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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

preventative parenting

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Reproductive Health and Childbirth

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]

Prevention

Intervention code [2]

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]

Maternal Confidence as assessed by the Maternal Self-report Inventory

Timepoint [1]

When the baby is 10 weeks old and when the baby is 6 months old.

Primary outcome [2]

Maternal sense of competence as assessed by the Maternal Self Efficacy Questionnaire

Timepoint [2]

Baseline, when baby is 10 weeks and when baby is 6 months old.

Secondary outcome [1]

parental depression as assessed by the Edinburgh Postnatal Depression Inventory

Timepoint [1]

Baseline, when baby is 10 weeks and again when baby is 6 months old

Secondary outcome [2]

Parental anxiety as assessed by the Depression, Anxiety and Stress (21) inventory.

Timepoint [2]

Baseline, when baby is 10 weeks and when baby is 6 months old

Secondary outcome [3]

Pregnancy worry assessed by the Cambridge Worry Scale

Timepoint [3]

Baseline, when baby is 10 weeks and 6 months old

Secondary outcome [4]

Life satisfaction / happiness by parents as assessed by the Oxford Happiness Questionnaire

Timepoint [4]

Baseline, when baby is 10 weeks and 6 months old.

Secondary outcome [5]

Maternal Responsiveness measured by the Maternal Infant Responsiveness Inventory and an observational measure using the Care Index

Timepoint [5]

when baby is 10 weeks and 6 months old.

Secondary outcome [6]

Mother-child bonding as assessed by the Postpartum Bonding Instrument

Timepoint [6]

when baby is 10 weeks and 6 months old.

Secondary outcome [7]

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]

when baby is 10 weeks and 6 months old.

Secondary outcome [8]

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]

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

Sex

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

30/09/2013

Actual

19/10/2013

Date of last participant enrolment

Anticipated

31/03/2015

Actual

20/03/2015

Date of last data collection

Anticipated

Actual

29/01/2016

Sample size

Target

160

Accrual to date

Final

112

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [2]

Ipswich Hospital - Ipswich

Recruitment hospital [3]

Redland Hospital - Cleveland

Recruitment hospital [4]

Mater Mother's Hospital - South Brisbane

Recruitment hospital [5]

Redcliffe Hospital - Redcliffe

Recruitment hospital [6]

North Lakes Day Hospital - North Lakes

Funding & Sponsors

Funding source category [1]

University

Name [1]

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]

School of Psychology, University of Queensland, St Lucia 4072 QLD

Country [1]

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]

Individual

Name [1]

Dr Alina Morawsksa

Address [1]

Parenting and Family Support Centre, School of Psychology, University of Queensland, St Lucia 4072 QLD

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr Ania Filus

Address [2]

Center for Social & Economic Research
University of Southern California
635 Downey Way
Los Angeles, Ca 90089-3332

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Behavioural and Social Sciences Ethical Review Committee

Ethics committee address [1]

The University of Queensland Cumbrae-Stewart Building Research Road
Brisbane Qld 4072 Australia

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

06/05/2013

Ethics approval number [1]

2013000564

Ethics committee name [2]

Royal Brisbane & Women's Hospital Human Research Ethics Committee

Ethics committee address [2]

Royal Brisbane & Women's Hospital, Level 7 Block 7, Butterfield Street, Herston QLD 4029

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

05/08/2013

Ethics approval number [2]

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

Miss Mandy Mihelic

Address

Parenting and Family Support Centre, School of Psychology, University of Queensland, St Lucia 4072 QLD

Country

Australia

Phone

+61 7 3365 8870

Fax

mandy.mihelic@uq.net.au

Contact person for public queries

Name

Mandy Mihelic

Address

Parenting and Family Support Centre, School of Psychology, University of Queensland, St Lucia 4072 QLD

Country

Australia

Phone

+61 7 3365 8870

Fax

mandy.mihelic@uq.net.au

Contact person for scientific queries

Name

Mandy Mihelic

Address

Parenting and Family Support Centre, School of Psychology, University of Queensland, St Lucia 4072 QLD

Country

Australia

Phone

+61 7 3365 8870

Fax

mandy.mihelic@uq.net.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

Source	Title	Year of Publication	DOI
Embase	Preparing parents for parenthood: Protocol for a randomized controlled trial of a preventative parenting intervention for expectant parents.	2018	https://dx.doi.org/10.1186/s12884-018-1939-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

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