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

NCT04111874 | Completed Results

• 1 other identifier: H45203
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical Global Impression-Severity

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

Study Arms (2)

Low-Intensity Therapist Assistance (LTA)

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Teletherapy LTA

Standard Therapist Assistance (STA)

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Teletherapy STA

Interventions

Cognitive Behavioral Teletherapy LTA BEHAVIORAL

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.

Low-Intensity Therapist Assistance (LTA)

Cognitive Behavioral Teletherapy STA BEHAVIORAL

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.

Standard Therapist Assistance (STA)

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Guzick AG, Schneider SC, Kook M, Rose Iacono J, Weinzimmer SA, Quast T, Olsen SM, Hughes KR, Jellinek-Russo E, Garcia AP, Candelari A, Berry LN, Goin-Kochel RP, Goodman WK, Storch EA. Parent-Led Cognitive Behavioral Teletherapy for Anxiety in Autistic Youth: A Randomized Trial Comparing Two Levels of Therapist Support. Behav Ther. 2024 May;55(3):499-512. doi: 10.1016/j.beth.2023.08.008. Epub 2023 Sep 6.

  PMID: 38670664 DERIVED

• Greenberg RL, Guzick AG, Schneider SC, Weinzimmer SA, Kook M, Perozo Garcia AB, Storch EA. Depressive Symptoms in Autistic Youth with Anxiety Disorders. J Dev Behav Pediatr. 2023 Dec 1;44(9):e597-e603. doi: 10.1097/DBP.0000000000001223. Epub 2023 Oct 11.

  PMID: 38019467 DERIVED

• 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.

  PMID: 34693989 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders; Obsessive-Compulsive Disorder; Phobia, Social; Generalized Anxiety Disorder; Phobia, Specific

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Phobic Disorders

Results Point of Contact

• Title: Dr. Andrew Guzick
• Organization: University of Pennsylvania

andrew.guzick@pennmedicine.upenn.edu

215-573-3708

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 1, 2019
• Study Start: July 30, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)