NCT07666802

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

June 4, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

Emotion RegulationInhibitory ControlCognitive FlexibilityWorking MemorySelf-ControlShared ReadingDialogic ReadingPicturebooksEarly ChildhoodPreschool ChildrenCaregiver-Child DyadsRandomized Controlled TrialRandomised Controlled TrialBehavioural InterventionDevelopmental Cognitive Neuroscience

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (14)

  • Child Inhibitory Control Accuracy: Flanker Visual Filtering Task

    Baseline and 12- month follow-up

  • Change in Child Cognitive Flexibility Accuracy Assessed by the Dimensional Change Card Sort Task

    Baseline and 12-month follow-up

  • Change in Child Working Memory Accuracy Assessed by the Working Memory Span Task

    Baseline and 12-month follow-up

  • Change in Caregiver-Reported Child Executive Function Assessed by the Childhood Executive Functioning Inventory

    Baseline and 12-month follow-up

  • Change in Caregiver Self-Efficacy

    Baseline and 12-month follow-up

  • +9 more secondary outcomes

Other Outcomes (12)

  • Mean Weekly Number of Shared Reading Sessions Paused or Stopped Due to Child Unwillingness as Assessed by Weekly Caregiver Feedback Form

    Weekly during the 8-week intervention period

  • Intervention Fidelity and Engagement

    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

    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

  • +9 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Standard Dialogic Picturebook Reading

Interventions

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.

Emotion-Focused Shared 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.

Standard Dialogic Picturebook Reading

Eligibility Criteria

Age48 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Greenwich

London, SE10 9LS, United Kingdom

Location

MeSH Terms

Conditions

Emotional RegulationSelf-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Benjamin RG Sigsworth, MSc

    University of Greenwich

    PRINCIPAL INVESTIGATOR
  • Laura Katus, PhD

    University of Greenwich

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Caregivers and children will not be masked to allocation because the intervention is behavioural and the instructional content differs between conditions. Both study conditions will be presented neutrally as shared-reading programmes and delivered through standardised video materials to minimise expectancy effects. Outcome assessors responsible for scoring behavioural tasks, EEG/ERP data and observational measures will be blinded to group allocation. Data analysts will use anonymised group codes during the primary analyses, with allocation revealed only after the primary analysis code has been finalised.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
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.
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.

Locations