Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001282279
Ethics application status
Approved
Date submitted
23/07/2018
Date registered
30/07/2018
Date last updated
14/06/2022
Date data sharing statement initially provided
29/09/2020
Date results information initially provided
29/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Experiences of Parenting. Understanding parents' views on parenting and programs for parents
Scientific title
Understanding parental engagement in parenting interventions: A between-subjects experimental study of engagement strategies based on health-behaviour theories
Secondary ID [1] 295497 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low parental engagement in preventive interventions 308764 0
Condition category
Condition code
Mental Health 307696 307696 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 307697 307697 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current trial aims to test the effectiveness of engagement strategies based on the constructs of the Health Belief Model (HBM) and the Theory of Planned Behaviour (TPB) on the initial engagement (i.e. recruitment, enrolment, and first attendance) of parents of young children to parenting interventions. We will focus on the message communicated in the engagement strategy and the format used as a channel to communicate that message. The message will be communicated by a parent, involving about 100 words for the written format and at about 1 minute for the video format. Thus, this 2x2 double-blind trial will consist of two experimental studies, each one of which will test a theory; Experiment 1 focuses on HBM and Experiment 2 tests the TPB. Thus, the intervention arms for Experiment 1 are 1) benefits-video (ES1), 2) benefits-written (ES2), 3) costs-video (ES3), and 4) costs-written (ES4). The intervention arms for Experiment 2 are 1) subjective norms-video (ES5), 2) subjective norms-written (ES6), 3) attitudes-video (ES7), and 4) attitudes-written (ES8). Both experiments 2 will be conducted in sequence. Once Experiment 1 reaches the required sample size (Stage 1), Experiment 2 will be conducted (Stage 2). Thus, participants will take part in the Experiment running at the time of their participation in the study.
Eligible participants will be parents of children aged 2 to 12 years old in Australia. We aim to recruit 164 parents per experiment (total sample of 328 parents across experiments).
In terms of the procedure, parents will be recruited from different sources, such as childcare and schools, social media, and parent organisations. Parents will be invited to visit the research project website to share their views on parenting. Those parents who access the website will be directed to the information sheet, consent form, and some of the measures (demographics, past participation, child behaviour problems, parental self-efficacy, and parenting practices). Immediately after completing these measures, parents will be randomly exposed to one of the four conditions for that experiment (i.e., ES1-ES4 for Experiment 1, and ES5-ES8 for Experiment 2). Once parents are exposed to the corresponding condition, they will be asked to answer the manipulation check questions (i.e., questions regarding the source of information and format of the manipulation) and the two questionnaires based on the HBM (i.e. questions regarding benefits and barriers) and TPB (i.e., questions regarding subjective norms, attitudes, and perceived behavioural control). After they answer these questions, parents will complete initial parental engagement measures (i.e. recruitment, enrolment). If parents answer ‘Yes’ to the enrolment question, they will be asked to provide contact details (name and both telephone and email, indicating preferred contact method) to receive the particular parenting intervention (Self-Directed Positive Parenting Program-Triple P) by mail. The Self-Directed Triple P is an intervention that parents can complete at their own pace. It has shown to have comparable effectiveness to other delivery formats and receive positive feedback from parents. When parents select ‘Yes”, they will be directed to a new page where they will provide contact details. Within a month, parents will be asked regarding their progress in the self-directed workbook, which will indicate if they have completed the action considered as first attendance. Once participants complete this follow-up contact, their participation in the trial ends.
Intervention code [1] 301818 0
Prevention
Comparator / control treatment
For Experiment 1, the comparator will be the ES4 (cost-written) because it is the condition what would be expected to show lower initial parental engagement. In terms of Experiment 2, the comparator will be the ES8 as this condition is expected to have a lower impact on initial parental engagement.
Control group
Active

Outcomes
Primary outcome [1] 306685 0
Recruitment. For this outcome, parents will answer to the question ‘I intend to participate in this parenting program during the next six months’, scored on a 5-point Likert scale ranging from 1 ‘Definitely no’ to 5 ‘Definitely yes’, and including the middle option ‘Unsure’.
Timepoint [1] 306685 0
Immediately post-intervention
Primary outcome [2] 306881 0
Enrolment. Regarding this outcome, all parents will be asked ‘Would you like to enrol in this parenting program now?’ and the responses will include the options ‘Yes’ and ‘No’. Parents who complete this stage will be considered as enrolled (measure of enrolment).
Timepoint [2] 306881 0
Immediately post-intervention
Primary outcome [3] 306882 0
First attendance. To measure this outcome, there is an interview protocol (including questions such as ‘Have you reviewed the content from Week 1 in the workbook?’, and ‘What page in the workbook are you up to now?’) to ask parents questions to determine if they have completed (Yes/No) the first action required by the program.
Timepoint [3] 306882 0
Post-intervention (1-month follow-up)
Secondary outcome [1] 349415 0
N/A
Timepoint [1] 349415 0
N/A

Eligibility
Key inclusion criteria
Participants of this trial are parents only. Still, these parents will need to have a child aged between 2 and 12 years old to take part in this trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents will be excluded if they are not able to read in English-language without assistance (rationale: the written materials will be written in English, so they are not suitable for parents who are not confident with reading 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)
Parents will be randomly allocated to one of the four conditions of each experiment using a computer-generated list of random numbers in a 1:1 allocation ratio. Given the online feature of this study and the randomisation procedure, both participants and researchers will be blind to condition allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will involve computerised sequence generation following a 1:1 allocation ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be entered and prepared with IBM SPSS Version 24. Statistical analyses will be performed using SPSS (Allen, Bennett, & Heritage, 2014; Yockey, 2018). Descriptive statistics will be reported. Chi-square analyses (4-point Likert scales will be coded as a dichotomised variable) will be used to detect group differences between experimental groups and initial parental engagement measures (recruitment, enrolment, and first attendance). If significant differences are reported, post hoc analyses will be conducted to identify further difference patterns. Thus, post hoc analyses will include the calculations of adjusted z values and adjusted p-value, following procedures suggested by Beasley and Schumacker (1995) and García-Pérez and Núñez-Antón (2003). Logistic regression models will be used to estimate the predictive impact of the independent variables (engagement strategies) on the dependent variables (initial parental engagement measures).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2018
Actual
19/09/2018
Date of last participant enrolment
Anticipated
30/04/2019
Actual
3/11/2019
Date of last data collection
Anticipated
30/05/2019
Actual
8/12/2019
Sample size
Target
328
Accrual to date
Final
1606
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300083 0
University
Name [1] 300083 0
University of Queensland
Country [1] 300083 0
Australia
Primary sponsor type
University
Name
School of Psychology, University of Queensland
Address
University of Queensland, St Lucia, QLD 4072.
Country
Australia
Secondary sponsor category [1] 299484 0
Individual
Name [1] 299484 0
Carolina Gonzalez
Address [1] 299484 0
Parenting and Family Support Centre. 13 Upland Rd, St Lucia QLD 4072
Country [1] 299484 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300931 0
University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 300931 0
The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072 Australia
Ethics committee country [1] 300931 0
Australia
Date submitted for ethics approval [1] 300931 0
05/06/2018
Approval date [1] 300931 0
10/07/2018
Ethics approval number [1] 300931 0
2018001181

Summary
Brief summary
The purpose of this trial is to evaluate the effect of different engagement strategies in the early stages of parenting interventions, particularly recruitment, enrolment, and first attendance. To achieve this, the current trial is evaluating specific elements of two theories (i.e. Health Belief Model and Theory of Planned Behaviour) that have been explored previously in other studies. The results from this trial may inform which combination of format and message is a more effective engagement strategy compared to others. This information will be useful for researchers and practitioners in order to know what elements are more relevant to communicate to parents regarding how to consider parenting interventions as a source of support and thus benefit from them.
Trial website
https://exp.psy.uq.edu.au/parenting
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85318 0
Mrs Carolina Gonzalez
Address 85318 0
Parenting and Family Support Centre. 13 Upland Rd, St Lucia QLD 4072
Country 85318 0
Australia
Phone 85318 0
+61 7 3443 2567
Fax 85318 0
Email 85318 0
[email protected]
Contact person for public queries
Name 85319 0
Mrs Carolina Gonzalez
Address 85319 0
Carolina Gonzalez. Parenting and Family Support Centre. 13 Upland Rd, St Lucia QLD 4072
Country 85319 0
Australia
Phone 85319 0
+61 7 3443 2567
Fax 85319 0
Email 85319 0
[email protected]
Contact person for scientific queries
Name 85320 0
Mrs Carolina Gonzalez
Address 85320 0
Carolina Gonzalez. Parenting and Family Support Centre. 13 Upland Rd, St Lucia QLD 4072
Country 85320 0
Australia
Phone 85320 0
+61 7 3443 2567
Fax 85320 0
Email 85320 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
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Gonzalez, C., Morawska, A. & Haslam, D.M. The Impa... [More Details]

Documents added automatically
No additional documents have been identified.