Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:24 AM
Study NCT ID:
NCT07425951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Feasibility and Acceptability Objective : AIM, IAM and FIM', 'timeFrame': 'Close out (Weeks 9 to 10)', 'description': "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."}, {'measure': 'Feasibility and Acceptability Objective : Fidelity Questionnaire', 'timeFrame': 'Post Randomisation (Weeks 3 to 8)', 'description': '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.'}, {'measure': 'Feasibility and Acceptability Objective : Usable data', 'timeFrame': 'Baseline (Weeks 1 to 2 ) and Closeout (Weeks 9 to 10 )', 'description': 'The amount of usable data at baseline and post test will be monitored'}, {'measure': 'Feasibility and Acceptability Objective : Attrition', 'timeFrame': 'Basline (Weeks 1 to 2) and Post-randomisation (Weeks 3 to 8) and Closeout (Weeks 9 to 10)', 'description': 'The number of participants who withdraw from the study will be monitored'}, {'measure': 'Feasibility and Acceptability Objective : Enrollment of Participants', 'timeFrame': 'Enrollment', 'description': 'The number of participants across the span of the enrollment period of the study will be measured.'}, {'measure': 'Language Arm Outcome : Proximal Word Definitions', 'timeFrame': 'Close-out (Weeks 9 to 10)', 'description': '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.'}, {'measure': 'Language Arm Outcome : Proximal Narrative Structures', 'timeFrame': 'Close-out (Weeks 9 to 10)', 'description': '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.'}, {'measure': 'Language Arm Outcome : Narrative Structures', 'timeFrame': 'Close-out (Weeks 9 to 10)', 'description': 'To re-tell a story with pictures, and answer comprehension questions, from the Multilingual Assessment Instrument for Narratives (MAIN). Higher scores denote better outcomes.'}], 'primaryOutcomes': [{'measure': 'Coping Skills - Coping Questionnaire Parent Report', 'timeFrame': 'Close out (Weeks 9 to 10)', 'description': "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."}, {'measure': 'Coping Skills - Coping Skills Word Definitions', 'timeFrame': 'Close out (Weeks 9 to 10)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Coping skills - Personal Story Generation', 'timeFrame': 'Close-out (Weeks 9 to 10)', 'description': '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.'}, {'measure': 'Anxiety- Preschool Anxiety Scale', 'timeFrame': 'Close out (Weeks 9 to 10)', 'description': "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."}, {'measure': 'Maladjustment - Paediatric Symptom Checklist-17', 'timeFrame': 'Close out (Weeks 9 to 10)', 'description': "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."}, {'measure': "Maladjustment - Children's Emotional Adjustment Scale", 'timeFrame': 'Close out (Weeks 9 to 10)', 'description': "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."}, {'measure': 'Social Emotional Learning - Social Skills Improvement System', 'timeFrame': 'Close out (Weeks 9 to 10)', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Coping Skills', 'Socio-emotional Well-being']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Currently be enrolled in K1 or K2 in preschool.\n* Singaporean Citizen or of Permanent Resident status\n* Parent of study's participant has to have read a book with participant at least once in the last 6 months.\n\nExclusion Criteria:\n\n* Not currently enrolled in a child support programme\n* Not currently receiving medication for mental health concerns\n* Not currently receiving support from a Speech Language Therapist or Psychologist."}, 'identificationModule': {'nctId': 'NCT07425951', 'acronym': 'B-READY', 'briefTitle': 'Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years', 'organization': {'class': 'OTHER', 'fullName': 'Nanyang Technological University'}, 'officialTitle': 'Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years', 'orgStudyIdInfo': {'id': 'RG130/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LANG-arm', 'description': '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 10 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.', 'interventionNames': ['Device: Language']}, {'type': 'EXPERIMENTAL', 'label': 'CB-arm', 'description': "The CB-arm consists of 4 storybooks with accompanying audioplayer. These are provided to parents of participants to complete with their child. As shown in Table 1, each storybook focuses on one cognitive behavioural strategy, namely relaxation, social skills, exposure and cognitive techniques. Each CBT element is linked to two words for a total of 10 target words, which are repeated across the storybooks. Each storybook follows a 'problem-feeling-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.", 'interventionNames': ['Device: Cognitive Behavioural']}], 'interventions': [{'name': 'Cognitive Behavioural', 'type': 'DEVICE', 'description': 'Cognitive behavioural therapy incorporated into storybook reading with an emphasis on psychoeducation, relaxation techniques, social skills, graded exposure and cognitive strategies, for preschool children', 'armGroupLabels': ['CB-arm']}, {'name': 'Language', 'type': 'DEVICE', 'description': 'Storybook reading with an emphasis on specific word vocabulary and narrative structure serving as a control, for preschool children', 'armGroupLabels': ['LANG-arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'contacts': [{'name': 'Shaun Goh, PhD', 'role': 'CONTACT', 'email': 'shaun.goh@nie.edu.sg', 'phone': '+6562196250'}], 'facility': 'National Institute of Education, Nanyang Technological University', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Shaun Goh, PhD', 'role': 'CONTACT', 'email': 'shaun.goh@nie.edu.sg', 'phone': '62196250'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', '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.', 'accessCriteria': '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.\n\nSupporting information such as study protocol is being prepared for publication, and can be accessed once published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanyang Technological University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer/Research Scientist', 'investigatorFullName': 'Shaun Goh Kok Yew', 'investigatorAffiliation': 'Nanyang Technological University'}}}}