Child DevelopmentSTTTNCT07666802
Sharing Tales That Teach: Shared Picturebook Reading for Early Childhood Emotional and Cognitive Development
A study testing Emotion-Focused Shared Picturebook Reading and Standard Dialogic Picturebook Reading in people with Child Development and Executive Functions (EF), run by University of Greenwich at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 48 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Executive Functions (EF), Emotion Regulation
- What is being tested?
- Emotion-Focused Shared Picturebook Reading and Standard Dialogic Picturebook Reading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Greenwich
London, SE10 9LS
Benjamin RG SIgsworth, MSc, 0044 020 8331 8000, benjamin.sigsworth@greenwich.ac.uk
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Emotion-Focused Shared Picturebook Reading, Standard Dialogic Picturebook Reading
- Keywords
- Emotion Regulation, Inhibitory Control, Cognitive Flexibility, Working Memory, Self-Control, Shared Reading, Dialogic Reading, Picturebooks, Early Childhood, Preschool Children, Caregiver-Child Dyads, Randomized Controlled Trial, Randomised Controlled Trial, Behavioural Intervention, Developmental Cognitive Neuroscience
- Medical subject headings
- Emotional Regulation, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion-Focused Shared Picturebook ReadingBehavioural
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.
Standard Dialogic Picturebook ReadingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Emotion-Focused Shared Picturebook Reading | Experimental | 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. Receives: Behavioral: Emotion-Focused Shared Picturebook Reading |
| Standard Dialogic Picturebook Reading | Active comparator | 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. Receives: Behavioral: Standard Dialogic Picturebook Reading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12-month follow-up
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startSep 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised, two-arm, parallel-group superiority trial embedded within a broader longitudinal cohort study. Caregiver-child dyads in the embedded trial subsample will be individually randomised in a 1:1 allocation ratio to either an emotion-focused shared picturebook reading intervention or a standard dialogic picturebook reading active control condition. Allocation will be maintained throughout the intervention period, with outcome assessments conducted at baseline and approximately 12 months later.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Greenwich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Sigsworth, University of Greenwich
- Investigators
- Benjamin RG Sigsworth, MSc, Principal investigator, University of GreenwichLaura Katus, PhD, Study director, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666802
- Sponsor's protocol ID
- STTT-UREB2026_42
- Acronym
- STTT
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07666802
- Acronym / sponsor ID
- STTT / STTT-UREB2026_42
- Keywords
- Emotion Regulation, Inhibitory Control, Cognitive Flexibility, Working Memory, Self-Control, Shared Reading, Dialogic Reading, Picturebooks
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of GreenwichUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomised, two-arm, parallel-group superiority trial embedded within a broader longitudinal cohort study. Caregiver-child dyads in the embedded trial subsample will be individually randomised in a 1:1 allocation ratio to either an emotion-focused shared picturebook reading intervention or a standard dialogic picturebook reading active control condition. Allocation will be maintained throughout the intervention period, with outcome assessments conducted at baseline and approximately 12 months later.
| Arm | Type | Receives |
|---|---|---|
| Emotion-Focused Shared Picturebook Reading | Experimental | Behavioral: Emotion-Focused Shared Picturebook ReadingArm 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. |
| Standard Dialogic Picturebook Reading | Active comparator | Behavioral: Standard Dialogic Picturebook ReadingCaregiver-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. |
Who may qualify
- Ages
- 48 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion-Focused Shared Picturebook ReadingAn 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. | Behavioural | Emotion-Focused Shared Picturebook Reading |
| Standard Dialogic Picturebook ReadingAn 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. | Behavioural | Standard Dialogic Picturebook Reading |
Primary outcome
Change in Child Emotion Regulation
Time frame: Baseline and 12-month follow-up
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.
Change in Child Emotion Regulation
Time frame: Baseline and 12-month follow-up
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.
Neural Correlates of Emotion Regulation electroencephalography (EEG) recordings
Time frame: Baseline and 12-month follow-up
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.
14 secondary outcomes
Child Inhibitory Control Accuracy: Flanker Visual Filtering Task
Time frame: Baseline and 12- month follow-up
Change in Child Cognitive Flexibility Accuracy Assessed by the Dimensional Change Card Sort Task
Time frame: Baseline and 12-month follow-up
Change in Child Working Memory Accuracy Assessed by the Working Memory Span Task
Time frame: Baseline and 12-month follow-up
Change in Caregiver-Reported Child Executive Function Assessed by the Childhood Executive Functioning Inventory
Time frame: Baseline and 12-month follow-up
Change in Caregiver Self-Efficacy
Time frame: Baseline and 12-month follow-up
Change in Caregiver Depression Anxiety and Stress
Time frame: Baseline and 12-month follow-up
Change in Caregiver Emotion Regulation Difficulties Assessed by the Difficulties in Emotion Regulation Scale Short Form
Time frame: Baseline and 12-month follow-up
Change in Caregiver Inhibitory Control Reaction Time Assessed by the Go/No-Go Task
Time frame: Baseline and 12-month follow-up
Change in Caregiver Cognitive Flexibility Reaction Time Assessed by the Alternate Switching Task
Time frame: Baseline and 12-month follow-up
Change in Caregiver Working Memory Reaction Time Assessed by the 2-Back Task
Time frame: Baseline and 12-month follow-up
Change in Child Executive Function Behaviours Assessed by the Executive Function from Observation and Reflection Tool Short Form
Time frame: Baseline and 12-month follow-up
Neural Correlates of Executive Function: ERP Indices of Cognitive Control and Response Inhibition
Time frame: Baseline and 12-month follow-up
Neural Correlates of Executive Function (EEG): ERP Indices of Attentional Processing
Time frame: Baseline and 12-month follow-up
Change in Caregiver Executive Function Difficulties Assessed by the Adult Executive Functioning Inventory
Time frame: Baseline and 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Child Development
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin RG Sigsworth, MSc principal investigator
University of Greenwich
Laura Katus, PhD study director
University of Greenwich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion-Focused Shared Picturebook Reading and Standard Dialogic Picturebook Reading in people with Child Development and Executive Functions (EF), run by University of Greenwich at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin RG Sigsworth, MSc (0044-20-8331-8000, benjamin.sigsworth@greenwich.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Emotion Regulation (time frame: Baseline and 12-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.