Health TrialsbyHealthPanel

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

Condition22q11.2 Deletion Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-13
SponsorHôpital le Vinatier

About this trial

The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis of 22q11.2 deletion syndrome or no developmental disease

Aged from 4 to 13 years old

French language

Disqualifiers

Diagnosis of intellectual deficiency according to DSM 5 criteria

Drug prescribed for somatic condition that could influence cerebral functioning

Trial design

Design model

Parallel

Treatments tested in this trial

  • neuropsychological testing, questionnaires and experimental tasks

    Behavioral

    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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: 22q11.2DSExperimental treatment 1 intervention
Group B: Control Group (Non22q11.2DS)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1
2

facial expression recognition task

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

Time frame
Day 1

Secondary outcomes

1

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)

Time frame
Day 1
2

Rey's Tangled Lines Test

Proportion of impaired scaled score to study the degree of cognitive development in children

Time frame
Day 1
3

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.

Time frame
Day 1
4

Mean reaction time

Mean reaction time in neuropsychological testing and experimental tasks

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hôpital le Vinatier

Lead sponsor

Source ClinicalTrials.gov
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