Sharing Tales That Teach: Shared Picturebook Reading for Early Childhood Emotional and Cognitive Development (STTT)

Sharing Tales That Teach: An RCT of Emotion-Focused Shared Picturebook Reading Versus Standard Dialogic Reading to Support Emotion Regulation and Executive Function in Caregiver-Child Dyads

Sharing Tales That Teach is a randomised study of a shared picturebook reading programme for 4- to 5-year-old children and their primary caregivers. The study will test whether a caregiver-delivered, emotion-focused shared reading programme leads to greater improvements in children's emotion regulation than a standard dialogic shared reading programme.

Emotion regulation refers to children's developing ability to understand, express and manage emotions in ways that support learning, relationships and wellbeing. These skills are closely linked with executive function, including children's ability to remember instructions, control impulses and shift flexibly between activities. Shared picturebook reading may provide a natural, low-cost way for caregivers to support these skills through everyday interaction.

Families in the randomised part of the study will be allocated to one of two 8-week shared reading programmes. In the emotion-focused group, caregivers will receive training in strategies such as naming emotions, discussing why characters feel as they do, talking about consequences of emotions and modelling ways to manage feelings. In the comparison group, caregivers will receive training in standard dialogic picturebook reading strategies, such as naming, describing, sequencing and asking open questions, without an explicit focus on emotions or emotion regulation. Both groups will use the same picturebooks and will be asked to complete three shared reading sessions per week at home.

The main hypothesis is that children in the emotion-focused shared reading group will show greater improvement in emotion regulation from baseline to 12-month follow-up than children in the standard dialogic shared reading group. The study will also examine whether the programme affects children's executive function, caregiver wellbeing and caregiver emotion regulation. Additional exploratory analyses will examine caregiver-child interaction processes and whether caregiver or child characteristics are associated with different intervention effects.

The study will recruit caregiver-child dyads through state primary schools in Greater London. Children will complete age-appropriate tasks and caregivers will complete questionnaires at baseline and follow-up. A laboratory subsample may also complete additional behavioural, observational and neurophysiological assessments. The study is low risk, non-invasive and does not involve medical treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Child Development; Emotion Regulation; Executive Functions (EF)
• Intervention / Treatment: Behavioral: Emotion-Focused Shared Picturebook Reading; Behavioral: Standard Dialogic Picturebook Reading

Detailed Description

Sharing Tales That Teach is a two-arm, parallel-group randomised controlled trial of a caregiver-delivered shared picturebook reading intervention for young children and their primary caregivers. The trial is embedded within a broader longitudinal cohort study examining the development of emotion regulation and executive function across the transition from Reception to Year 1.

The study is grounded in developmental evidence that emotion regulation and executive function are closely related capacities during early childhood. Emotion regulation supports children's ability to understand, express and manage emotional states, while executive function supports goal-directed behaviour through working memory, inhibitory control and cognitive flexibility. Shared picturebook reading is used as the intervention context because it provides a naturalistic setting in which caregivers can scaffold language, attention, emotional understanding and self-regulatory strategies through everyday interaction.

Participants in the randomised subsample will be individually allocated at the caregiver-child dyad level to either an emotion-focused shared picturebook reading intervention or a standard dialogic picturebook reading active control condition. The active comparator is designed to control for shared reading exposure, caregiver attention, receipt of training materials and use of the same picturebooks, while excluding explicit emotion-focused and mental-state scaffolding. This design is intended to assess whether any observed benefit is attributable to the emotion-focused components of the intervention rather than to shared reading exposure alone.

Both conditions will be delivered by caregivers in the family home over an 8-week period. Caregivers in the emotion-focused condition will receive standardised training materials introducing strategies such as emotion labelling, discussion of emotional causes and consequences, modelling of regulatory strategies and reflective questioning. Caregivers in the standard dialogic reading condition will receive training in narrative and dialogic reading techniques, including naming, describing, sequencing and encouraging child participation through open-ended questions. Families in both groups will be asked to complete three shared reading sessions per week and will continue with usual educational provision and typical home or school activities.

Assessments will be conducted at baseline and approximately 12 months later. Home-based assessments will include age-appropriate child behavioural tasks and caregiver-completed questionnaires. A laboratory subsample will complete additional behavioural, observational and neurophysiological assessments at the University of Greenwich, including EEG/ERP measures where appropriate and tolerable for the child. Caregiver-child interaction tasks will be recorded and coded to examine features such as emotion talk, joint attention, turn taking and scaffolding. Audio recordings of the first and final home reading sessions will be collected to support assessment of intervention fidelity and differentiation between conditions.

The primary analytic focus is the comparison between trial arms on change in child emotion regulation from baseline to 12-month follow-up. Secondary analyses will examine change in child executive function, caregiver wellbeing and caregiver emotion regulation. Exploratory analyses will examine caregiver-child interaction processes and whether caregiver or child characteristics are associated with variation in intervention response.

The wider cohort will aim to recruit approximately 400 caregiver-child dyads. The embedded randomised trial will include approximately 200 dyads, with around 100 allocated to each condition. Analyses will follow an intention-to-treat framework, with participants analysed according to their original allocation regardless of intervention adherence. Longitudinal multilevel models and latent growth curve approaches will be used to estimate developmental change and compare trajectories between conditions. Models will adjust for relevant baseline variables where appropriate and account for school-level clustering where needed.

The study is low risk, non-invasive and educational in nature. No serious adverse events are anticipated. Potential minor risks include tiredness, boredom, frustration or brief distress during assessments, and possible sensory discomfort during EEG procedures for children in the laboratory subsample. Participant wellbeing, retention, data completeness, protocol adherence and adverse events will be monitored by the primary researcher in consultation with the supervisory team. No formal Data Monitoring Committee or interim efficacy analysis is planned. Data will be pseudonymised, stored securely on University of Greenwich systems and handled in accordance with UK data protection requirements and the approved ethics protocol.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin RG Sigsworth, MSc; Phone Number: 0044-20-8331-8000; Email: benjamin.sigsworth@greenwich.ac.uk
• Study Contact Backup: Name: Laura Katus, PhD; Phone Number: 0044-20-8331-8000; Email: l.Katus@greenwich.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE10 9LS
    • University of Greenwich
    • Contact: Benjamin RG SIgsworth, MSc; Phone Number: 0044 020 8331 8000; Email: benjamin.sigsworth@greenwich.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Child aged 4 to 5 years at baseline assessment
• Child enrolled in a participating state primary school
• At least one primary caregiver willing to participate in shared reading activities and study assessments
• Caregiver has sufficient proficiency in English to engage with intervention materials and questionnaires

Exclusion Criteria:

• Child has an identified sensory impairment, such as uncorrected hearing or vision difficulties, that would impede engagement with study tasks
• Family is unable to commit to baseline and follow-up assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotion-Focused Shared Picturebook Reading; Arm Description: Caregiver-child dyads allocated to this arm will receive an 8-week caregiver-delivered shared picturebook reading programme designed to support children's emotion regulation within everyday reading interactions. Caregivers will receive standardised training materials introducing emotion-focused scaffolding strategies, including emotion labelling, discussion of emotional causes and consequences, modelling of regulatory strategies and reflective questioning. Families will be asked to complete three shared reading sessions per week at home using age-appropriate picturebooks.	Behavioral: Emotion-Focused Shared Picturebook Reading; An 8-week caregiver-delivered shared picturebook reading programme designed to support emotion regulation in 4- to 5-year-old children. Caregivers receive standardised training materials, delivered through short instructional videos, introducing emotion-focused scaffolding strategies during shared reading. Strategies include emotion labelling, discussion of emotional causes and consequences, modelling of regulatory strategies and reflective questioning. Families are provided with age-appropriate picturebooks and asked to complete three shared reading sessions per week at home. Weekly feedback forms and audio recordings of the first and final sessions are used to support monitoring of engagement and fidelity.
Active Comparator: Standard Dialogic Picturebook Reading; Caregiver-child dyads allocated to this arm will receive an 8-week shared picturebook reading programme matched in duration, materials and caregiver involvement, but without explicit emotion-focused content. Caregivers will receive standardised training in standard dialogic and narrative reading strategies, including naming, describing, sequencing and encouraging child participation through open-ended questions. Families will use the same picturebooks as the intervention group and will be asked to complete three shared reading sessions per week at home.	Behavioral: Standard Dialogic Picturebook Reading; An 8-week caregiver-delivered shared picturebook reading programme used as an active comparator. Caregivers receive standardised training materials introducing dialogic and narrative reading strategies, including naming, describing, sequencing and encouraging child participation through open-ended questions. The comparator is matched to the emotion-focused intervention for duration, materials and caregiver involvement, but does not include explicit training in emotion recognition, emotional states or regulation strategies. Families use the same picturebooks as the experimental arm and are asked to complete three shared reading sessions per week at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child Emotion Regulation	Caregiver report using the Emotion Regulation Checklist (ERC) The ERC Adaptive Emotion Regulation total scores range from 23 to 92, higher scores indicating better emotion regulation.	Baseline and 12-month follow-up
Change in Child Emotion Regulation	Self-Assessment of Young children's FEELings and emotion regulation - SAY-FEEL Adaptive Emotion Regulation scores range from 11 to 33, higher scores indicating stronger self-reported emotion regulation.	Baseline and 12-month follow-up
Neural Correlates of Emotion Regulation electroencephalography (EEG) recordings	Resting-state frontal alpha asymmetry. Resting-state electroencephalography (EEG) recordings will be collected during eyes-open, eyes-closed, and passive video-viewing conditions. Frontal alpha asymmetry, calculated from alpha-band power at homologous frontal electrode sites, will serve as the primary EEG-derived outcome measure. Frontal alpha asymmetry has been associated with emotion regulation, affective control, and emotional reactivity in early childhood.	Baseline and 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Inhibitory Control Accuracy: Flanker Visual Filtering Task	Each trial children will indicate the direction of a centre fish while ignoring surrounding fish. Incompatible trials are trials where the surrounding fish face the opposite direction to the centre fish. The reported score is the percentage of incompatible trials answered correctly, ranging from 0% to 100%. Higher scores indicate better inhibitory control.	Baseline and 12- month follow-up
Change in Child Cognitive Flexibility Accuracy Assessed by the Dimensional Change Card Sort Task	Child cognitive flexibility will be assessed using the Dimensional Change Card Sort task, a behavioural measure of flexible rule use in early childhood. Children are asked to sort bivalent stimuli according to one rule, such as colour, before switching to a conflicting rule, such as shape. The reported outcome will be the percentage of trials sorted correctly on trials requiring flexible rule use, including post-switch and, where administered, border or mixed-rule trials. Scores range from 0% to 100%. Higher scores indicate stronger cognitive flexibility performance.	Baseline and 12-month follow-up
Change in Child Working Memory Accuracy Assessed by the Working Memory Span Task	Child working memory will be using the Working Memory Span task, a behavioural task that indexes working memory in early childhood. Children are shown visual stimuli containing animals, colours and houses, and are asked to hold animal information in mind while completing a naming demand. The reported outcome will be the percentage of working memory recall trials answered correctly, ranging from 0% to 100%. Higher scores indicate stronger working memory performance.	Baseline and 12-month follow-up
Change in Caregiver-Reported Child Executive Function Assessed by the Childhood Executive Functioning Inventory	The Childhood Executive Functioning Inventory is a 26-item questionnaire assessing everyday executive function behaviours, particularly working memory and inhibition. Items are rated on a 1 to 5 scale, giving a total score range of 26 to 130. Higher scores indicate greater executive function difficulties. Change from baseline to 12-month follow-up will be compared between trial arms.	Baseline and 12-month follow-up
Change in Caregiver Self-Efficacy	The Brief Parental Self-Efficacy Scale ranges from 5 to 25, with higher scores indicating greater parental/caregiver self-efficacy.	Baseline and 12-month follow-up
Change in Caregiver Depression Anxiety and Stress	The Depression Anxiety Stress Scales - 21 Items total score ranges from 0 to 126, with higher scores indicating greater psychological distress.	Baseline and 12-month follow-up
Change in Caregiver Emotion Regulation Difficulties Assessed by the Difficulties in Emotion Regulation Scale Short Form	The self-report scale includes 18 items across six domains: nonacceptance of emotional responses, difficulties engaging in goal-directed behaviour, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies and lack of emotional clarity. Each item is scored from 1 to 5, producing a total score ranging from 18 to 90. Higher scores indicate greater emotion regulation difficulties. Change from baseline to 12-month follow-up will be compared between trial arms.	Baseline and 12-month follow-up
Change in Caregiver Inhibitory Control Reaction Time Assessed by the Go/No-Go Task	Caregiver inhibitory control will be assessed using the computerised Go/No-Go Task. Participants respond to Go trials and withhold responses on No-Go trials. The tasks includes 60 trials. The reported outcome will be mean reaction time across task trials, measured in milliseconds. Lower scores indicate faster inhibitory control performance. Change from baseline to 12-month follow-up will be compared between trial arms.	Baseline and 12-month follow-up
Change in Caregiver Cognitive Flexibility Reaction Time Assessed by the Alternate Switching Task	Caregiver cognitive flexibility will be assessed using the computerised Alternate Switching Task. Participants respond according to either the colour or shape of visual stimuli, depending on where the stimulus appears on screen. The task includes 64 trials. The reported outcome will be mean reaction time across task trials, measured in milliseconds. Lower scores indicate faster cognitive flexibility performance. Change from baseline to 12-month follow-up will be compared between trial arms.	Baseline and 12-month follow-up
Change in Caregiver Working Memory Reaction Time Assessed by the 2-Back Task	Caregiver working memory will be assessed using the computerised 2-back task. Participants indicate whether each presented letter matches the letter shown two trials earlier. The task consists 58 trials The reported outcome will be mean reaction time across task trials, measured in milliseconds. Lower scores indicate faster working memory performance. Change from baseline to 12-month follow-up will be compared between trial arms.	Baseline and 12-month follow-up
Change in Child Executive Function Behaviours Assessed by the Executive Function from Observation and Reflection Tool Short Form	Change in Child Executive Function Behaviours Assessed by the Executive Function from Observation and Reflection Tool Short Form Child executive function behaviours will be assessed using caregiver report on the Executive Function from Observation and Reflection Tool short form. The short form includes 12 items assessing everyday executive function behaviours, including attention, inhibitory control, working memory, cognitive flexibility and planning/organisation. Each item is scored from 1 to 4, producing a total score ranging from 12 to 48. Higher scores indicate stronger child executive function behaviours. Change from baseline to 12-month follow-up will be compared between trial arms.	Baseline and 12-month follow-up
Neural Correlates of Executive Function: ERP Indices of Cognitive Control and Response Inhibition	ERP Indices of Cognitive Control and Response Inhibition Outcome Measure: Amplitude and latency of pre-specified event-related potential (ERP) components elicited during a child-friendly cognitive control task (e.g., N2, P3). Description: EEG will be recorded during a cognitive control paradigm. ERP component mean amplitudes and noise-corrected peak latencies associated with cognitive control and response inhibition will be examined as neural markers of executive functioning.	Baseline and 12-month follow-up
Neural Correlates of Executive Function (EEG): ERP Indices of Attentional Processing	Amplitude and latency of pre-specified ERP components elicited during an auditory oddball paradigm (e.g., P3, Nc component). Description: EEG will be recorded during an auditory oddball task. ERP component mean amplitudes and noise-corrected peak latencies reflecting attentional processing will be examined and explored in relation to executive functioning.	Baseline and 12-month follow-up
Change in Caregiver Executive Function Difficulties Assessed by the Adult Executive Functioning Inventory	Caregiver executive function difficulties will be assessed using the Adult Executive Functioning Inventory, a 14-item self-report questionnaire assessing everyday executive function difficulties in working memory and inhibitory control. Each item is scored from 1 to 5, producing a total score ranging from 14 to 70. Higher scores indicate greater executive function difficulties.	Baseline and 12-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Weekly Number of Shared Reading Sessions Paused or Stopped Due to Child Unwillingness as Assessed by Weekly Caregiver Feedback Form	Child willingness to continue shared reading will be assessed using a weekly caregiver feedback form. Caregivers will report whether any session was paused or stopped because the child did not wish to continue. Where this occurred, caregivers will report the number of affected sessions. Scores range from 0 to 3 sessions per week. Higher scores indicate more frequent session discontinuation due to child unwillingness.	Weekly during the 8-week intervention period
Intervention Fidelity and Engagement	Intervention fidelity and engagement will be assessed using weekly caregiver feedback forms and audio recordings of the first and final home shared-reading sessions. These data will be used to describe intervention dose, engagement, adherence to assigned condition and differentiation between the emotion-focused and standard dialogic reading conditions.	Weekly during the 8-week intervention period, with audio recordings from the first and final home shared-reading sessions
Rate of Caregiver Emotion Talk During Caregiver-Child Shared Reading	Caregiver emotion talk will be defined as caregiver verbal references to emotions, feelings, emotional causes, emotional consequences or emotion regulation strategies. The reported outcome will be the rate of caregiver emotion talk, calculated as the number of coded caregiver emotion-talk utterances divided by the duration of the shared-reading interaction in minutes. Scores have a minimum value of 0, with no fixed maximum. Higher values indicate more frequent caregiver emotion talk during shared reading.	Baseline and 12-month follow-up laboratory shared-reading interaction tasks, with additional process data from the first and final home shared-reading sessions during the 8-week intervention period
Rate of Joint Attention Episodes During Caregiver-Child Shared Reading	Joint attention will be assessed through observational coding of caregiver-child shared-reading interactions. Joint attention episodes will be defined as coded instances in which the caregiver and child show coordinated attention to the same book-related object, image, character or event. The reported outcome will be the rate of joint attention episodes, calculated as the number of coded joint attention episodes divided by the duration of the shared-reading interaction in minutes. Scores have a minimum value of 0, with no fixed maximum. Higher values indicate more frequent joint attention during shared reading. Time Frame:	Baseline and 12-month follow-up laboratory shared-reading interaction tasks, with additional process data from the first and final home shared-reading sessions during the 8-week intervention period
Rate of Child Emotion Talk During Caregiver-Child Shared Reading	Child emotion talk will be defined as child verbal references to emotions, feelings, emotional causes, emotional consequences or emotion regulation strategies. The reported outcome will be the rate of child emotion talk, calculated as the number of coded child emotion-talk utterances divided by the duration of the shared-reading interaction in minutes. Scores have a minimum value of 0, with no fixed maximum. Higher values indicate more frequent child emotion talk during shared reading.	Baseline and 12-month follow-up laboratory shared-reading interaction tasks, with additional process data from the first and final home shared-reading sessions during the 8-week intervention period
Rate of Turn-Taking Exchanges During Caregiver-Child Shared Reading	Turn-taking will be assessed through observational coding of caregiver-child shared-reading interactions. Turn-taking exchanges will be defined as coded reciprocal verbal or non-verbal exchanges between the caregiver and child during the shared-reading interaction. The reported outcome will be the rate of turn-taking exchanges, calculated as the number of coded turn-taking exchanges divided by the duration of the shared-reading interaction in minutes. Scores have a minimum value of 0, with no fixed maximum. Higher values indicate more frequent turn-taking during shared reading.	Baseline and 12-month follow-up laboratory shared-reading interaction tasks, with additional process data from the first and final home shared-reading sessions during the 8-week intervention period
Rate of Caregiver Scaffolding Behaviours During Caregiver-Child Shared Reading	Caregiver scaffolding behaviours will be assessed through observational coding of caregiver-child shared-reading interactions. Scaffolding behaviours will be defined as caregiver behaviours that support the child's engagement, understanding or reflection during shared reading, including prompts, questions, elaborations, contingent responses and support for participation. The reported outcome will be the rate of caregiver scaffolding behaviours, calculated as the number of coded scaffolding behaviours divided by the duration of the shared-reading interaction in minutes. Scores have a minimum value of 0, with no fixed maximum. Higher values indicate more frequent caregiver scaffolding during shared reading.	Baseline and 12-month follow-up laboratory shared-reading interaction tasks, with additional process data from the first and final home shared-reading sessions during the 8-week intervention period
Mean Weekly Number of Shared Reading Sessions Completed as Assessed by Weekly Caregiver Feedback Form	Intervention adherence will be assessed using a weekly caregiver feedback form. Caregivers will report how many shared reading sessions they completed during the previous week. Scores range from 0 to 3 sessions per week. Higher scores indicate greater adherence to the shared reading schedule.	Weekly during the 8-week intervention period
Mean Weekly Caregiver Enjoyment Score as Assessed by Weekly Caregiver Feedback Form	Caregiver acceptability will be assessed using a weekly caregiver feedback form. Caregivers will rate how much they enjoyed the shared reading sessions during the previous week. Scores range from 1 to 5, where 1 indicates not at all and 5 indicates very much. Higher scores indicate greater caregiver acceptability.	Weekly during the 8-week intervention period
Mean Weekly Ease-of-Fitting-Sessions Score as Assessed by Weekly Caregiver Feedback Form	Intervention feasibility will be assessed using a weekly caregiver feedback form. Caregivers will rate how easy it was to fit the shared reading sessions into their week. Scores range from 1 to 5, where 1 indicates very difficult and 5 indicates very easy. Higher scores indicate greater perceived feasibility.	Weekly during the 8-week intervention period
Mean Weekly Caregiver-Reported Child Enjoyment Score as Assessed by Weekly Caregiver Feedback Form	Child acceptability and engagement will be assessed using a weekly caregiver feedback form. Caregivers will rate how much their child seemed to enjoy the story or stories during the previous week. Scores range from 1 to 5, where 1 indicates not at all and 5 indicates very much. Higher scores indicate greater caregiver-reported child enjoyment and engagement.	Weekly during the 8-week intervention
Mean Weekly Shared Reading Session Duration Category as Assessed by Weekly Caregiver Feedback Form	Intervention dose will be assessed using a weekly caregiver feedback form. Caregivers will report the average duration of shared reading sessions completed during the previous week using five ordered response categories: less than 5 minutes, 5 to 10 minutes, 10 to 15 minutes, 15 to 20 minutes and more than 20 minutes. Scores range from 1 to 5, with higher scores indicating longer average session duration.	Weekly during the 8-week intervention period

Collaborators and Investigators

• Sponsor: University of Greenwich
• Investigators: Principal Investigator: Benjamin RG Sigsworth, MSc, University of Greenwich; Study Director: Laura Katus, PhD, University of Greenwich

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Emotion Regulation; Working Memory; Randomised Controlled Trial; Cognitive Flexibility; Early Childhood; Preschool Children; Inhibitory Control; Behavioural Intervention; Self-Control; Dialogic Reading; Shared Reading; Picturebooks; Caregiver-Child Dyads; Developmental Cognitive Neuroscience
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Self-Control; Emotional Regulation
• Other Study ID Numbers: STTT-UREB2026_42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the primary analyses will be made available, together with a data dictionary and statistical code, where this is consistent with ethical approval, participant consent and data protection requirements. Identifiable personal data, including names, contact details, audio recordings, video recordings and any material that could directly or indirectly identify participants, will not be shared openly.
• IPD Sharing Time Frame: Data and supporting information will become available following completion of the primary analyses and dissemination of the main study findings. Availability will be subject to ethical approval, participant consent, data protection requirements and repository arrangements.
• IPD Sharing Access Criteria: Access to de-identified clean datasets will be provided upon reasonable request for purposes of research transparency and reproducibility. Requests will be reviewed by the principal investigator, in consultation with the supervisory team, to ensure consistency with the approved ethics protocol, participant consent and data protection requirements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No