Understanding of Psychotic Disorders in Children With 22q11.2DS

Not Applicable

Recruiting

• Conditions: 22q11.2 Deletion Syndrome
• Interventions: Behavioral: neuropsychological testing, questionnaires and experimental tasks

• Registration Number: NCT04639388
• Lead Sponsor: Hôpital le Vinatier

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.

Study Timeline

• Study First Submitted: 2020-10-01
• Study Start: 2020-11-13
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14
• Primary Completion: 2024-10-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
22q11.2DS	neuropsychological testing, questionnaires and experimental tasks	Children aged from 4 to 13 years old with 22q11.2 deletion syndrome
Control Group (Non22q11.2DS)	neuropsychological testing, questionnaires and experimental tasks	Children aged from 4 to 13 years old without developmental disease

Primary Outcome Measures

Name	Time	Method
The Screen for child Anxiety Related Emotional Disorders (SCARED)	Day 1	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	Day 1	Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition

Secondary Outcome Measures

Name	Time	Method
Rey's Tangled Lines Test	Day 1	Proportion of impaired scaled score to study the degree of cognitive development in children
Sustained hearing attention test (Tea-Ch battery)	Day 1	Proportion of impaired scaled score at the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch)
NEPSY II battery	Day 1	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	Day 1	Mean reaction time in neuropsychological testing and experimental tasks

Trial Locations

Locations (1)

Hopital Vinatier; 🇫🇷 Lyon, Rhone Alpes, France