Recrutement en cours

VRAMVirtual Reality Attention Management Program for Improving Attention in Children

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Ce qui est testé

VR Treatment

+ VR Active Control

Dispositif médical
Qui peut participer

De 8 à 12 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : juin 2016
Voir le détail du protocole

Résumé

Sponsor principalUniversity of California, Davis
Contacts de l'étudeJuan RamosVoir plus de contacts
Dernière mise à jour : 13 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Date de début de l'étude : 2 juin 2016

Date à laquelle le premier participant a commencé l'étude.

Distraction is a growing and large public health problem with estimated societal harm due to distracted driving alone at $123 billion. In the age of texting, social media and computer pop-ups, distractions are unavoidable. There are no known interventions specifically developed to reduce distractions from interfering with attention. This project will test a treatment that combines virtual reality (VR) technology with habituation learning and exposure therapy to reduce the ability of distractors to interfere with learning and attention in children who are highly susceptible to being distracted. The investigators will test the treatment in children with symptoms of attention-deficit/hyperactivity disorder (ADHD) as they represent an enriched sample experiencing impairing distractibility that interferes with their daily functioning. The investigators hypothesize that children who suffer from severe distractibility can learn to ignore the distractors and improve their attention in VR therapy that simulates environments requiring focused attention. The neural targets of the therapy are both proactive and reactive control mechanisms used to suppress distractor processing. The investigators will assess how well VR therapy is at modulating distractor suppression via saccade metrics and measure the frequency of oculomotor capture by distractors as well as the efficiency of distractor suppression before and after therapy. Changes in head movement toward distractors, parent and teacher ADHD rating scales and improved performance on attention-demanding tasks will further assess success of the therapy and its ability to generalize to novel environments. Children will practice computer exercises at home using a VR headset that simulates a classroom environment with a high rate of distractors. Children will be performing attention-demanding tasks as if they were in a classroom with the intensity and rate of presentation of the personalized distractions (e.g., peers talking, teacher walking by) adapted according to the child's performance. With today's low-cost VR-gaming technology, children will be able to participate in habituation treatment sessions at-home, several times a week, using a lightweight and comfortable VR gaming headset. In this "fast fail" test of the VR therapy, the project will assess the preliminary success and feasibility of VR training to modify saccades to distractors in an adaptive training versus nonadaptive training scenario. Data from this trial will determine whether to go forward for a subsequent confirmatory study.

Titre officielVirtual Reality Attention Management Program for Improving Attention in Children 
NCT03221244
Sponsor principalUniversity of California, Davis
Contacts de l'étudeJuan RamosVoir plus de contacts
Dernière mise à jour : 13 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

50 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 8 à 12 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Critères

Inclusion Criteria: * Significant (T score \>= 60) ratings of Cognitive Problems/Inattention or DSM Inattention scale scores on the Conners' Parent or Teacher Rating Scale-3 or Parent ADHD Rating Scale-IV (ADHD-RS) * Endorsement of 4 or more symptoms of inattention on a clinical psychiatric interview (e.g. Parent DISC, DICA, Kiddie-SADS, Mini-KID) * Comfortable using a computer * Full Scale IQ \> 80 Exclusion Criteria: * Psychosis (by parent report at phone screen), significant depression, autism (15 or \> on Social Communication Questionnaire (SCQ)), psychotic disorders, visual or hearing impairment or any other disorder that may interfere with task performance * It is in the investigator's opinion that it is not in the subject's best interest to continue * Subject is non-compliant with training schedule * Subjects on pharmacotherapy for ADHD at the time of enrollment will be excluded from Aims 3 and 4. * Subjects starting behavioral or psychological treatment for ADHD during the training phase of the study will be excluded

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
The "VR distractor condition" is an adaptive training, experimental treatment. Participants will wear a headset VR system programmed to simulate a virtual classroom. They will be asked to perform computer tests of math, attention, or working memory in the virtual reality context. Distractors will be presented intermittently throughout the test session. During training sessions, distractor saliency and frequency will increase or decrease based on performance on the tests. 25 sessions should be completed in approximately 5-7 weeks. In-home VR training sessions will each be about 20-30 minutes in length. The investigators expect a decrease in distraction after adaptive distractor exposure in the VR classroom.

Groupe II

Comparateur actif
The "VR classroom with no distractors presented" is an active control group. This group will undergo the same training regimen, only their virtual classroom environment will not contain adaptive distractors. Participants will wear a headset VR system programmed to simulate a virtual classroom. They will be asked to perform computer tests of math, attention, or working memory in the virtual reality context. 25 sessions should be completed in approximately 5-7 weeks. In-home VR training sessions will each be about 20-30 minutes in length. The investigators expect no change in response to distraction in the ADHD group after control exposure to the VR classroom.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Recrutement en cours

UC Davis MIND Institute

Sacramento, United StatesVoir le site
Recrutement en cours
1 Centres d'Étude