Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorNanyang Technological University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

  • Language

    Device

    Storybook reading with an emphasis on specific word vocabulary and narrative structure serving as a control, for preschool children

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: LANG-armActive comparator 1 intervention
Group B: CB-armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Close out (Weeks 9 to 10)
2

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.

Time frame
Close out (Weeks 9 to 10)

Secondary outcomes

1

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.

Time frame
Close-out (Weeks 9 to 10)
2

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.

Time frame
Close out (Weeks 9 to 10)
3

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.

Time frame
Close out (Weeks 9 to 10)
4

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.

Time frame
Close out (Weeks 9 to 10)

Other outcomes

1

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.

Time frame
Close out (Weeks 9 to 10)
2

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.

Time frame
Post Randomisation (Weeks 3 to 8)
3

Feasibility and Acceptability Objective : Usable data

The amount of usable data at baseline and post test will be monitored

Time frame
Baseline (Weeks 1 to 2 ) and Closeout (Weeks 9 to 10 )
4

Feasibility and Acceptability Objective : Attrition

The number of participants who withdraw from the study will be monitored

Time frame
Basline (Weeks 1 to 2) and Post-randomisation (Weeks 3 to 8) and Closeout (Weeks 9 to 10)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.