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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LANG-arm | Active Comparator | 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. |
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| CB-arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural | Device | Cognitive behavioural therapy incorporated into storybook reading with an emphasis on psychoeducation, relaxation techniques, social skills, graded exposure and cognitive strategies, for preschool children |
| Measure | Description | Time Frame |
|---|---|---|
| Coping Skills - Coping Questionnaire Parent Report | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Coping skills - Personal Story Generation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Acceptability Objective : AIM, IAM and FIM | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaun Goh, PhD | Contact | 62196250 | shaun.goh@nie.edu.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Education, Nanyang Technological University | Recruiting | Singapore | Singapore |
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.
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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.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Language | Device | Storybook reading with an emphasis on specific word vocabulary and narrative structure serving as a control, for preschool children |
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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 | 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 | 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 | 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) |
| Close out (Weeks 9 to 10) |
| Feasibility and Acceptability Objective : Fidelity Questionnaire | 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 | 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 | 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 | The number of participants across the span of the enrollment period of the study will be measured. | Enrollment |
| Language Arm Outcome : Proximal Word Definitions | 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 | 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 | 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) |