NCT07283458

Brief Summary

Language is central to children's cognitive, emotional, and social development, and language difficulties are a frequent reason for consultation in child psychiatry, often co-occurring with psychiatric disorders. Yet, systematic language assessment is rarely possible due to the limited availability of speech-language therapists in these services. The TICOALA tool (Interactive Test of Language Comprehension and Learning on tablet) offers a quick and engaging way to evaluate lexical and syntactic comprehension and word learning. This study aims to assess its acceptability among children aged 3-7 attending a child psychiatry service in Paris, as well as among clinicians and parents. Secondary goals include testing the feasibility of a larger study, describing children's language skills, and examining how these relate to clinical and background variables.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Jan 2026Mar 2028

First Submitted

Initial submission to the registry

November 20, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

January 3, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2028

Last Updated

December 19, 2025

Status Verified

October 1, 2025

Enrollment Period

2.2 years

First QC Date

November 20, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

language assessment

Outcome Measures

Primary Outcomes (1)

  • Acceptability of the TICOALA tool among children attending our child psychiatry service

    This objective will be evaluated using a questionnaire with a 5-point Likert scale, with a composite evaluation criterion based on three elements: the child's opinion, their level of attention, and their level of motivation. The questionnaire will be completed by the consultant, reporting the child's opinion and their clinical observations (attention, motivation) during the assessment.

    4 months

Study Arms (1)

Children with language comprehension and learning difficulties

OTHER
Other: TICOALA

Interventions

TICOALAOTHER

The TICOALA tool (Interactive Test of Language Comprehension and Learning on tablet) offers a quick and engaging way to evaluate children's lexical and syntactic comprehension, as well as their ability to learn new words. Integrating this tool into clinical practice could provide an initial language assessment and help guide referrals for formal speech-language evaluation.

Children with language comprehension and learning difficulties

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children (boys or girls) aged 3-7 years
  • Consulting in the child psychiatry service
  • Enrolled in a French-speaking school

You may not qualify if:

  • Inability to use the tablet-based TICOALA tool due to severe sensory (blindness, deafness), motor, or intellectual impairment
  • Refusal of the child or parents/legal guardians to participate
  • Child not affiliated with the French social security system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 15, 2025

Study Start

January 3, 2026

Primary Completion (Estimated)

March 3, 2028

Study Completion (Estimated)

March 3, 2028

Last Updated

December 19, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Only anonimyzed results will be shared. Each child will be assigned a code. Data shared will simply include scores on the tasks and answers in the questionnaires without any information linked to each individual identity.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE