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Clinical Trials/NCT04639388
NCT04639388RecruitingNot Applicable

Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old

Hôpital le Vinatier2 sites in 1 country80 target enrollmentStarted: November 13, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
80
Locations
2
Primary Endpoint
The Screen for child Anxiety Related Emotional Disorders (SCARED)

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
4 Years to 13 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

The Screen for child Anxiety Related Emotional Disorders (SCARED)

Time Frame: 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

Time Frame: Day 1

Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition

Secondary Outcomes

  • Rey's Tangled Lines Test(Day 1)
  • Sustained hearing attention test (Tea-Ch battery)(Day 1)
  • NEPSY II battery(Day 1)
  • Mean reaction time(Day 1)

Investigators

Sponsor
Hôpital le Vinatier
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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