22q11.2 Deletion Syndrome Clinical Trial
Official title:
Social Cognition Training and Cognitive Remediation : a New Tool for 22q11.2 Deletion Syndrome
Social cognition refers to mental operations that enable people to perceive, interpret
constantly changing social informations. These processes allow people to rapidly,
effortlessly and flexibly perceive and interpret rapidly-changing social information, and
respond appropriately to social stimuli. Besides, this ability gives meaning to the actions
of others. Impairments in this field may largely underlie social dysfunctions and reduce
adaptive skills. Moreover, social cognitive disabilities contribute more or less directly to
behavioral disturbances and psychiatric symptoms The "RC KID" program involves a variety of
exercises in a paper and/or pencil or a computerized format or role playing and a strategy
coaching approach. "RC KID" targets the emotion recognition and social interaction.
A little cartoon character (a pirate), is supposed to be very friendly and kind toward
children. The pirate will accompany them throughout the program for an effective and positive
reinforcement. The main goal of "RC KID" is to adjust to children's difficulties in daily
life.
Moreover, since the cognitive remediation benefit is complex to apply in daily life, the
program is based on a metacognitive strategy.
After a complete neuropsychological assessment and a psychoeducational session (with the
child and the parents), 16 1-h-sessions of cognitive remediation with the therapist are
proposed. Each session is composed of three parts: (1) computerized tasks focusing on
specific emotion recognition components (20 min). RC KID is composed of 2 modules : Emotion
recognition and social interaction. These tasks contain photo or video. (2) pen and paper or
role playing tasks focusing on the same processes (20 min) (3) a proposal of a home-based
task (during 20 min). Weekly, home tasks are proposed to the child and analyzed with the
parents and the therapist. Indeed, home exercises are useful to promote the transfer of
strategies to daily life and their subsequent automation. The heterogeneity of cognitive
deficits in 22q11.2 deletion necessitates an individualized cognitive remediation therapy. In
this regard, "RC KID" seems to be a promising tool.
The second objective is to evaluate the impact of RC KID on behavior disorders. Method : a
validation study using multiple single-case experimental designs. A thorough assessment,
including a complete evaluation of components of social cognition but also clinical and
neuropsychological assessments is proposed for each patient enrolled in the study.
Investigators collect three kinds of baselines before the beginning of the cognitive
remediation intervention: baselines specific of the targeted component (Emotion recognition
and Theory of Mind), non-specific baselines (such as measures of neurocognition processes
that should not be affected by the intervention), and intermediary baselines that is measures
of social cognitive function linked with targeted processes but not directly concerned by the
cognitive remediation program.
These measures and the complete assessment will be repeated at the end of the intervention to
highlight impacts of RC KID on social cognitive impairments, and 6 months later to
investigate the possible long-lasting effects of the benefits.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04639960 -
Neuroprotective Effects of Risperdal on Brain and Cognition in 22q11 Deletion Syndrome
|
N/A | |
Recruiting |
NCT04373226 -
Arithmetic Abilities in Children With 22q11.2DS
|
N/A | |
Completed |
NCT01781923 -
Cognitive Remediation in 22q11DS
|
N/A | |
Completed |
NCT02895906 -
Safety and Efficacy Study of NFC-1 in Subjects Aged 12-17 Years With 22q11.2DS & Associated Neuropsychiatric Conditions
|
Phase 1 | |
Recruiting |
NCT04639388 -
Understanding of Psychotic Disorders in Children With 22q11.2DS
|
N/A | |
Completed |
NCT00916955 -
Genetic Modifiers for 22q11.2 Syndrome
|
||
Recruiting |
NCT05924347 -
Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development
|
||
Recruiting |
NCT00556530 -
Examining Genetic Factors That Affect the Severity of 22q11.2 Deletion Syndrome
|
||
Completed |
NCT02460328 -
Resolution of Primary Immune Defect in 22q11.2 Deletion Syndrome
|
N/A | |
Completed |
NCT04647500 -
Effects of Methylphenidate on Brain and Cognition in 22q11 Deletion Syndrome
|
N/A |