Improving Self-regulation in Children With Neurodevelopmental Disorders:
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|ClinicalTrials.gov Identifier: NCT04418921|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2020
Last Update Posted : May 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Child Behavior Disorders ASD ADHD||Behavioral: Self-regulation: MRehab - Un colegio emocionante, clinical trial with non-immersive virtual reality Behavioral: Traditional self-regulation program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Self-Regulation in Children With Neurodevelopmental Disorders "SR-MRehab: Un Colegio Emocionante": a Protocol Study With Virtual Reality|
|Estimated Study Start Date :||October 2022|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Experimental Group
Intervention on self-regulation will be carried out through a non-immersive virtual reality platform, "SR-Mrehab: Un colegio emocionante" in which students must conduct a series of activities designed specifically for this purpose. These activities will be performed by the children using mainly their hands to manage the virtual objects showed in the screen. To do this, our system make use of a Kinect motion sensor connected to the computer to control the body movements of the children. Moreover, our system records some relevant data of the execution of these activities for further analysis of the children's performance.The exercises will be divided into two blocks, emotional regulation (ER) and cognitive regulation (CR), in a total of 10 sessions, once a week, performing an exercise of each block per session. Each session will consists of 60 minutes. .
Behavioral: Self-regulation: MRehab - Un colegio emocionante, clinical trial with non-immersive virtual reality
The principles of the programme will be based on the following premises for children with ASD: 1) Strengthening communicative attempts; 2) Choose the most natural contexts possible; 3) Establish structured and predictable routines and environments; 4)Visually support information; 5) Adapting our language to the understanding level of the child. On the difficulty of interpreting and responding to social emotions and cues, games of perspectives are of great interest, where the child and therapist describe the same object from different perspectives, beliefs (guess that may be in this box), games with social stories, which are short stories that use pictograms, to help understand especially situations with social ambiguity: 1) describing what happens; 2) orienting the action, indicating to the child what to do in that situation; 3) anticipating and explaining what can happen and how you can feel; 4) developing a strategy that can be applied in similar situations.
Active Comparator: Control group
The children from control group will follow a program of emotional education of Primary Schools, though group activities in the classroom (5, 49). Each session will last 50 minutes, just like in the experimental group. The content of the sessions will include 5 sessions of emotional awareness and 5 sessions of emotional and cognitive regulation. The activities are similar for the experimental group, but the virtual reality system will not be used. It will be held in parallel in another room of the school, on the same day and time, carried out by occupational therapists and students from the students in the last year of occupational therapy degree.
Behavioral: Traditional self-regulation program
The children from control group will follow a program of emotional education of Primary Schools, though group activities in the classroom .The content of the sessions will include 5 sessions of emotional awareness and 5 sessions of emotional and cognitive regulation.Each session will last 50 minutes
Other Name: Educative programa
- Emotional Perception [ Time Frame: 6 months ]Change in the number of errors in the recognition of recognized emotions on faces in the Affect Recognition subtest of the Children's Neuropsychology Assessment Battery (NEPSY-II), whose minimum scores are "0" and the maximum number of errors for children older than 6 years: 79. The higher the score, the worse the recognition of emotions.
- Emotional Regulation [ Time Frame: 6 months ]Change in the ability to understand mental functions, such as belief, intention, deceit, to understand the relationship between emotions and the social context, according to the Theory of Mind subtest of the Children's Neuropsychology Assessment Battery (NEPSY-II), whose minimum scores is "0" and the maximum score is 28. The higher the score, the better the ability to mentalize and recognize the mental states of other people.
- Cognitive Flexibility [ Time Frame: 6 monhs ]Change in the skills of maintaining attention and for the ability to change and maintain a new pattern of responses, according to the Auditory attention and cognitive flexibility subtest of the Children's Neuropsychology Assessment Battery (NEPSY-II), whose minimum score is "0" and the maximum score is 30. The higher the score, the number of correct answers, the better the ability to attend and to be flexible with changes. In addition, it allows knowing the number of errors, divided into three types: commission, omission and inhibition errors. The greater the number of errors, the worse the attention and cognitive flexibility. The minimum error score is "0" and the maximum number of commission errors is 189, the maximum number of omission errors are 39, and the maximum number of inhibition errors is 33.
- Planning, Sequencing [ Time Frame: 6 months ]Change in planning and organization skills, as well as in self-supervision capacity, according to the Children's Neuropsychology Assessment Battery Clocks subtest (NEPSY-II), whose minimum scores are "0" and the maximum score is 78. A higher Score best ability to plan, sequence and monitor the action.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418921
|Contact: Dulce Romero Ayusofirstname.lastname@example.org|