Baylor College of Medicine
Houston, Texas, 77030, United States
NCT Number: NCT05284435
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.
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Notify Me7 year–15 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Specifically, 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).
This study will also involve two phases: 1) pilot intervention phase and 2) randomized controlled phase.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participating families will receive an access to the website that contains treatment materials for both parent and child.
During each of the weekly emails, therapists will serve to provide encouragement and support as the parent works through the program independently.
Participating families will receive an access to the website that contains treatment materials for both parent and child.
During 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.
Time frame: 7 days
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.
Time frame: 7 days
Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).
Time frame: 7 days
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.
Time frame: 7 days
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.
Time frame: 7 days
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.
Time frame: 7 days
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.
Baylor College of Medicine
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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