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Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD

Primary Purpose

Cognitive Behavioral Therapy, Autism Spectrum Disorder, Anxiety Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Teletherapy LTA
Cognitive Behavioral Teletherapy STA
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 - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child is between the ages 7-13 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 parents 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 Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-Intensity Therapist Assistance (LTA)

Standard Therapist Assistance (STA)

Arm Description

Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment.

Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment.

Outcomes

Primary Outcome Measures

6-item Pediatric Anxiety Rating Scale
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

Clinical Global Impression-Severity
Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).

Full Information

First Posted
September 30, 2019
Last Updated
February 7, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04111874
Brief Title
Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD
Official Title
Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.
Detailed Description
Anxiety disorders affect 50-80% of children with autism spectrum disorder (ASD) and are associated with significant life impairment and worsening trajectory without treatment. The most effective psychotherapy for anxiety in youth with and without ASD is cognitive behavioral therapy (CBT), but many families are not able to access CBT due to the cost, practicalities of attending treatment sessions, and limited availability of trained therapists. Alternative models of service delivery are greatly needed, with particular promise of parent-led therapist-assisted (PLTA) models and telehealth delivery formats. Parents may benefit from additional information regarding how to optimize the delivery of CBT for youths with ASD given the potential impact of ASD symptomology on core CBT skills. Thus, this project aims to improve access to anxiety-focused Parent-Led Therapist-Assisted CBT for parents of youth with ASD. Parent-led low-intensity treatment models can improve accessibility, efficiency, and mental health treatment cost. Lower intensity treatment models provide a treatment option that is less costly and burdensome for parents; it is understood that some individuals will respond to the first step and others will require additional treatment to achieve anxiety reduction. However, understanding how many families, and which families, can benefit from a lower intensity model has dramatic benefits for improving access, allocating more intensive services for those most in need, and reducing barriers (e.g., distance). Thus, this study will examine the effectiveness of two anxiety-focused PTLA CBT telehealth models: 1) low-intensity therapist assistance (LTA) and 2) standard therapist assistance (STA). Overall, this study will provide important information regarding the potential benefits of two different approaches to parent-led interventions for youth with ASD and anxiety when delivered via telehealth.

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 Disorders, 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
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Intensity Therapist Assistance (LTA)
Arm Type
Experimental
Arm Description
Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment.
Arm Title
Standard Therapist Assistance (STA)
Arm Type
Active Comparator
Arm Description
Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Teletherapy LTA
Intervention Description
Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Teletherapy STA
Intervention Description
Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.
Primary Outcome Measure Information:
Title
6-item Pediatric Anxiety Rating Scale
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
Clinical Global Impression-Severity
Description
Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child is between the ages 7-13 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 parents 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.
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34693989
Citation
Elliott SJ, Marshall D, Morley K, Uphoff E, Kumar M, Meader N. Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2021 Sep 3;9(9):CD013173. doi: 10.1002/14651858.CD013173.pub2.
Results Reference
derived

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Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD

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