Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-04 @ 12:46 AM
Study NCT ID:
NCT05901558
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2023-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Communication and Symbolic Behavior Scales Developmental Profile（CSBS）', 'timeFrame': 'from enrollment (T0) to 1 year(T2)', 'description': 'The Checklist consists of 24 questions that range from 2 to 4 points within each of 7 Clusters, including language predictors: emotion and eye gaze, communication, gestures, sounds, words, understanding, and object use. Give credit of 0 points for items checked Not Yet, 1 point for items checked Sometimes, or 2 points for items checked Often. 7 Cluster scores will be summed to yield three Composite scores (including expressive speech, symbolic and communication) and a total score. The change of each score for T0, T1 and T2 will be measured.'}], 'secondaryOutcomes': [{'measure': 'Autism Diagnostic Observation Schedule-Second edition(ADOS-2)', 'timeFrame': 'from enrollment (T0) to 1 year(T2)', 'description': 'Autism Diagnostic Observation Schedule-Second edition(ADOS-2):\n\nThe results from the social affect(SA) and restricted and repetitive behavior (RRB, subdomains were added together to generate the total raw score. The total raw score was converted into the ADOS calibrated severity score , ranging from 1 to 10, with 10 being the most severe.'}, {'measure': 'Parenting Stress Index/Short Form （PSI/SF）', 'timeFrame': 'from enrollment (T0) 1 year(T2)', 'description': '3 sub-scales, including parent distress (PD), parent-child dysfunctional interaction(PCDI), difficult child (DC). This scale assesses stress in parents.'}, {'measure': 'The Griffiths Mental Development Scales (GMDS)', 'timeFrame': 'from enrollment (T0) 1 year(T2)', 'description': 'GMDS includes six subscales:\n\nLocomotor (Lm), Personal and Social (P/S), Hearing and Speech (H/Sp), Eye and Hand (E/Hd), Performance (Pf) and Practical Reasoning (Pr). The raw scores were transformed into developmental quotients (DQ) using the standard method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism', 'Naturalistic developmental behavioral intervetion', 'Intervention'], 'conditions': ['Autism Spectrum Disorder', 'Therapy']}, 'descriptionModule': {'briefSummary': "The project aims to develop and implement the Strategies for Toddler Autism spectrum disorder(ASD) with Remote-therapy (STAR) model for early toddlers with ASD in local community sites in Shanghai. It's a randomized control trial lasting 3 years. The children will be divided into 2 groups, one for STAR intervention group and the other for community intervention group. The STAR intervention group will be performed STAR other than community intervention.", 'detailedDescription': "Autism spectrum disorder (ASD) brings enormous economic and emotional burdens to families and society with its ever-increasing prevalence. Early intervention has been proved as the key treatment to ASD. Along with increasing number of ASD children identified and diagnosed at early stage, the needs for effective early intervention are dramatically increasing. Though therapist-delivered intensive programs for toddlers yield substantive developmental gains, they tend to be costly and with extremely limited resource. The lockdowns during the COVID-19 pandemic brings even more obstacles for the children and families to get access to the resource of intervention. As such, the traditional intervention models are not fit for wide implementation within the Chinese public health systems and pandemic situation.\n\nTo solve this dilemma, this project aims to develop and implement the Strategies for Toddler ASD with Remote-therapy (STAR) model for early toddlers with ASD in local community sites in Shanghai. To maximize the intervention effect, the intervention strategies in STAR model are designed under the Naturalistic Developmental Behavioral Intervention (NDBI) framework which are implemented in natural settings targeting at improving social and communicational capabilities. The structure of the STAR model is with 2 modules and 16 sessions. Module I derives from our previous offline parent-tutoring courses with 8 intervention strategy topics combining academic instruction and real child demonstration but modified into on-line version. Module II is designed specifically for long-term consolidation of parents' intervention skills containing 8 biweekly sessions of distance coaching with parents practicing intervention with their children in real time at home."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Months', 'minimumAge': '16 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children screened as positive for ASD.\n* Two-tiered screening process combing Level 1(The Modified Checklist for Autism in Toddlers-Revised/Follow-Up , M-CHAT-R/F) and Level 2 (The Screening Tool for Autism in Toddlers and Young Children, STAT)\n\nExclusion Criteria:\n\n* Other neurologic or degenerative diseases;\n* Severe hearing or visual impairment;\n* Genetic anomaly which may affect impact on intervention;\n* Not available for regular intervention and follow-up.'}, 'identificationModule': {'nctId': 'NCT05901558', 'briefTitle': 'Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Strategies for Toddler ASD With Remote-therapy (STAR) Model for Early ASD Toddlers: a Randomized Trial', 'orgStudyIdInfo': {'id': 'STAR-ASD 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STAR intervention group', 'description': "The intervention strategies in STAR model are designed under the Naturalistic Developmental Behavioral Intervention (NDBI) framework which are implemented in natural settings targeting at improving social and communicational capabilities. The structure of the STAR model is with 2 modules and 16 sessions. Module I derives from our previous offline parent-tutoring courses with 8 intervention strategy topics combining academic instruction and real child demonstration but modified into on-line version. Module II is designed specifically for long-term consolidation of parents' intervention skills containing 8 biweekly sessions of distance coaching with parents practicing intervention with their children in real time at home.", 'interventionNames': ['Behavioral: Strategies for Toddler ASD with Remote-therapy (STAR)']}, {'type': 'OTHER', 'label': 'community intervention group', 'description': 'This group will have community interventions parents can choose.', 'interventionNames': ['Behavioral: Community intervention']}], 'interventions': [{'name': 'Strategies for Toddler ASD with Remote-therapy (STAR)', 'type': 'BEHAVIORAL', 'description': 'The intervention strategies in STAR model are designed under the Naturalistic Developmental Behavioral Intervention (NDBI) framework which are implemented in natural settings targeting at improving social and communicational capabilities', 'armGroupLabels': ['STAR intervention group']}, {'name': 'Community intervention', 'type': 'BEHAVIORAL', 'description': 'Regular community intervention', 'armGroupLabels': ['community intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiong Xu, PhD', 'role': 'CONTACT', 'email': 'stellaxuqiong@hotmail.com'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qiong Xu, PhD', 'role': 'CONTACT', 'email': 'xuqiong@fuda.edu.cn', 'phone': '02164931275'}, {'name': 'Chunchun Hu, MD', 'role': 'CONTACT', 'email': '14211240007@fudan.edu.cn', 'phone': '15721445658'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}