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Social Cognition Training and Cognitive Remediation (RCKID)

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ClinicalTrials.gov Identifier: NCT03284060
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Tracking Information
First Submitted Date  ICMJE September 13, 2017
First Posted Date  ICMJE September 15, 2017
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE October 11, 2017
Estimated Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
The primary endpoint is the variation in sub-scores of specific baselines, obtained before and after cognitive remediation intervention: [ Time Frame: 6 months ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03284060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2017)
  • Aberrant Behavior Checklist scale [ Time Frame: 6 months ]
    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.
  • MDI-C scale ( Multiscore Depression Inventory for Children scale) [ Time Frame: 6 months ]
  • KIDSCREEN-27 scale [ Time Frame: 6 months ]
    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).
  • Vineland 2 scale (Vineland Adaptive Behavior Scale) [ Time Frame: 6 months ]
    A measure of adaptive behavior from birth to adulthood
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Social Cognition Training and Cognitive Remediation
Official Title  ICMJE Social Cognition Training and Cognitive Remediation : a New Tool for 22q11.2 Deletion Syndrome
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
open Label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE 22q11.2 Deletion Syndrome
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: Cognitive remediation program
Intervention: Behavioral: Cognitive remediation program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2020
Estimated Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: DEMILY CAROLINE, PH 00334 37 91 51 63 caroline.demily@ch-le-vinatier.fr
Contact: MOREL Aurore 00334 37 91 51 63 aurore.morel@ch-le-vinatier.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03284060
Other Study ID Numbers  ICMJE 2017-A00881-52
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hôpital le Vinatier
Study Sponsor  ICMJE Hôpital le Vinatier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: DEMILY CAROLINE, PH CENTRE HOSPITALIER LE VINATIER
PRS Account Hôpital le Vinatier
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP