Understanding of Psychotic Disorders in Children With 22q11.2DS (PremiCeS22)
Primary Purpose
22q11.2 Deletion Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
neuropsychological testing, questionnaires and experimental tasks
Sponsored by
About this trial
This is an interventional basic science trial for 22q11.2 Deletion Syndrome
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of 22q11.2 deletion syndrome or no developmental disease
- Aged from 4 to 13 years old
- French language
Exclusion Criteria:
- Diagnosis of intellectual deficiency according to DSM 5 criteria
- Drug prescribed for somatic condition that could influence cerebral functioning
Sites / Locations
- Hopital VinatierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
22q11.2DS
Control Group (Non22q11.2DS)
Arm Description
Children aged from 4 to 13 years old with 22q11.2 deletion syndrome
Children aged from 4 to 13 years old without developmental disease
Outcomes
Primary Outcome Measures
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.
facial expression recognition task
Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition
Secondary Outcome Measures
Sustained hearing attention test (Tea-Ch battery)
Proportion of impaired scaled score at the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch)
Rey's Tangled Lines Test
Proportion of impaired scaled score to study the degree of cognitive development in children
NEPSY II battery
Proportion of impaired scaled score at auditory attention of NEPSY II battery The NEPSY-II is a comprehensive neuropsychological battery for children ages 3-12. The test provides measures of sensor-motor, language, visuospatial processing, memory and learning, attention/executive functions, and social cognition.
Mean reaction time
Mean reaction time in neuropsychological testing and experimental tasks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04639388
Brief Title
Understanding of Psychotic Disorders in Children With 22q11.2DS
Acronym
PremiCeS22
Official Title
Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome
Detailed Description
22q11.2DS is one of the most common microdeletion syndromes (1 / 2000-1 / 4000 births) and one of the most robust genetic risk factors for schizophrenia (1 to 2% of cases). Reciprocally, approximately 30% of patients with 22q11.2DS will develop psychotic symptoms in adolescence or early adulthood. It is now well established that children and adults with 22q11.2DS have lower social skills than developing youth. These social dysfunctions could be partly underpinned by alterations in social cognitive processes, and could also be linked to the emergence of psychotic signs or even schizophrenia. However, to our knowledge, no study has investigated the existence of behavioral prodromal signs during the onset of psychotic signs in children with 22q11.2DS. In addition, the origin of social cognitive processes remains to this day little explored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
22q11.2 Deletion Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric study with two parallel groups
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
22q11.2DS
Arm Type
Experimental
Arm Description
Children aged from 4 to 13 years old with 22q11.2 deletion syndrome
Arm Title
Control Group (Non22q11.2DS)
Arm Type
Active Comparator
Arm Description
Children aged from 4 to 13 years old without developmental disease
Intervention Type
Behavioral
Intervention Name(s)
neuropsychological testing, questionnaires and experimental tasks
Intervention Description
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
Primary Outcome Measure Information:
Title
The Screen for child Anxiety Related Emotional Disorders (SCARED)
Description
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.
Time Frame
Day 1
Title
facial expression recognition task
Description
Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Sustained hearing attention test (Tea-Ch battery)
Description
Proportion of impaired scaled score at the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch)
Time Frame
Day 1
Title
Rey's Tangled Lines Test
Description
Proportion of impaired scaled score to study the degree of cognitive development in children
Time Frame
Day 1
Title
NEPSY II battery
Description
Proportion of impaired scaled score at auditory attention of NEPSY II battery The NEPSY-II is a comprehensive neuropsychological battery for children ages 3-12. The test provides measures of sensor-motor, language, visuospatial processing, memory and learning, attention/executive functions, and social cognition.
Time Frame
Day 1
Title
Mean reaction time
Description
Mean reaction time in neuropsychological testing and experimental tasks
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of 22q11.2 deletion syndrome or no developmental disease
Aged from 4 to 13 years old
French language
Exclusion Criteria:
Diagnosis of intellectual deficiency according to DSM 5 criteria
Drug prescribed for somatic condition that could influence cerebral functioning
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline DEMILY, MD PH
Phone
0450915163
Ext
+33
Email
caroline.demily@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique VIAL
Phone
0437915531
Ext
+33
Email
veronique.vial@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Noëlle BABINET
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Vinatier
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DEMILY MD CAROLINE, PH
Phone
0033437915163
Email
caroline.demily@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
VIAL VERONIQUE
Phone
0033437915531
Email
veronique.vial@ch-le-vinatier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Understanding of Psychotic Disorders in Children With 22q11.2DS
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