Understanding of Psychotic Disorders in Children With 22q11.2DS
PremiCeS22
Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old
1 other identifier
interventional
80
1 country
1
Brief Summary
The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 1, 2020
CompletedStudy Start
First participant enrolled
November 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
July 30, 2025
July 1, 2025
5.6 years
October 1, 2020
July 29, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
The Screen for child Anxiety Related Emotional Disorders (SCARED)
Scale assessing behavioral prodromes or warning signs of hallucinations in psychotic disorders A psychometric study is then carried out on this questionnaire in order to validate it with parents of children carrying 22q11.2DS.
Day 1
facial expression recognition task
Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition
Day 1
Secondary Outcomes (4)
Sustained hearing attention test (Tea-Ch battery)
Day 1
Rey's Tangled Lines Test
Day 1
NEPSY II battery
Day 1
Mean reaction time
Day 1
Study Arms (2)
22q11.2DS
EXPERIMENTALChildren aged from 4 to 13 years old with 22q11.2 deletion syndrome
Control Group (Non22q11.2DS)
ACTIVE COMPARATORChildren aged from 4 to 13 years old without developmental disease
Interventions
Neuropsychological testing (the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch); the Overlapping lines task of Rey; auditory attention of NEPSY II battery); questionnaires completed by the children's legal representatives to assess behavior; experimental tasks evaluating gaze direction and facial expression recognition
Eligibility Criteria
You may qualify if:
- Diagnosis of 22q11.2 deletion syndrome or no developmental disease
- Aged from 4 to 13 years old
- French language
You may not qualify if:
- Diagnosis of intellectual deficiency according to DSM 5 criteria
- Drug prescribed for somatic condition that could influence cerebral functioning
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Vinatier
Lyon, Auvergne-Rhône-Alpes, 69678, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-Noëlle BABINET
CH LE VINATIER
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2020
First Posted
November 20, 2020
Study Start
November 13, 2020
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share