National Institute of Education, Nanyang Technological University
Singapore
Location status: Recruiting
NCT Number: NCT07425951
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.
Interested in participating?
Request Info4 year–6 year
All sexes
Interventional
Not applicable
Singapore
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive behavioural therapy incorporated into storybook reading with an emphasis on psychoeducation, relaxation techniques, social skills, graded exposure and cognitive strategies, for preschool children
Storybook reading with an emphasis on specific word vocabulary and narrative structure serving as a control, for preschool children
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Post Randomisation (Weeks 3 to 8)
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: Baseline (Weeks 1 to 2 ) and Closeout (Weeks 9 to 10 )
The amount of usable data at baseline and post test will be monitored
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
Time frame: Enrollment
The number of participants across the span of the enrollment period of the study will be measured.
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.
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.
Time frame: Close-out (Weeks 9 to 10)
To re-tell a story with pictures, and answer comprehension questions, from the Multilingual Assessment Instrument for Narratives (MAIN). Higher scores denote better outcomes.
Contact information is provided by the study sponsor or research team.
Nanyang Technological University
Other
Acronym: B-READY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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