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Trial registered on ANZCTR
Registration number
ACTRN12624001410549
Ethics application status
Approved
Date submitted
25/10/2024
Date registered
29/11/2024
Date last updated
29/11/2024
Date data sharing statement initially provided
29/11/2024
Date results provided
29/11/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
A pilot randomised controlled trial investigating feasibility and acceptability of the prototype Daily Growth parenting program in parents/carers and their children aged 2-4 years
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Scientific title
A pilot randomised controlled trial investigating feasibility and acceptability of the prototype Daily Growth parenting program in parents/carers and their children aged 2-4 years
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Secondary ID [1]
312769
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
The current trial is a pilot study conducted in 2023, testing a prototype version of the Daily Growth parenting app. Findings from this pilot study informed the larger randomised controlled trial, currently underway with data collection planned 2025-26 (ACTRN12624000937516). A third non-randomised trial (ACTRN12624001023549) is planned at the completion of both trials (2026-7), to test a personalised algorithm in comparison to findings from the randomised controlled trial (ACTRN12624000937516).
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Health condition
Health condition(s) or problem(s) studied:
Emotion regulation
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Child mental health
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Child development
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Condition category
Condition code
Mental Health
331367
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0
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Depression
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Mental Health
331370
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0
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Studies of normal psychology, cognitive function and behaviour
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Mental Health
331369
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This pilot randomised controlled trial aimed to assess the feasibility and acceptability of a prototype for a novel parenting program aimed at improving community reach and engagement. The Daily Growth parenting program uses an ecological momentary intervention design, sending twice-daily 1-minute surveys, and offering 3-minute videos tailored to a specific parenting situation. The current study tested a small prototype version of Daily Growth. The final Daily Growth program will be offered as an app and offer parents/carers a combination of three different parenting programs over six weeks. However, this pilot study tested a prototype version via a web platform (not an app), offering just two of the three programs (Emotion Coaching; Active Play), each program offering 5 tailored 3-minute video resources (out of a planned 30 resources per program) over two weeks.
To participate, participants first registered to a web platform developed at Deakin University called 'Platform O', and then completed a baseline survey through Qualtrics (approx. 25 minutes). On completion of the baseline survey, participants were randomised to either a control or intervention group, via a random assignment (1:1 ratio) generator. Participants in both control and intervention condition were sent a 1-minute ‘pre’ ecological momentary intervention (pre-EMI) survey, at 7.30am and 7.30pm, every day for 2 weeks. The 1-minute EMI survey asked questions about parent and child emotion regulation and child emotions. Parents were also asked to select 1 of 5 challenging situations they had recently experienced (e.g., issues with eating). Participants in both control and intervention condition were offered an intervention if they reported that they or their child were experiencing negative affect or having difficulty regulating their emotions.
Parents in the intervention condition were randomised in-the-moment to receive 1 of 2 types of a micro-intervention (i.e., a 3-minute video), from either the Active Play program or the Emotion Coaching program. Regardless of the program they received, the 3-minute video was tailored to provide supportive advice specific to the parenting situation they had selected. Participants in the control condition were also sent a tailored link to the Raising Children Network government parenting website, directing them to a webpage that provided information specific to the parenting situation they had selected.
A post-EMI survey was sent to participants at 7:45am and 7:45pm. This survey repeated the same items asking about parents' emotion regulation and their children's emotions (but did not repeat the question about challenging parenting situations). Finally, at the end of 2 weeks, parents were asked to complete a 25-minute post-intervention survey.
Due to a technical problem, approximately half of the sample enrolled in this pilot experienced an issue. Programming for the post-EMI survey required that participants must have completed their pre-EMI survey within 15 minutes of receiving the invitation email. This unfortunately meant that most participants did not reliably receive the post-EMI survey throughout the two-week period. This technical problem was identified and corrected half-way through the trial to remove the time-requirement – participants were not required to complete the pre-survey within 15 minutes (the survey was available all day), and the post EMI survey prompt was sent to all Group 2 participants, regardless of their cut-point score on the pre-survey. Given that our data analyses focussed on describing survey completion rates, we separated participants affected by this technical problem (Group 1) with those enrolled later in the study and not affected (Group 2). We note that there were no other differences between these groups, and that there were roughly equal representation of control and intervention conditions across Groups 1 and 2.
Daily Growth Program Resources
Emotion Coaching
The Emotion Coaching program in Daily Growth focuses on teaching children the soft skills needed in the modern world to succeed. Emotion Coaching teaches parents how to notice their own emotions; to understand their child’s needs; to notice, accept, and label all of their child’s emotions; and to empathise and connect with their child. It also teaches parents how to reflect on behaviour they regret, take responsibility, make amends, and model these skills to their child.
Active Play
The Active Play program offers a set of games to help children connect with their body. Active Play draws on scientific evidence showing how physical activity and play can be used to manage stress and difficult emotions, as well as promoting brain development. The games are designed to help children move in ways that support their emotional and physical development, while also having fun, and connecting with parents.
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Intervention code [1]
329337
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Behaviour
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Intervention code [2]
329335
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Prevention
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Intervention code [3]
329336
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Treatment: Other
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Comparator / control treatment
Control participants did not receive a microintervention video. Instead, they were directed to an Australian government parenting website, the Raising Children Network, a free website overseen by the Department of Social Services that provides age-appropriate and evidence-based parenting advice for the Australian public. The specific webpage parents were directed to was tailored to the challenging parenting situation they were experiencing.
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Control group
Active
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Outcomes
Primary outcome [1]
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Child emotion regulation.
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Assessment method [1]
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Early Emotion Regulation Behaviour Questionnaire.
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Timepoint [1]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Primary outcome [2]
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Parent emotion regulation.
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Assessment method [2]
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Difficulties in Emotion Regulation Scale.
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Timepoint [2]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [1]
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Children's anxiety.
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Assessment method [1]
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Short-Form Spence Children's Anxiety Scale.
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Timepoint [1]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [2]
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Parents' beliefs about children’s emotions.
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Assessment method [2]
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Parents' Beliefs about Children’s Emotions Questionnaire.
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Timepoint [2]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [3]
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Children's negative affect.
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Assessment method [3]
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Positive and Negative Affect Schedule for Children.
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Timepoint [3]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [4]
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Acceptability.
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Assessment method [4]
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User satisfaction survey, developed by the research team of the current study.
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Timepoint [4]
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Assessed at the conclusion of the two-week intervention period.
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Secondary outcome [5]
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Children's behavioural problems.
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Assessment method [5]
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Multidimensional Assessment of Preschool Disruptive Behaviour.
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Timepoint [5]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [6]
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Family emotional climate.
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Assessment method [6]
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Self-Expressiveness in the Family Questionnaire.
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Timepoint [6]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [7]
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Engagement.
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Assessment method [7]
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Engagement was measured by determining the proportion of available EMI prompts completed by each parent, the time-of-day responses were logged, and parent-reported barriers affecting engagement.
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Timepoint [7]
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Cumulative data assessed at the conclusion of the recruitment period.
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Secondary outcome [8]
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Parent positive and negative affect.
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Assessment method [8]
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International Positive and Negative Affect Scale.
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Timepoint [8]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [9]
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Children's depression.
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Assessment method [9]
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Short Mood and Feelings Questionnaire.
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Timepoint [9]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [10]
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Parent stress.
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Assessment method [10]
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Depression, Anxiety and Stress Scale.
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Timepoint [10]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [11]
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Emotion-related parenting.
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Assessment method [11]
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Short-Form Coping with Toddlers' Negative Emotions Scale.
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Timepoint [11]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [12]
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Parental reflective functioning.
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Assessment method [12]
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Parental Reflective Functioning Questionnaire.
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Timepoint [12]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [13]
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Recruitment rates.
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Assessment method [13]
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The percentage of eligible participants who completed the baseline survey from all individuals who clicked on the baseline survey link; and the number of parents who completed the baseline survey.
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Timepoint [13]
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Cumulative data assessed at the conclusion of the recruitment period.
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Secondary outcome [14]
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Parent psychological distress.
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Assessment method [14]
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Kessler Psychological Distress Scale.
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Timepoint [14]
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Assessed at baseline, and at the conclusion of the two-week intervention period.
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Secondary outcome [15]
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Retention.
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Assessment method [15]
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Retention was evaluated by examining attrition rates, measured as participant drop-out and withdrawal throughout the 2-week study period (i.e., between completing the baseline and post-intervention surveys).
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Timepoint [15]
441816
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Assessed with data collected at baseline, and at the conclusion of the two-week intervention period.
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Eligibility
Key inclusion criteria
Participants were eligible to participate if they were a resident of Australia, 18 years or older, and a current parent (i.e., biological, step, etc.) of a child aged 2 to 4 years.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
All information related to the study, such as recruitment materials, app content, and surveys, was written in English. While non-English speakers were not explicitly excluded, only English speakers could participate, based on their ability to comprehend the advertisements and provide informed consent.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Participant's responses to the baseline, post-surveys, and daily EMI surveys were analysed with descriptive statistics in order to summarise recruitment, retention and engagement rates.
Pearson pairwise associations were tested between demographic characteristics and level of engagement with pre-and-post-EMI surveys and the post-survey.
To assess program acceptability, user satisfaction items that were included in the post-survey were analysed using descriptive statistics.
To assess feasibility in the context of condition changes and differences, Bonferroni-adjusted linear regression analyses were conducted for parent and child outcomes. In each model, parents' condition - intervention versus control, was included as the independent variables (i.e., a categorical variable); and a post-outcome variable was included as a dependent variable, such as parents' emotion regulation
Pre- and post-EMI daily survey data were analysed using linear mixed-effects regression models. These models included fixed effects (to control for group and timepoint) and random effects (to control for individual variations over time). Robust standard errors controlled for the clustering of observations within participants.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
17/03/2023
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Date of last participant enrolment
Anticipated
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Actual
4/04/2023
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Date of last data collection
Anticipated
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Actual
18/04/2023
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Sample size
Target
150
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Accrual to date
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Final
184
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Deakin University
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319527
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Address [1]
319527
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Country [1]
319527
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315940
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Deakin University Human Research Ethics Committee (DUHREC)
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Ethics committee address [1]
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https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/11/2022
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Approval date [1]
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09/01/2023
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Ethics approval number [1]
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HEAG-H 188_2022
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Summary
Brief summary
The research project conducted a randomised controlled trial in March-April 2023 to assess the feasibility and acceptability of EMI survey delivery and a small prototype of the Daily Growth program. This pilot evaluated ten prototype parenting resources (5 x Emotion Coaching; 5 x Active Play) offered to parents over two weeks delivered via a web platform. Specifically, the project aimed to test: 1. The feasibility of the prototype version of Daily Growth in terms of parent recruitment rates, retention, and flow through the stages of the study, as well as parent engagement via completion rates of the baseline survey, post-study survey, and daily prompts. 2. The acceptability of the ten prototype video resources and the program delivery method via twice-daily pre- and post-EMI prompts. 3. The feasibility of the prototype version of the Daily Growth program and the evaluation process in improving parent/child emotion regulation, mental health, and emotion coaching parenting behaviours in-the-moment and post-intervention compared to the control condition.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Elizabeth Westrupp
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Address
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Deakin University, 221 Burwood Highway, Burwood, VIC 3125
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Country
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Australia
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Phone
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+61 3 9246 8974
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Elizabeth Westrupp
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Address
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Deakin University, 221 Burwood Highway, Burwood, VIC 3125
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Country
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Australia
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Phone
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+61 3 9246 8974
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Elizabeth Westrupp
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Address
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Deakin University, 221 Burwood Highway, Burwood, VIC 3125
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Country
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Australia
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Phone
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+61 3 9246 8974
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Non-identifiable data will be publicly available on public data repositories.
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
All participant data will be shared on public data repositories (such as the Open Science Framework) after they have been made non-identifiable.
What types of analyses could be done with individual participant data?
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Data will be available for any type of analyses.
When can requests for individual participant data be made (start and end dates)?
From:
Data will be available immediately after initial results have been published, with no end date.
To:
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Where can requests to access individual participant data be made, or data be obtained directly?
•
Data will be available on the Open Science Framework (https://osf.io) and the Australian Data Archive (https://ada.edu.au). The PI of the current trial (Assoc. Prof. Elizabeth Westrupp) can be contacted for information regarding data sharing. Email:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
ANZCTR_basic_results_21.10.24.docx
Documents added automatically
No additional documents have been identified.
Download to PDF