Typical DevelopmentTICOALA-SOINSNCT07283458
Assessment of Language Comprehension and Learning in Children Attending Child Psychiatry Services (TICOALA-SOINS)
A study testing TICOALA in people with Typical Development and Typically Developing Children Ages 3 to 6, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Typical Development, Typically Developing Children Ages 3 to 6, Typical Preschoolers Who Can Not Zipper
- What is being tested?
- TICOALA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2026to 19 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children (boys or girls) aged 3-7 years
- Consulting in the child psychiatry service
- Enrolled in a French-speaking school
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Barabara BONNEL
Paris, 75014
Barabara BONNEL, barbara.bonnel@ghu-paris.fr
Maryse LEVY-RUEFF, Dr, M.LEVY-RUEFF@ghu-paris.fr
About this study
Official title: TICOALA-SOINS : Assessment of Language Comprehension and Learning in Children Attending Child Psychiatry Services. Pilot Study of Acceptability and Feasibility.
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.
Read the detailed description
Language is intrinsically linked to children's cognitive, social, emotional, and psychological development, and plays a crucial role in both academic achievement and psychosocial adjustment. In child psychiatry, language difficulties are a common reason for consultation and are frequently associated with psychiatric conditions such as anxiety disorders or attention difficulties. However, due to the limited availability of speech-language therapists in these settings, systematic language assessments are rarely conducted.
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.
Main Objective To assess the acceptability of the TICOALA tool among children attending our child psychiatry service.
Secondary Objectives
- To evaluate its acceptability for clinicians (psychiatrists, psychologists) and parents.
- To assess the acceptability of the parental clinical questionnaire.
- To determine the feasibility of conducting a larger-scale study.
- To describe the language skills (lexical, syntactic, word learning) of children in our service.
- To analyze the relationship between language skills and clinical/anamnestic data (socio-economic background, play and screen exposure, language experience, etc.).
Target Population Children aged 3-7 years consulting at the child psychiatry service in the 14th arrondissement of Paris.
- Conditions
- Typical Development, Typically Developing Children Ages 3 to 6, Typical Preschoolers Who Can Not Zipper, Children, Children Behavior Problem, FRENCH STUDY
- Being tested
- TICOALA
- Keywords
- language assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with language comprehension and learning difficulties | Other | Not described Receives: Other: TICOALA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start19 Mar 2026
- Primary completion19 Mar 2028 (estimated)
- Study completion19 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typical DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Université Paris Cité, Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283458
- Sponsor's protocol ID
- D25-P001
- Acronym
- TICOALA-SOINS
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TICOALA-SOINS : Assessment of Language Comprehension and Learning in Children Attending Child Psychiatry Services. Pilot Study of Acceptability and Feasibility.
- ClinicalTrials.gov ID
- NCT07283458
- Acronym / sponsor ID
- TICOALA-SOINS / D25-P001
- Conditions
- Typical Development, Typically Developing Children Ages 3 to 6, Typical Preschoolers Who Can Not Zipper, Children, Children Behavior Problem, FRENCH STUDY
- Keywords
- language assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Université Paris Cité, Centre National de la Recherche Scientifique, France
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 19 Mar 2028 (estimated)
- Study completion
- 19 Mar 2028 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Language is intrinsically linked to children's cognitive, social, emotional, and psychological development, and plays a crucial role in both academic achievement and psychosocial adjustment. In child psychiatry, language difficulties are a common reason for consultation and are frequently associated with psychiatric conditions such as anxiety disorders or attention difficulties. However, due to the limited availability of speech-language therapists in these settings, systematic language assessments are rarely conducted.
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.
Main Objective To assess the acceptability of the TICOALA tool among children attending our child psychiatry service.
Secondary Objectives
- To evaluate its acceptability for clinicians (psychiatrists, psychologists) and parents.
- To assess the acceptability of the parental clinical questionnaire.
- To determine the feasibility of conducting a larger-scale study.
- To describe the language skills (lexical, syntactic, word learning) of children in our service.
- To analyze the relationship between language skills and clinical/anamnestic data (socio-economic background, play and screen exposure, language experience, etc.).
Target Population Children aged 3-7 years consulting at the child psychiatry service in the 14th arrondissement of Paris.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with language comprehension and learning difficulties | Other | Other: TICOALA |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children (boys or girls) aged 3-7 years
- Consulting in the child psychiatry service
- Enrolled in a French-speaking school
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TICOALAThe 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. | Other | Children with language comprehension and learning difficulties |
Primary outcome
Acceptability of the TICOALA tool among children attending our child psychiatry service
Time frame: 4 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TICOALA in people with Typical Development and Typically Developing Children Ages 3 to 6, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaoussou SYLLA, Dr (+33145658486, K.SYLLA@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the TICOALA tool among children attending our child psychiatry service (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.