Clinical trial NCT05284435: Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD
Official title: Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Behavioral Therapy
Autism Spectrum Disorder
Anxiety Disorder
Obsessive-Compulsive Disorder
Social Anxiety Disorder
Generalized Anxiety Disorder
Specific Phobia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 114
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Child is between the ages 7-15 years at consent/assent.
* The child meets criteria for ASD.
* The child meets criteria for an anxiety and/or obsessive compulsive disorder (OCD) as determined by the Mini Neuropsychiatric Interview for Children and Adolescents
* Anxiety and/or OCD is the primary presenting problem as determined by the Mini Neuropsychiatric Interview for Children and Adolescents
* One parent/guardian is able and willing to participate.
* The child has a Full Scale and Verbal Comprehension Intelligence Quotient \>70.
* The child is able to communicate verbally.
* Participants must reside in Texas and must be in the state of Texas when taking calls.

Exclusion Criteria:

* The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.
* The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
* The child is receiving concurrent psychotherapy for anxiety.
* 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.

Primary outcomes:
measure: 5-item Pediatric Anxiety Rating Scale - Autism Spectrum Disorder
timeFrame: 7 days
measure: Clinical Global Impression-Improvement
timeFrame: 7 days
Secondary outcomes:
measure: Revised Child Anxiety and Depression Scale- Parent-Report- Anxiety Subscale
timeFrame: 7 days
measure: Revised Child Anxiety and Depression Scale- Self-Report- Anxiety Subscale
timeFrame: 7 days
measure: Social Responsiveness Scale, Second Edition
timeFrame: 7 days
measure: Sheehan Disability Scale
timeFrame: 7 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: