An interventional study of Cognitive remediation program in 22q11.2 Deletion Syndrome, sponsored by Hôpital le Vinatier. Terminated at 1 site in France. Open to participants aged 5 Years to 13 Years. Per ClinicalTrials.gov, last updated 2020-01-09.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Treatment
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.
47 studies on the registry are indexed under DiGeorge Syndrome; 11 are open to participants now.
This study's enrollment of 3 is below the median of 26 across 27 interventional studies indexed under DiGeorge Syndrome.
Browse DiGeorge Syndrome studies →Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Behavioral: Cognitive remediation program
Cognitive remediation program is a set of reeducation techniques and aims at restoring or compensating altered cognitive functions such as memory, attentional or executive functions, and social cognition. Therapists help individuals develop new information processing strategies designed to meet their needs and wishes. Specific therapeutic sessions are designed to generalize such strategies to everyday situations to reduce the impact of cognitive deficits on daily life. Thus, social cognitive training therapy helps the development of personal strategies specifically adapted to preserve skills and reduce the difficulties. 16 sessions (45 min) of cognitive remediation with the therapist are proposed, each session is composed of three parts: 1. pen and paper tasks focusing on specific emotion recognition component (20 min), 2. computerized tasks focusing on the same process (20 min), 3. a proposal of a home-based task (during 20 min).
The primary endpoint is the variation in sub-scores of specific baselines, obtained before and after 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), intermediary baselines that is measures of social cognitive function linked with targeted processes but not directly concerned by the cognitive remediation program. These measure is repeated at the end of the intervention to highlight the impact of the " RCKID " program, and 6 months later to investigate the possible long-lasting effects of the benefits
Time frame: 6 months
Aberrant Behavior Checklist scale
Change in sub-score " hyperactivity / non compliance " (scale " Aberrant Behavior Checklist ") (completed by parents or the educational team). This measure is repeated at the end of the intervention to highlight the impact of the " RC KID " program, and 6 months later to investigate the possible long-lasting effects of the benefits.
Time frame: 6 months
MDI-C scale ( Multiscore Depression Inventory for Children scale)
Time frame: 6 months
KIDSCREEN-27 scale
The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy \& Parents (7 items), Peers \& Social Support (4 items), and School Environment (4 items).
Time frame: 6 months
Vineland 2 scale (Vineland Adaptive Behavior Scale)
A measure of adaptive behavior from birth to adulthood
Time frame: 6 months
Plan to share: No
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Ran from Oct 2017 to primary completion in Mar 2018, 4 months.
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This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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