- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07425951
Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years (B-READY)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shaun Goh, PhD
- Phone Number: 62196250
- Email: shaun.goh@nie.edu.sg
Study Locations
-
-
-
Singapore, Singapore
- Recruiting
- National Institute of Education, Nanyang Technological University
-
Contact:
- Shaun Goh, PhD
- Phone Number: +6562196250
- Email: shaun.goh@nie.edu.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
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)
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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.
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Post Randomisation (Weeks 3 to 8)
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Feasibility and Acceptability Objective : Usable data
Time Frame: Baseline (Weeks 1 to 2 ) and Closeout (Weeks 9 to 10 )
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The amount of usable data at baseline and post test will be monitored
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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
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Basline (Weeks 1 to 2) and Post-randomisation (Weeks 3 to 8) and Closeout (Weeks 9 to 10)
|
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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.
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Close-out (Weeks 9 to 10)
|
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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)
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG130/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
Studies a U.S. FDA-regulated device product
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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