Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years (B-READY)

April 12, 2026 updated by: Shaun Goh Kok Yew, Nanyang Technological University
This research aims to ask (1) Are child and parent measures of coping skills, anxiety and other outcomes reliable (2) How feasible and acceptable is the proposed CB preventative program and protocol (3) Can a preliminary indication of efficacy for CB preventative program be provided.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National Institute of Education, Nanyang Technological University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Currently be enrolled in K1 or K2 in preschool.
  • Singaporean Citizen or of Permanent Resident status
  • Parent of study's participant has to have read a book with participant at least once in the last 6 months.

Exclusion Criteria:

  • Not currently enrolled in a child support programme
  • Not currently receiving medication for mental health concerns
  • Not currently receiving support from a Speech Language Therapist or Psychologist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: LANG-arm
The comparator, LANG-arm, consists of 4 storybooks with accompanying audioplayer. These are provided to parents of participants to complete with their child. Each storybook explicitly teaches the story structure of problem, followed by goal & action, and then by outcome, repeated across storybooks. There are 8 target words that are repeated and taught throughout the programme, which are different words from the CB-arm. Each of the 4 storybooks is read twice per week, resulting in 8 sessions, which are expected to last between 15-20 minutes each.
Device: Language
Storybook reading with an emphasis on specific word vocabulary and narrative structure serving as a control, for preschool children
Experimental: CB-arm
The CB-arm consists of 4 storybooks with accompanying audio narration file. These are provided to parents of participants to complete with their child. Each storybook focuses on one cognitive behavioural strategy, namely relaxation, social skills, exposure and cognitive techniques, while all books include psychoeducation. Each CBT element is linked to two words for a total of 8 target words, which are repeated across the storybooks. Each storybook follows a 'feeling-problem-solution' narrative structure. Storybooks also contain descriptions of CBT elements, and questions guiding parents to practice these with their children. Each of the 4 storybooks is read twice per week, resulting in 8 sessions, which are expected to last between 15-20 minutes each.
Device: Cognitive Behavioural
Cognitive behavioural therapy incorporated into storybook reading with an emphasis on psychoeducation, relaxation techniques, social skills, graded exposure and cognitive strategies, for preschool children

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Coping Skills - Coping Questionnaire Parent Report
Time Frame: Close out (Weeks 9 to 10)
This consists of questions with a likert type response ranging from a minimum of 1 to a maximum of 7, measuring parent's perception of their child's coping efficacy in anxiety-inducing situations, which they nominate. In this study, the Coping Questionnaire is modified to have 4 questions, each pre-defined to be in keeping with each the four audiobook's anxiety-inducing situations. A higher score indicates a better outcome.
Close out (Weeks 9 to 10)
Coping Skills - Coping Skills Word Definitions
Time Frame: Close out (Weeks 9 to 10)
This consists of 8 emotional target words that are repeated throughout the 4 audiobooks. Each word is linked to common elements of CBT which are found in each of the four audiobooks, these include relaxation in book 1, social skills in book 2, graded exposure in book 3, cognitive techniques in book 4 and psychoeducation across all 4 books. Each word is scored as 0,1 or 2 denoting incorrect, partially correct and correct. Higher scores denote a better outcome.
Close out (Weeks 9 to 10)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coping skills - Personal Story Generation
Time Frame: Close-out (Weeks 9 to 10)
Children are asked to verbally tell two personal stories, based on the first and the last books of the audiobooks in the cognitive behavioural arm. Higher scores denote better outcomes.
Close-out (Weeks 9 to 10)
Anxiety- Preschool Anxiety Scale
Time Frame: Close out (Weeks 9 to 10)
This measures the presence and severity of children's overall anxiety and six subtypes of anxiety: generalised anxiety, obsessive-compulsive disorder, physical injury fears, social anxiety, and separation anxiety. This has 28 items, with each item's minimum value of 0 and a maximum of 4. A higher score denotes a worse outcome.
Close out (Weeks 9 to 10)
Maladjustment - Paediatric Symptom Checklist-17
Time Frame: Close out (Weeks 9 to 10)
This is a 17-question parental report screen on children's internalising, attention and externalising problems, with a never/sometimes/often type response, designed for use in children age 4-15 years old. A higher score denotes a worse outcome.
Close out (Weeks 9 to 10)
Maladjustment - Children's Emotional Adjustment Scale
Time Frame: Close out (Weeks 9 to 10)
This has 29 questions with a never/seldom/sometimes/often/always response (ranging from 0 to 4), measuring children's emotional function in the domains of temper control, social assertiveness, and anxiety control. A higher score denotes a better outcome.
Close out (Weeks 9 to 10)
Social Emotional Learning - Social Skills Improvement System
Time Frame: Close out (Weeks 9 to 10)
This has 51 questions and measures children's social emotional learning in the domains of self-awareness, self-management, social awareness, relationship skills and responsible decision-making, with a never/seldom/sometimes/often/always response. Individual item scores range from 0 to 4 with a higher score denoting a better outcome.
Close out (Weeks 9 to 10)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility and Acceptability Objective : AIM, IAM and FIM
Time Frame: Close out (Weeks 9 to 10)
Parents will also be asked to evaluate the acceptability and feasibility of the CB preventative programme, through a 12-item questionnaire. The questionnaire will consist of items in the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) subscales. Each item's response is completely disagree/disagree/neither agree nor disagree/agree/completely agree. Each item is scored as a minimum of 1 and maximum of 5, with higher scores denoting better outcomes.
Close out (Weeks 9 to 10)
Feasibility and Acceptability Objective : Fidelity Questionnaire
Time Frame: Post Randomisation (Weeks 3 to 8)
Four questions after each session are asked on the scale of none/less than half/more than half/all. These pertain to the extent to which the pages were turned, audio was played, questions were asked and activities completed. Each question is scored from a minimum of 0 to a maximum of 3, with higher scores denoting better outcomes.
Post Randomisation (Weeks 3 to 8)
Feasibility and Acceptability Objective : Usable data
Time Frame: Baseline (Weeks 1 to 2 ) and Closeout (Weeks 9 to 10 )
The amount of usable data at baseline and post test will be monitored
Baseline (Weeks 1 to 2 ) and Closeout (Weeks 9 to 10 )
Feasibility and Acceptability Objective : Attrition
Time Frame: Basline (Weeks 1 to 2) and Post-randomisation (Weeks 3 to 8) and Closeout (Weeks 9 to 10)
The number of participants who withdraw from the study will be monitored
Basline (Weeks 1 to 2) and Post-randomisation (Weeks 3 to 8) and Closeout (Weeks 9 to 10)
Feasibility and Acceptability Objective : Enrollment of Participants
Time Frame: Enrollment
The number of participants across the span of the enrollment period of the study will be measured.
Enrollment
Language Arm Outcome : Proximal Word Definitions
Time Frame: Close-out (Weeks 9 to 10)
Consists of 8 items, where children are asked to verbally define words that are elaborated in the language arm. Each word is scored as 0,1 or 2 denoting incorrect, partially correct and correct. Higher scores denote a better outcome.
Close-out (Weeks 9 to 10)
Language Arm Outcome : Proximal Narrative Structures
Time Frame: Close-out (Weeks 9 to 10)
Children are asked to verbally tell two personal stories, based on the first and the last books of the audiobooks in the language arm. Higher scores denote better outcomes.
Close-out (Weeks 9 to 10)
Language Arm Outcome : Narrative Structures
Time Frame: Close-out (Weeks 9 to 10)
To re-tell a story with pictures, and answer comprehension questions, from the Multilingual Assessment Instrument for Narratives (MAIN). Higher scores denote better outcomes.
Close-out (Weeks 9 to 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanyang Technological University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG130/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Some examples of IPD are those collected in the outcomes tab. IDP from this study can be accessed for future research beyond this trial, only after approval from the NTU IRB Board is obtained, and only for participants who have indicated on this consent form that they agree for their data to be used for future research.

IPD Sharing Access Criteria

NTU and NIE researchers will be able to access the IPD. The study manual/protocol and will be shared on the NIE research data repository (https://researchdata.nie.edu.sg/). MPEG, WAVE, MS Word, SPSS (.sav and .por), comma-separated values, tab-delimited, and MS Excel files will be shared. SPSS, Mplus, Microsoft Excel, Microsoft Word, Media Player, R, and ideally Nvivo will be needed to read the files. The sharing of NTU-owned research data such as the IPD of this study is based on Creative Commons license CC:BY:NC, where others may reuse the data for noncommercial applications only and must correctly attribute the data source in NTU.

Supporting information such as study protocol is being prepared for publication, and can be accessed once published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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