Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Self-regulation in Children With Neurodevelopmental Disorders:

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418921
Recruitment Status : Not yet recruiting
First Posted : June 5, 2020
Last Update Posted : May 17, 2022
Sponsor:
Collaborator:
University of Castilla-La Mancha
Information provided by (Responsible Party):
Dulce Romero Ayuso, Universidad de Granada

Brief Summary:
Children with neurodevelopmental disorders may show difficulties in self-regulation. The main objective of this study is to improve self-regulation skills in children between 6 and 11 years old with neurodevelopmental disorders. Methodology: A randomized controlled trial will be conducted with the use of "SF-MRehab: Un colegio emocionante", a non-inmersive virtual reality system where virtual objects can be managed by children in a natural way by using their hands. Children will be recruited from several schools from Granada (Spain) and they will be randomly allocated to two groups. Assessment will be conducted before and after the intervention as well as 24 weeks after the end of the intervention process. Experimental group will receive the intervention using virtual reality. Control group will receive the intervention through a standard self-regulation program. Both interventions will be performed once a week for a total of 10 sessions. Changes in self-regulation, as well as acceptability of technology with the use of SR-MRehab will be evaluated. The results will be published and will contribute with evidence regarding the use of this type of intervention on children with neurodevelopmental disorders

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical Diagnosis of Autism Spectrum Disorders and / or Attention Deficit Disorder with Hyperactivity
  • Have special educational needs;
  • Oral comprehension, with the possibility of fixing the gaze;
  • Be able to attend to verbal and visual instructions;
  • Be able to maintain sustained attention for at least four minutes.

Exclusion Criteria:

  • Severe motor disability;
  • Children with major behavioural problems, such as self-harm;
  • Children with high abilities.

Initially, all students of this center with special educational needs will be invited.


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Dulce Romero Ayuso +34626822916 dulceromero@ugr.es

Sponsors and Collaborators
Universidad de Granada
University of Castilla-La Mancha
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dulce Romero Ayuso, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04418921    
Other Study ID Numbers: SR-MRehab
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders
Neurodevelopmental Disorders
Child Behavior Disorders