About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Cognitive Behavioural
DeviceCognitive behavioural therapy incorporated into storybook reading with an emphasis on psychoeducation, relaxation techniques, social skills, graded exposure and cognitive strategies, for preschool children
Language
DeviceStorybook reading with an emphasis on specific word vocabulary and narrative structure serving as a control, for preschool children
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
Anxiety- Preschool Anxiety Scale
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.
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.
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.
Other outcomes
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.
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.
Feasibility and Acceptability Objective : Usable data
The amount of usable data at baseline and post test will be monitored
Feasibility and Acceptability Objective : Attrition
The number of participants who withdraw from the study will be monitored
Sponsors and contacts
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