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

Primary Purpose

Cognitive Behavioral Therapy, Autism Spectrum Disorder, Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy-Email (iCBT-E)
Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Behavioral Therapy

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child is between the ages 7-15 years at consent/assent.
  • The child meets criteria for ASD.
  • The child meets criteria for clinically significant anxiety and/or OCD symptoms.
  • Anxiety and/or OCD is the primary presenting problem.
  • 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.

Sites / Locations

  • Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iCBT-Email (iCBT-E)

iCBT-Email and Videoconferencing (iCBT-EV)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 9, 2022
Last Updated
June 22, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05284435
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Behavioral Therapy, Autism Spectrum Disorder, Anxiety Disorder, Obsessive-Compulsive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, Specific Phobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iCBT-Email (iCBT-E)
Arm Type
Experimental
Arm Description
Parents will receive a weekly email from a therapist over the 12 weeks of treatment.
Arm Title
iCBT-Email and Videoconferencing (iCBT-EV)
Arm Type
Active Comparator
Arm Description
Parents will receive a weekly email and six 30-minute supportive video calls with a therapist over the 12 weeks of treatment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy-Email (iCBT-E)
Intervention Description
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
Intervention Name(s)
Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)
Intervention Description
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.
Primary Outcome Measure Information:
Title
5-item Pediatric Anxiety Rating Scale - Autism Spectrum Disorder
Description
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.
Time Frame
7 days
Title
Clinical Global Impression-Improvement
Description
Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Revised Child Anxiety and Depression Scale- Parent-Report- Anxiety Subscale
Description
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.
Time Frame
7 days
Title
Revised Child Anxiety and Depression Scale- Self-Report- Anxiety Subscale
Description
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.
Time Frame
7 days
Title
Social Responsiveness Scale, Second Edition
Description
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.
Time Frame
7 days
Title
Sheehan Disability Scale
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Guzick, Ph.D.
Phone
713-798-3080
Email
andrew.guzick@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Storch, Ph.D.
Phone
713-798-3080
Email
eric.storch@bcm.edu
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saira Weinzimmer
Phone
713-798-8563
Email
Saira.Weinzimmer@bcm.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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