Improving Self-regulation in Children With Neurodevelopmental Disorders:

NCT04418921 | Unknown

• 1 other identifier: SR-MRehab
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Conditions

Child Behavior Disorders; ASD; ADHD

Outcome Measures

Primary Outcomes (2)

• Emotional Perception

  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.

  6 months

• Emotional Regulation

  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.

  6 months

Secondary Outcomes (2)

• Cognitive Flexibility

  6 monhs

• Planning, Sequencing

  6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Self-regulation: MRehab - Un colegio emocionante, clinical trial with non-immersive virtual reality BEHAVIORAL

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.

Experimental Group

Traditional self-regulation program BEHAVIORAL

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

Also known as: Educative programa

Control group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• University of Castilla-La Mancha: collaborator

Related Publications (11)

• Alcaniz ML, Olmos-Raya E, Abad L. [Use of virtual reality for neurodevelopmental disorders. A review of the state of the art and future agenda]. Medicina (B Aires). 2019;79(Suppl 1):77-81. Spanish.

  PMID: 30776285 BACKGROUND

• Bashiri A, Ghazisaeedi M, Shahmoradi L. The opportunities of virtual reality in the rehabilitation of children with attention deficit hyperactivity disorder: a literature review. Korean J Pediatr. 2017 Nov;60(11):337-343. doi: 10.3345/kjp.2017.60.11.337. Epub 2017 Nov 27.

  PMID: 29234356 BACKGROUND

• Parsons TD, Riva G, Parsons S, Mantovani F, Newbutt N, Lin L, Venturini E, Hall T. Virtual Reality in Pediatric Psychology. Pediatrics. 2017 Nov;140(Suppl 2):S86-S91. doi: 10.1542/peds.2016-1758I.

  PMID: 29093039 BACKGROUND

• Eom H, Kim KK, Lee S, Hong YJ, Heo J, Kim JJ, Kim E. Development of Virtual Reality Continuous Performance Test Utilizing Social Cues for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. Cyberpsychol Behav Soc Netw. 2019 Mar;22(3):198-204. doi: 10.1089/cyber.2018.0377. Epub 2019 Jan 23.

  PMID: 30672714 BACKGROUND

• Bekele E, Zheng Z, Swanson A, Crittendon J, Warren Z, Sarkar N. Understanding how adolescents with autism respond to facial expressions in virtual reality environments. IEEE Trans Vis Comput Graph. 2013 Apr;19(4):711-20. doi: 10.1109/TVCG.2013.42.

  PMID: 23428456 RESULT

• Voss C, Schwartz J, Daniels J, Kline A, Haber N, Washington P, Tariq Q, Robinson TN, Desai M, Phillips JM, Feinstein C, Winograd T, Wall DP. Effect of Wearable Digital Intervention for Improving Socialization in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Pediatr. 2019 May 1;173(5):446-454. doi: 10.1001/jamapediatrics.2019.0285.

  PMID: 30907929 RESULT

• Bekele E, Crittendon J, Zheng Z, Swanson A, Weitlauf A, Warren Z, Sarkar N. Assessing the utility of a virtual environment for enhancing facial affect recognition in adolescents with autism. J Autism Dev Disord. 2014 Jul;44(7):1641-50. doi: 10.1007/s10803-014-2035-8.

  PMID: 24419871 RESULT

• Yuan SNV, Ip HHS. Using virtual reality to train emotional and social skills in children with autism spectrum disorder. London J Prim Care (Abingdon). 2018 Jun 7;10(4):110-112. doi: 10.1080/17571472.2018.1483000. eCollection 2018.

  PMID: 30083244 RESULT

• Shema-Shiratzky S, Brozgol M, Cornejo-Thumm P, Geva-Dayan K, Rotstein M, Leitner Y, Hausdorff JM, Mirelman A. Virtual reality training to enhance behavior and cognitive function among children with attention-deficit/hyperactivity disorder: brief report. Dev Neurorehabil. 2019 Aug;22(6):431-436. doi: 10.1080/17518423.2018.1476602. Epub 2018 May 17.

  PMID: 29771624 RESULT

• Blume F, Hudak J, Dresler T, Ehlis AC, Kuhnhausen J, Renner TJ, Gawrilow C. NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2017 Jan 24;18(1):41. doi: 10.1186/s13063-016-1769-3.

  PMID: 28118856 RESULT

• Romero-Ayuso D, Alcantara-Vazquez P, Almenara-Garcia A, Nunez-Camarero I, Trivino-Juarez JM, Ariza-Vega P, Molina JP, Gonzalez P. Self-Regulation in Children with Neurodevelopmental Disorders "SR-MRehab: Un Colegio Emocionante": A Protocol Study. Int J Environ Res Public Health. 2020 Jun 12;17(12):4198. doi: 10.3390/ijerph17124198.

  PMID: 32545534 DERIVED

MeSH Terms

Conditions

Child Behavior Disorders; Attention Deficit Disorder with Hyperactivity

Interventions

Clinical Trials as Topic

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Intervention Hierarchy (Ancestors)

Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Dulce Romero Ayuso

CONTACT

+34626822916; dulceromero@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 5, 2020
• Study Start: October 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share