Clinical trial NCT03284060: Social Cognition Training and Cognitive Remediation
Official title: Social Cognition Training and Cognitive Remediation : a New Tool for 22q11.2 Deletion Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 22q11.2 Deletion Syndrome
Keywords: Cognitive remediation, 22q11.2 deletion syndrome
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 3
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open Label
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children with diagnosis of 22q11.2 deletion syndrome (CGH-Array and FISH)
* Native French speaker
* Clinically stable
* Parental and children consent

Exclusion Criteria:

* history of neurological illness or trauma
* Taking of medicine with somatic aim having a cerebral or psychic impact
* Simultaneous participation on another program of cognitive remediation
* child or parents unlikely to cooperate

Primary outcomes:
measure: The primary endpoint is the variation in sub-scores of specific baselines, obtained before and after cognitive remediation intervention:
timeFrame: 6 months
Secondary outcomes:
measure: Aberrant Behavior Checklist scale
timeFrame: 6 months
measure: MDI-C scale ( Multiscore Depression Inventory for Children scale)
timeFrame: 6 months
measure: KIDSCREEN-27 scale
timeFrame: 6 months
measure: Vineland 2 scale (Vineland Adaptive Behavior Scale)
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Vinatier
state: Rhone Alpes
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: DEMILY CAROLINE, PH
role: PRINCIPAL_INVESTIGATOR
References: