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

NCT05284435 | Completed

• 1 other identifier: H-51359
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Revised Child Anxiety and Depression Scale- Parent-Report- Anxiety Subscale

  7 days

• Revised Child Anxiety and Depression Scale- Self-Report- Anxiety Subscale

  7 days

• Social Responsiveness Scale, Second Edition

  7 days

• Sheehan Disability Scale

  7 days

Study Arms (2)

iCBT-Email (iCBT-E)

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy-Email (iCBT-E)

iCBT-Email and Videoconferencing (iCBT-EV)

ACTIVE COMPARATOR

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)

Interventions

Cognitive Behavioral Therapy-Email (iCBT-E) BEHAVIORAL

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.

iCBT-Email (iCBT-E)

Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV) BEHAVIORAL

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.

iCBT-Email and Videoconferencing (iCBT-EV)

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

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 (1)

• Guzick AG, Schneider SC, Kook M, Greenberg R, Perozo-Garcia A, Lee MP, Garcia J, Onyeka OC, Riddle DB, Storch EA. Internet-based, parent-led cognitive behavioral therapy for autistic youth with anxiety-related disorders: A randomized trial comparing email vs. telehealth support. Behav Res Ther. 2024 Dec;183:104639. doi: 10.1016/j.brat.2024.104639. Epub 2024 Sep 29.

  PMID: 39368459 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

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: March 9, 2022
• First Posted: March 17, 2022
• Study Start: March 28, 2022
• Primary Completion: August 21, 2023
• Study Completion: December 17, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)