NCT07425951

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
4mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

February 13, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

February 13, 2026

Last Update Submit

April 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (5)

  • Coping skills - Personal Story Generation

    Close-out (Weeks 9 to 10)

  • Anxiety- Preschool Anxiety Scale

    Close out (Weeks 9 to 10)

  • Maladjustment - Paediatric Symptom Checklist-17

    Close out (Weeks 9 to 10)

  • Maladjustment - Children's Emotional Adjustment Scale

    Close out (Weeks 9 to 10)

  • Social Emotional Learning - Social Skills Improvement System

    Close out (Weeks 9 to 10)

Other Outcomes (8)

  • Feasibility and Acceptability Objective : AIM, IAM and FIM

    Close out (Weeks 9 to 10)

  • Feasibility and Acceptability Objective : Fidelity Questionnaire

    Post Randomisation (Weeks 3 to 8)

  • Feasibility and Acceptability Objective : Usable data

    Baseline (Weeks 1 to 2 ) and Closeout (Weeks 9 to 10 )

  • +5 more other outcomes

Study Arms (2)

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.

Device: Language

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.

Device: Cognitive Behavioural

Interventions

Cognitive behavioural therapy incorporated into storybook reading with an emphasis on psychoeducation, relaxation techniques, social skills, graded exposure and cognitive strategies, for preschool children

CB-arm
LanguageDEVICE

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

LANG-arm

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Education, Nanyang Technological University

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Shaun Goh, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer/Research Scientist

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 23, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Access Criteria
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.

Locations