Qld 4072 Australia
Ethics committee country [1] 289721 0
Date submitted for ethics approval [1] 289721 0
Approval date [1] 289721 0
06/05/2013
Ethics approval number [1] 289721 0
2013000564
Ethics committee name [2] 289722 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [2] 289722 0
Royal Brisbane & Women's Hospital, Level 7 Block 7, Butterfield Street, Herston QLD 4029
Ethics committee country [2] 289722 0
Australia
Date submitted for ethics approval [2] 289722 0
Approval date [2] 289722 0
05/08/2013
Ethics approval number [2] 289722 0
HREC/13/QRBW/177

Summary
Brief summary
The transition to parenthood is a very exciting time for new parents, but it also is a time of great demands and challenges. After the baby is born, parents are faced with sleep deprivation, mastering infant caregiving tasks, changes in their relationships and lifestyle. At the same time, these early months are crucial for the infant's development and wellbeing.
The proposed project aims to evaluate Baby Triple P, a preventative intervention designed to support parents during the transition to first­time parenthood. It aims to give babies a healthy start in life by enhancing their parent’s knowledge, skills and confidence in early parenting practices. In addition, it intends to protect the mental and emotional wellbeing of parents.
The transition to parenthood can be particularly challenging for families where a range of risk factors are present, and it is couples who are at risk for experiencing difficulties at the transition that may benefit most from a preventative intervention. Specifically, this project focuses on couples who experience at least two of the following risk factors: unplanned pregnancy, low education, experience financial strain, low relationship satisfaction, low social support, history of and/or current depression or anxiety, low confidence in ability to parent or low life satisfaction. This was done as these couples may benefit the most from Baby Triple P.
Participants will be approximately 150 couples where the mother is 20­-35 weeks pregnant. Recruitment will be done through primary care settings, GPs, hospitals in the Brisbane and Ipswich area and targeted mail­out and media campaigns.
The research will be carried out as a randomised controlled trial comparing the Baby Triple P group to a care as usual group. The study is a 2 (Baby Triple P vs care as usual) x 3 (time­points: pre­test, post­test, 6­month follow up) design. The intervention consists of four weekly 2­hour group sessions during pregnancy, and four weekly 20­ minute telephone consultations starting when the baby is about 6 weeks old.
Assessment will include a series of self­report questionnaires (pre­, post­, and follow­up) and a home observation, which will observe mothers as they normally interact with the baby (post­ and follow­up).
The primary outcome variable for this study is parental confidence/ self-efficacy. Accordingly, it is hypothesised that compared to the care as usual group:
H1: Participation in Baby Triple P will lead higher levels of parenting confidence and perceived competence.
This study will also look at several secondary outcome variables. For these,it is hypothesised that, compared with the care as usual control group, participation in Baby Triple P will lead to:
H2: higher levels of parental responsiveness and bonding to the baby.,
H3: higher relationship happiness,
H4: higher levels of life satisfaction
H5: fewer instances of depression or anxiety
H6: Infants will show less fussing, crying and fewer sleeping p
Trial website
https://exp.psy.uq.edu.au/baby/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42114 0
Miss Mandy Mihelic
Address 42114 0
Parenting and Family Support Centre, School of Psychology, University of Queensland, St Lucia 4072 QLD
Country 42114 0
Australia
Phone 42114 0
+61 7 3365 8870
Fax 42114 0
Email 42114 0
mandy.mihelic@uq.net.au
Contact person for public queries
Name 42115 0
Miss Mandy Mihelic
Address 42115 0
Parenting and Family Support Centre, School of Psychology, University of Queensland, St Lucia 4072 QLD
Country 42115 0
Australia
Phone 42115 0
+61 7 3365 8870
Fax 42115 0
Email 42115 0
mandy.mihelic@uq.net.au
Contact person for scientific queries
Name 42116 0
Miss Mandy Mihelic
Address 42116 0
Parenting and Family Support Centre, School of Psychology, University of Queensland, St Lucia 4072 QLD
Country 42116 0
Australia
Phone 42116 0
+61 7 3365 8870
Fax 42116 0
Email 42116 0
mandy.mihelic@uq.net.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary