Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000073808
Ethics application status
Approved
Date submitted
1/12/2020
Date registered
29/01/2021
Date last updated
6/12/2022
Date data sharing statement initially provided
29/01/2021
Date results information initially provided
6/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing parenting skills for women at risk of perinatal depression in a low-resource setting: a randomised controlled trial of Triple P for Baby
Scientific title
A randomised controlled trial of the effect of a positive parenting Program (Triple P for Baby) on maternal depressive symptoms in pregnant women in a low-resource setting
Secondary ID [1] 302907 0
None
Universal Trial Number (UTN)
Trial acronym
TPB (Triple P for Baby)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal depression 319921 0
Condition category
Condition code
Mental Health 317861 317861 0 0
Depression
Reproductive Health and Childbirth 318159 318159 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants will participate in four, 2-hour weekly group sessions of Triple P for Baby (parenting intervention) in the third trimester of pregnancy, followed by four, 30-minute weekly individual telephone sessions delivered postnatally. In total, the intervention will be conducted in eight sessions. Triple P for Baby includes strategies for developing a positive relationship with the baby, teaching the baby new skills and behaviours, responding to the baby, dealing with baby’s crying, promoting positive sleep habits, dealing with unpleasant emotions, enhancing partner communication, maintaining relationship happiness, and sharing tasks.
The program will be delivered by the principal investigator who is an accredited Triple P practitioner/psychologist, and the group sessions will be conducted within the antenatal care clinics at the Moi Teaching and Referral Hospital in Eldoret, Kenya. During the sessions, participants will engage interactively through discussions, group tasks, and role-plays. Participants will be assigned tasks to complete during the session and in-between sessions. Participants will be issued with the Triple P for Baby workbook (Spry, Morawska & Sanders, 2011) describing the session content and homework tasks-including filling in a behaviour monitoring chart and baby diary, which takes about 30 minutes for each day of the 7-day period. The facilitator will use a manual and session checklist to enhance strict adherence to the intervention protocol, and where possible an audio recording of the session will be done for assessment of fidelity. The facilitator manuals have been developed by Triple P International Pty Ltd, Australia and are readily available for purchase and use. The interventionist will receive regular clinical supervision from an accredited Triple P for Baby expert to ensure fidelity in content and program delivery.
Intervention code [1] 319196 0
Behaviour
Comparator / control treatment
Participants in the comparison group will continue to receive standard antenatal care as usual (CAU) services as per the Kenyan ministry of health guidelines captured in the mother-baby booklet (issued to all pregnant women) for the entire duration of the study. The mother-baby booklets are a free resource and are usually supplied to all public hospitals in Kenya by the ministry of health. Every pregnant mother receives a copy of the booklet upon registering in the ANC clinic. The booklets are readily available. Participants in the CAU group will have no contact with mothers attending Triple P for Baby and contact between the research team and CAU participants will be restricted to assessments.
Control group
Active

Outcomes
Primary outcome [1] 325883 0
Change in maternal depressive symptoms assessed using The Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)
Timepoint [1] 325883 0
Baseline (T1/before randomisation), Post-intervention (T2/10 weeks postpartum) and Follow-up (T3/6 months postpartum).
Primary outcome [2] 333301 0
Change in maternal anxiety symptoms assessed using The Generalised Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)
Timepoint [2] 333301 0
T1/Baseline (1-week pre-randomisation), T2/Post-intervention (10 weeks post-birth) and T3/Follow-up (6 months post-birth).
Secondary outcome [1] 389418 0
Change in maternal confidence assessed using the Maternal Self-Efficacy Scale (MSES; Teti & Gelfand, 1991)
Timepoint [1] 389418 0
T2/Post-intervention and T3/Follow-up (6 months postpartum)
Secondary outcome [2] 389420 0
Change in maternal responsiveness assessed using the Maternal Infant Responsiveness Instrument (MIRI; Amankwaa & Pickler, 2007)
Timepoint [2] 389420 0
T2/Post-intervention and T3/Follow-up (6 months postpartum)
Secondary outcome [3] 390243 0
Changes in infant behaviour assessed using the Baby Behaviour Inventory (BBI; Spry, Morawska, & Sanders, 2007a)
Timepoint [3] 390243 0
12 weeks, 16 weeks, 20 weeks, and 24 weeks (postpartum)
Secondary outcome [4] 391105 0
Infant developmental outcomes as assessed using the Parent’s Evaluation of Developmental Status: Developmental Milestones (PEDS: DM; Brothers, Glascoe, & Robertshaw, 2008). The assessment measures capture multiple aspects of infant developmental domains including language, socio-emotional and motor skills. All three developmental domains will be analysed together as a composite outcome.
Timepoint [4] 391105 0
Follow-up (T3/6 months postpartum)

Eligibility
Key inclusion criteria
Participants will be included in the study if they meet the following eligibility criteria: (a) 26 to 32 weeks pregnant, (b) possess high school or equivalent English language competency, (c) at least 18 years of age, (d) living within a radius of 45 minutes’ drive for ease of travel and reach, and (e) screens positive for depressive symptoms.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if: a) they cannot read and write English, (b) have a medically reported high-risk pregnancy, (c) are experiencing severe episodes of any form of psychopathology, (d) are currently receiving antidepressant therapy, or (e) currently receiving psychological or counselling services.

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)
Random allocation numbers will be generated by a researcher who is external to the study in sealed opaque envelopes and eligible participants will only be informed of their assigned groups after baseline measures have been administered.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sampling: A previous meta-analysis on psychological interventions for postnatal depression found an estimated effect size of 0.38 (Cohen’s d). In this study, to detect an effect of Cohen’s d = 0.38 (small effect), for rANOVA, looking at the within-between interactions, based on maternal depressive symptoms as the primary outcome measure, at a significance level of .05 (two-tailed) and power set to .80 with a correlation among repeated measures set to 0.1, a sample size of 82 participants is required. The sample was determined using G*Power software version 3.1.

Analysis: Both descriptive and inferential statistics will be used in data analyses and presentation. Prior to the main analysis, data cleaning, coding and preliminary analysis of assumptions of normality will be conducted. Overall, intent-to-treat principles will be followed in the analysis. Means and variance of study outcomes for each group from T1 to T3 will be presented using descriptive statistics. Logistic regression models will be used to examine missing data and multiple imputations of missing data will be done using the Markov Chain Monte Carlo method where possible. The post-intervention data will be used to inform multiple imputations of missing data for the outcome variables at six months follow-up (postpartum) and to examine the difference in changes of the outcome variable between the study arms. Group baseline demographic and clinical characteristics will be reported and presented in tables; between and within-group comparisons across longitudinal assessment points will be done using mixed between-within ANOVA. Generalised estimating equations (GEE) will be used to model the effect of the intervention on maternal depression across time (interaction effect) if Gaussian distribution assumptions are violated. Where possible multilevel modelling will be used to handle clustered/grouped data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2021
Actual
29/03/2021
Date of last participant enrolment
Anticipated
30/06/2021
Actual
27/08/2021
Date of last data collection
Anticipated
28/03/2022
Actual
27/05/2022
Sample size
Target
94
Accrual to date
Final
82
Recruitment outside Australia
Country [1] 23238 0
Kenya
State/province [1] 23238 0
Uasin Gishu

Funding & Sponsors
Funding source category [1] 307328 0
University
Name [1] 307328 0
The University of Queensland
Country [1] 307328 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 307967 0
None
Name [1] 307967 0
Address [1] 307967 0
Country [1] 307967 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307417 0
University of Queensland Research Ethics Committee
Ethics committee address [1] 307417 0
Research Ethics and Integrity,

The University of Queensland
Brisbane QLD 4072
Ethics committee country [1] 307417 0
Australia
Date submitted for ethics approval [1] 307417 0
Approval date [1] 307417 0
27/11/2020
Ethics approval number [1] 307417 0
2020002769
Ethics committee name [2] 312093 0
MTRH/MU-Institutional Research and Ethics Committee (IREC)
Ethics committee address [2] 312093 0
Moi Teaching and Referral Hospital/Moi University,
MTRH Building, Nandi Road, Eldoret, Uasin Gishu, Kenya
P.O. Box 3
Eldoret 30100
Kenya-East Africa
Ethics committee country [2] 312093 0
Kenya
Date submitted for ethics approval [2] 312093 0
05/01/2021
Approval date [2] 312093 0
25/03/2021
Ethics approval number [2] 312093 0
0003837

Summary
Brief summary
The study aims to test the efficacy of a positive parenting program for perinatal depression and infant outcomes. Expectant mothers will participate in a randomised controlled trial. Mothers assigned to the intervention group will engage in 4x2-hour group sessions and 4x30-minute telephone sessions of Triple P for Baby in addition to the care as usual. Mothers assigned to the comparison group will continue with the care as usual for the study duration. In this study, we will collect information regarding participants' mental health, parenting competence, and infants' developmental outcomes at the set assessment points. Differences in depressive symptoms are expected, as well as differences in parenting competence and efficacy that should mediate the type of infant outcomes obtained. We will compare the results on all outcome measures across time and use the data to test the efficacy of the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107166 0
Mr Japheth Adina
Address 107166 0
13 Upland Rd, Parenting and Family Support Centre, School of Psychology, The University of Queensland, Brisbane QLD 4072
Country 107166 0
Australia
Phone 107166 0
+61 411149966
Fax 107166 0
Email 107166 0
j.adina@uqconnect.edu.au
Contact person for public queries
Name 107167 0
Mr Japheth Adina
Address 107167 0
13 Upland Rd, Parenting and Family Support Centre, School of Psychology, The University of Queensland, Brisbane QLD 4072
Country 107167 0
Australia
Phone 107167 0
+61 411149966
Fax 107167 0
Email 107167 0
j.adina@uqconnect.edu.au
Contact person for scientific queries
Name 107168 0
A/Prof Alina Morawska
Address 107168 0
13 Upland Rd, Parenting and Family Support Centre, School of Psychology, The University of Queensland, Brisbane QLD 4072
Country 107168 0
Australia
Phone 107168 0
+61 733657304
Fax 107168 0
Email 107168 0
alina@psy.uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results
When will data be available (start and end dates)?
Data will be available immediately following publication with no end date.
Available to whom?
Researchers will be able to access the data on a case-by-case basis at the discretion of the University of Queensland/Primary sponsor.
Available for what types of analyses?
Data will be available for any research purpose
How or where can data be obtained?
Data will be de-identified and stored in the University of Queensland Research Data Manager (UQRDM) with limited access (restricted to authorised individuals/researchers) through the link:
https://cloud.rdm.uq.edu.au/simplesaml/module.php/uqmultiauth/selectsource.php?

Alternatively, the data can be accessed by directly emailing the PI at j.adina@uqconnect.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9907Ethical approval    381027-(Uploaded-01-12-2020-14-10-35)-Study-related document.pdf



Results publications and other study-related documents

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