Clinical Trials Directory

Trials / Completed

CompletedNCT05284435

Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
114 (actual)
Sponsor
Baylor College of Medicine · Academic / Other
Sex
All
Age
7 Years – 15 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioral Therapy-Email (iCBT-E)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.
BEHAVIORALCognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)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.

Timeline

Start date
2022-03-28
Primary completion
2023-08-21
Completion
2023-12-17
First posted
2022-03-17
Last updated
2023-12-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05284435. Inclusion in this directory is not an endorsement.