Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 2:50 AM
Study NCT ID:
NCT05284435
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'C562465', 'term': 'Phobia, Specific'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010698', 'term': 'Phobic Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-item Pediatric Anxiety Rating Scale - Autism Spectrum Disorder', 'timeFrame': '7 days', 'description': 'Clinician rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.'}, {'measure': 'Clinical Global Impression-Improvement', 'timeFrame': '7 days', 'description': 'Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).'}], 'secondaryOutcomes': [{'measure': 'Revised Child Anxiety and Depression Scale- Parent-Report- Anxiety Subscale', 'timeFrame': '7 days', 'description': 'Parent rated child anxiety severity. It is a 37-item scale and each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 to 111.'}, {'measure': 'Revised Child Anxiety and Depression Scale- Self-Report- Anxiety Subscale', 'timeFrame': '7 days', 'description': 'Child rated anxiety severity. It is a 37-item scale and each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 to 111.'}, {'measure': 'Social Responsiveness Scale, Second Edition', 'timeFrame': '7 days', 'description': 'Parent rated child impairment in social behaviors. It is a 65-item scale and each item is scored on a 1 ("not true") to 4 ("almost always true") scale (higher scores correspond to greater impairment), yielding a total raw score between 65 and 260.'}, {'measure': 'Sheehan Disability Scale', 'timeFrame': '7 days', 'description': 'Parent rated child functional impairment. It is a 5-item scale and each item is scored on a 0 ("not at all") to 10 ("extremely") scale (higher scores correspond to greater impairment), yielding a total between 0 and 50.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Behavioral Therapy', 'Autism Spectrum Disorder', 'Anxiety Disorder', 'Obsessive-Compulsive Disorder', 'Social Anxiety Disorder', 'Generalized Anxiety Disorder', 'Specific Phobia']}, 'referencesModule': {'references': [{'pmid': '39368459', 'type': 'DERIVED', 'citation': 'Guzick AG, Schneider SC, Kook M, Greenberg R, Perozo-Garcia A, Lee MP, Garcia J, Onyeka OC, Riddle DB, Storch EA. Internet-based, parent-led cognitive behavioral therapy for autistic youth with anxiety-related disorders: A randomized trial comparing email vs. telehealth support. Behav Res Ther. 2024 Dec;183:104639. doi: 10.1016/j.brat.2024.104639. Epub 2024 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the effectiveness of two levels of therapist support for an internet-based, parent-led cognitive behavioral therapy for youth with anxiety and ASD.', 'detailedDescription': 'Autism spectrum disorder, or ASD, is one of the most common neurodevelopmental disorders, affecting up to 1 out of 59 youth in the United States. Anxiety disorders affect 50-80% of children with ASD and are associated with significant life impairment and worsening trajectory without treatment. Cognitive-behavioral therapy (CBT) is an effective treatment for anxiety, yet access to CBT is very limited for most families due to the cost, practicalities of attending in-person treatment sessions and limited availability of trained therapists. Access to CBT is particularly limited for Hispanic or Spanish-speaking families due to lack of services provided in Spanish. Web-based or internet-based delivery of services is a promising method to improve access to care for youth with ASD and their families, given its reachability to a wider range of areas (e.g., rural/underserved) and its ability to minimize practical barriers (e.g., treatment could be delivered to home without need for travel), and reduce stigma (e.g., parents do not need to visit mental health clinics). Thus, the goal of this project is to increase access to care for families of children with ASD and anxiety through an internet-based treatment intervention model. This intervention, developed by the study team, consists of an interactive website with treatment materials that parents can work through with their child, both in English and Spanish.\n\nSpecifically, this project will examine the effectiveness of an internet-based, parent-led cognitive-behavioral therapy (iCBT) for anxiety in children with two levels of therapist support: 1) iCBT-E (therapist support is delivered via email) and 2) iCBT-EV (therapist support is delivered via email and videoconferencing sessions).\n\nThis study will also involve two phases: 1) pilot intervention phase and 2) randomized controlled phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child is between the ages 7-15 years at consent/assent.\n* The child meets criteria for ASD.\n* The child meets criteria for an anxiety and/or obsessive compulsive disorder (OCD) as determined by the Mini Neuropsychiatric Interview for Children and Adolescents\n* Anxiety and/or OCD is the primary presenting problem as determined by the Mini Neuropsychiatric Interview for Children and Adolescents\n* One parent/guardian is able and willing to participate.\n* The child has a Full Scale and Verbal Comprehension Intelligence Quotient \\>70.\n* The child is able to communicate verbally.\n* Participants must reside in Texas and must be in the state of Texas when taking calls.\n\nExclusion Criteria:\n\n* The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.\n* The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.\n* The child is receiving concurrent psychotherapy for anxiety.\n* Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.'}, 'identificationModule': {'nctId': 'NCT05284435', 'briefTitle': 'Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD', 'orgStudyIdInfo': {'id': 'H-51359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iCBT-Email (iCBT-E)', 'description': 'Parents will receive a weekly email from a therapist over the 12 weeks of treatment.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy-Email (iCBT-E)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'iCBT-Email and Videoconferencing (iCBT-EV)', 'description': 'Parents will receive a weekly email and six 30-minute supportive video calls with a therapist over the 12 weeks of treatment.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy-Email (iCBT-E)', 'type': 'BEHAVIORAL', 'description': 'Participating families will receive an access to the website that contains treatment materials for both parent and child.\n\nDuring each of the weekly emails, therapists will serve to provide encouragement and support as the parent works through the program independently.', 'armGroupLabels': ['iCBT-Email (iCBT-E)']}, {'name': 'Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)', 'type': 'BEHAVIORAL', 'description': 'Participating families will receive an access to the website that contains treatment materials for both parent and child.\n\nDuring each of the weekly emails and six videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently. Therapists will also assist the parent with any problem-solving as needed.', 'armGroupLabels': ['iCBT-Email and Videoconferencing (iCBT-EV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrew Guzick', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}