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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Autism Spectrum Disorder; Social Anxiety Disorder; Specific Phobia; Anxiety Disorder; Cognitive Behavioral Therapy
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy-Email (iCBT-E); Behavioral: Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iCBT-Email (iCBT-E); Parents will receive a weekly email from a therapist over the 12 weeks of treatment.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression-Improvement	Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).	7 days
5-item Pediatric Anxiety Rating Scale - Autism Spectrum Disorder	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Child Anxiety and Depression Scale- Parent-Report- Anxiety Subscale	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.	7 days
Revised Child Anxiety and Depression Scale- Self-Report- Anxiety Subscale	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.	7 days
Social Responsiveness Scale, Second Edition	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.	7 days
Sheehan Disability Scale	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.	7 days

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): December 17, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Phobic Disorders; Obsessive-Compulsive Disorder; Anxiety Disorders; Autism Spectrum Disorder; Phobia, Social
• Other Study ID Numbers: H-51359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No