Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:20 PM
Study NCT ID:
NCT07426302
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leiter-3', 'timeFrame': 'T0(baseline)-T1(6months)', 'description': 'The Leiter-3 is a nonverbal, standardized cognitive assessment tool designed to evaluate intellectual functioning, attention, and memory in children and adolescents. In this study, selected subtests from the Leiter-3 will be used not only to estimate nonverbal IQ, but also to assess attentional control and memory capacity at both baseline and post-intervention. Administering the Leiter-3 at T0 and T1 allows for the comparison of pre- and post-intervention cognitive functioning without the confounding effects of language. Scaled scores from the Reasoning, Attention/Memory, and Processing Speed subdomains will be analyzed.'}, {'measure': 'Tower of London', 'timeFrame': 'T0(baseline)-T1(6months)', 'description': 'The Tower of London (ToL) is a standardized neuropsychological test used to assess higher-order executive functions, particularly planning, problem-solving, and working memory.'}, {'measure': 'NEPSY-II', 'timeFrame': 'T0(baseline)-T1(6months)', 'description': 'Subtests from the NEPSY-II (e.g., Auditory Attention and Response Set, Inhibition) will be administered to evaluate selective attention, sustained attention, cognitive flexibility, and the ability to shift between task demands. These measures are developmentally appropriate and widely used to detect attentional and executive control difficulties in children and adolescents with neurodevelopmental conditions.'}], 'secondaryOutcomes': [{'measure': 'Conners Rating Scales', 'timeFrame': 'T0(baseline)-T1(6months)', 'description': 'The Conners Rating Scales are validated questionnaires completed by caregivers and/or teachers to assess symptoms of inattention, hyperactivity, and impulsivity, as well as related behavioral concerns.'}, {'measure': 'Child Behavior Checklist (CBCL)', 'timeFrame': 'T0(baseline)-T1(6months)', 'description': 'The CBCL is a caregiver-completed behavioral inventory used to identify emotional and behavioral problems in children. It includes internalizing and externalizing behavior subscales and is a standardized tool for tracking psychological and behavioral changes over time in children with ASD and ADHD. T-scores will be used for analysis.'}, {'measure': 'Short Sensory Profile (SSP)', 'timeFrame': 'T0(baseline)-T1(6months)', 'description': 'The SSP is a caregiver-reported tool used to identify atypical sensory processing patterns in children. It provides scores on several sensory domains such as tactile sensitivity, sensory seeking, and auditory filtering. This instrument is widely used to describe sensory modulation issues in neurodivergent children and track potential improvements following therapeutic interventions.'}, {'measure': 'Repetitive Behavior Scale-Revised (RBS-R)', 'timeFrame': 'T0(baseline)-T1(6months)', 'description': 'The RBS-R is a caregiver-reported measure of repetitive and restricted behaviors, including stereotypies, compulsions, insistence on sameness, and ritualistic behaviors. It is frequently used in research on autism to quantify behavioral rigidity and repetitive actions. Total and subscale scores will be analyzed to determine the impact of the intervention on these behaviors.'}, {'measure': 'Quality of Life in Autism Questionnaire (QoLA)', 'timeFrame': 'T0(baseline)-T1(6months)', 'description': 'The Quality of Life in Autism Questionnaire (QoLA) is a validated caregiver-report instrument designed to assess autism-specific quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD - Attention Deficit Disorder With Hyperactivity', 'Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '30569407', 'type': 'BACKGROUND', 'citation': 'Yerys BE, Bertollo JR, Kenworthy L, Dawson G, Marco EJ, Schultz RT, Sikich L. Brief Report: Pilot Study of a Novel Interactive Digital Treatment to Improve Cognitive Control in Children with Autism Spectrum Disorder and Co-occurring ADHD Symptoms. J Autism Dev Disord. 2019 Apr;49(4):1727-1737. doi: 10.1007/s10803-018-3856-7.'}, {'pmid': '18166120', 'type': 'BACKGROUND', 'citation': 'Patel K, Curtis LT. A comprehensive approach to treating autism and attention-deficit hyperactivity disorder: a prepilot study. J Altern Complement Med. 2007 Dec;13(10):1091-7. doi: 10.1089/acm.2007.0611.'}, {'pmid': '37616029', 'type': 'BACKGROUND', 'citation': 'Chu L, Shen L, Ma C, Chen J, Tian Y, Zhang C, Gong Z, Li M, Wang C, Pan L, Zhu P, Wu D, Wang Y, Yu G. Effects of a Nonwearable Digital Therapeutic Intervention on Preschoolers With Autism Spectrum Disorder in China: Open-Label Randomized Controlled Trial. J Med Internet Res. 2023 Aug 24;25:e45836. doi: 10.2196/45836.'}, {'pmid': '37522637', 'type': 'BACKGROUND', 'citation': "Chan JK, Cheung TC, Chan CW, Fang F, Lai KY, Sun X, O'Reilly H, Golan O, Allison C, Baron-Cohen S, Leung PW. Enhancing emotion recognition in young autistic children with or without attention-deficit/hyperactivity disorder in Hong Kong using a Chinese App version of The Transporters. Autism. 2024 Apr;28(4):945-958. doi: 10.1177/13623613231187176. Epub 2023 Jul 31."}, {'pmid': '40507763', 'type': 'BACKGROUND', 'citation': 'De Domenico C, Alito A, Leonardi G, Pironti E, Di Cara M, Piccolo A, Settimo C, Quartarone A, Gagliano A, Cucinotta F. Children and Adolescents with Co-Occurring Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder: A Systematic Review of Multimodal Interventions. J Clin Med. 2025 Jun 5;14(11):4000. doi: 10.3390/jcm14114000.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of a virtual reality-based intervention using the Virtual Reality Rehabilitation System (VRRS) to improve executive functions in autistic and ADHD youth aged 8 to 18 years. Executive functions, such as working memory, cognitive flexibility, and inhibitory control, are frequently impaired in individuals with autism and/or ADHD and significantly affect daily functioning. Participants will be randomly assigned to either an experimental group that receives VRRS-assisted cognitive training or a control group that receives treatment as usual. The intervention includes gamified tasks within immersive virtual environments specifically designed to stimulate executive skills. The primary outcome is the change in executive function scores from baseline to post-intervention, assessed using validated neuropsychological instruments. The study adopts a randomized controlled design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 8 and 18 years at enrollment\n* Clinical diagnosis of Autism Spectrum Disorder and Attention- Deficit/Hyperactivity Disorder, based on DSM-5 criteria\n* IQ \\> 70\n* Signed Informed consent provided by a parent or legal guardian;\n* No acute or chronic medical conditions\n\nExclusion Criteria:\n\n* Age not between 8 and 18 years at enrollment\n* Lack of a clinical diagnosis of Autism Spectrum Disorder or Attention-Deficit/Hyperactivity Disorder\n* IQ \\< 70\n* Failure to sign informed consent from a parent or legal guardian;\n* Presence of acute or chronic medical conditions'}, 'identificationModule': {'nctId': 'NCT07426302', 'briefTitle': 'Virtual Reality-assisted Cognitive Rehabilitation in Autistic Youth With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Centro Neurolesi Bonino Pulejo'}, 'officialTitle': 'A Randomized Controlled Trial on the Effectiveness of Virtual Reality-assisted Executive Function Training in Autistic and ADHD Youth', 'orgStudyIdInfo': {'id': 'VRRS_PLUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VRRS Cognitive Training', 'description': "The intervention consists of 20 individual sessions using the Virtual Reality Rehabilitation System (VRRS). Each session lasts 45 minutes and is held biweekly. The project aims to stimulate and improve memory and executive functions, such as planning and attention, in children with ASD and ADHD. The VRRS platform integrates semi-immersive and interactive cognitive exercises in a virtual environment, increasing engagement and motivation. Tasks are progressively adapted to the participant's level and performance.", 'interventionNames': ['Behavioral: VRRS Cognitive Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment As Usual', 'description': 'Participants in this group will begin traditional CBT intervention without the use of virtual reality technology.', 'interventionNames': ['Behavioral: Treatment as Usual (TAU)']}], 'interventions': [{'name': 'VRRS Cognitive Training', 'type': 'BEHAVIORAL', 'description': 'VRRS is a virtual reality system designed to offer interactive cognitive exercises in an immersive environment. Participants will complete 20 sessions (one session per week). Each session lasts approx', 'armGroupLabels': ['VRRS Cognitive Training']}, {'name': 'Treatment as Usual (TAU)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive the usual care typically provided in clinical or educational settings, such as attention training, memory exercises, or academic support. The frequency and duration of sessions will be comparable to the experimental group, but without the use of VR technology.', 'armGroupLabels': ['Treatment As Usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Messina', 'country': 'Italy', 'facility': 'Francesca Cucinotta', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'overallOfficials': [{'name': 'Cucinotta Francesca, CF', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Neurolesi Bonino Pulejo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Centro Neurolesi Bonino Pulejo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}