NCT06537128

Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety

Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety: Development and Evaluation of Learning to Understand and Navigate Anxiety-Adolescent

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.

Detailed description

Autism affects 2-3% of youth, approximately half of whom experience a co-occurring anxiety disorder. Anxiety disorders in autistic youth are associated with significant life impairment and worsening trajectory without treatment. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. Access to CBT is particularly limited for Hispanic or Spanish-speaking families due to lack of services provided in Spanish. Internet-delivered therapies such as iCBT provide low intensity but effective intervention and overcomes barriers such as cost, travel, time from work/school, and stigma. Studies suggest that iCBT protocols for anxious typically-developing youth demonstrate moderate to strong effect sizes relative to control groups. However, until recently, such treatment models have not been developed with stakeholder engagement to be personalized for autistic children with anxiety and their families, including for those families that speak Spanish. In a previous Texas Higher Education Coordinating Board (THECB) funded work, a parent-led iCBT intervention for anxiety among autistic youth, Learning to Understand and Navigate Anxiety (LUNA) was developed. Over 60% of participants demonstrated response to treatment, yet children responded better than adolescents. Family feedback indicated that the materials were not developmentally appropriate for adolescents, necessitating further efforts to develop and evaluate an adapted version which is personalized to the unique needs of autistic adolescents with anxiety. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model (LUNA-Adolescent). This treatment model, developed by the study team, consists of an interactive website with both parent- and adolescent-facing treatment materials, supported by brief therapist contact (e.g. telehealth sessions), both in English and Spanish. Specifically, this project will evaluate the efficacy and cost effectiveness of LUNA-Adolescent compared to standard-care CBT for anxiety. Overall, this study will provide important information regarding the potential benefits of internet-based, parent-led interventions for autistic adolescents with anxiety and its two different delivery models.

Conditions

• Autism Spectrum Disorder
• Autism
• Anxiety
• Anxiety Disorders
• Generalized Anxiety Disorder
• Social Anxiety Disorder

Interventions

Type	Name	Description
BEHAVIORAL	LUNA-Adolescent	Learning to Understand and Navigate Anxiety-Adolescent (LUNA-Adolescent) includes parent-led, internet-based cognitive behavioral therapy (CBT) for anxiety among autistic youth.
BEHAVIORAL	Treatment as Usual	Treatment as Usual includes 12 weekly sessions of transdiagnostic cognitive behavioral therapy (CBT) for anxiety in autistic youth.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-08-05
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States