Social Cognition Training and Cognitive Remediation (RCKID)

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.

Study Overview

• Status: Terminated
• Conditions: 22q11.2 Deletion Syndrome
• Intervention / Treatment: Behavioral: Cognitive remediation program

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhone Alpes
    • Lyon, Rhone Alpes, France, 69678
      • Hopital Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Cognitive remediation program

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: pen and paper tasks focusing on specific emotion recognition component (20 min),; computerized tasks focusing on the same process (20 min),; a proposal of a home-based task (during 20 min).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months
Vineland 2 scale (Vineland Adaptive Behavior Scale)	A measure of adaptive behavior from birth to adulthood	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.	6 months
MDI-C scale ( Multiscore Depression Inventory for Children scale)		6 months

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: DEMILY CAROLINE, PH, Centre Hospitalier Le Vinatier

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2017
• Primary Completion (ACTUAL): March 9, 2018
• Study Completion (ACTUAL): May 21, 2019

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (ACTUAL): September 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Cognitive remediation, 22q11.2 deletion syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Lymphatic Diseases; Endocrine System Diseases; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Musculoskeletal Diseases; Parathyroid Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Abnormalities, Multiple; Chromosome Disorders; 22q11 Deletion Syndrome; Lymphatic Abnormalities; Hypoparathyroidism; Syndrome; DiGeorge Syndrome
• Other Study ID Numbers: 2017-A00881-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No