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

NCT ID: NCT05284435

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2023-12-17

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.

Conditions

Cognitive Behavioral Therapy; Autism Spectrum Disorder; Anxiety Disorder; Obsessive-Compulsive Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder; Specific Phobia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

iCBT-Email (iCBT-E)

Parents will receive a weekly email from a therapist over the 12 weeks of treatment.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy-Email (iCBT-E)

Intervention Type: BEHAVIORAL

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.

iCBT-Email and Videoconferencing (iCBT-EV)

Parents will receive a weekly email and six 30-minute supportive video calls with a therapist over the 12 weeks of treatment.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)

Intervention Type: BEHAVIORAL

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.

Interventions

Cognitive 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.

Intervention Type: BEHAVIORAL

Cognitive 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Andrew Guzick

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39368459 (View on PubMed)

Other Identifiers

H-51359

Identifier Type: -

Identifier Source: org_study_id