Social Cognition Training and Cognitive Remediation

NCT03284060 | Terminated

• 1 other identifier: 2017-A00881-52
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

22q11.2 Deletion Syndrome

Keywords

Cognitive remediation, 22q11.2 deletion syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Aberrant Behavior Checklist scale

  6 months

• MDI-C scale ( Multiscore Depression Inventory for Children scale)

  6 months

• KIDSCREEN-27 scale

  6 months

• Vineland 2 scale (Vineland Adaptive Behavior Scale)

  6 months

Study Arms (1)

Cognitive remediation program

EXPERIMENTAL

Behavioral: Cognitive remediation program

Interventions

Cognitive remediation program BEHAVIORAL

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).

Cognitive remediation program

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

DiGeorge Syndrome

Condition Hierarchy (Ancestors)

22q11 Deletion Syndrome; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Lymphatic Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Hypoparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• DEMILY CAROLINE, PH

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open Label

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: October 11, 2017
• Primary Completion: March 9, 2018
• Study Completion: May 21, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)