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

This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Autism Spectrum Disorder; Social Anxiety Disorder; Specific Phobia; Cognitive Behavioral Therapy
• Intervention / Treatment: Behavioral: Cognitive Behavioral Teletherapy LTA; Behavioral: Cognitive Behavioral Teletherapy STA

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• 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 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

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: Low-Intensity Therapist Assistance (LTA); Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment.	Behavioral: Cognitive Behavioral Teletherapy LTA; 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.
Active Comparator: Standard Therapist Assistance (STA); Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment.	Behavioral: Cognitive Behavioral Teletherapy STA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
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).	Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression-Severity	Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).	Baseline (before treatment), Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Phobic Disorders; Autism Spectrum Disorder; Phobia, Social; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID Numbers: H45203

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