Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Anxiety

NCT ID: NCT03720795

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-12-31

Brief Summary

This study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.

Detailed Description

Autism spectrum disorder (ASD) affects as many as 1 out of 59 individuals, with many higher-functioning youth not diagnosed until school-age or later. This equates to ~102,000 children under the age of 14 years in the state of Texas alone. Significant impairment in social and adaptive functioning are common, as are comorbid behavioral health disorders, with anxiety disorders affecting between 50-80% of youth with ASD. Given the relative frequency of anxiety disorders among children with ASD, the associated impairment, and worsening trajectory over time without intervention, there is a great need for treatment that specifically addresses anxiety-related symptoms in ASD. Cognitive-behavioral therapy (CBT) has been established as a first-line treatment for anxiety disorders among youth with and without ASD. A particular form of CBT, Behavioral Intervention for Anxiety in Children with ASD (BIACA), has demonstrated efficacy in a number of studies. However, treatment is delivered by therapists as "full-packages" (i.e., 12-16 clinic sessions), which can be therapist-intensive, costly, impractical for families, and not responsive to parental preferences. Alternatives approaches, such as parent-led, stepped-care models that improve accessibility, are efficient, provide personalized care, and lower mental health treatment cost, are greatly needed. Stepped-care models provide a lower-intensity first step (e.g., parent-led, less costly, and more convenient for parents) as the initial treatment with the assumption that a proportion of individuals will respond to the first step and others will need to step up to more intensive treatment. Matching treatment to families' needs and tailoring subsequent treatment may be an efficient and effective approach, as well as consistent with parents' desire to help their child. Given this, together with the substantial impairment associated with clinical anxiety in individuals with ASD across the age span, this study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stepped Care CBT

Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each.

Group Type: OTHER

Stepped Care CBT

Intervention Type: BEHAVIORAL

Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions.

Interventions

Stepped Care CBT

Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Child is between the ages 4-14 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 attend.
• The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70.

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Eric A Storch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

BCM SC-CBT001

Identifier Type: -

Identifier Source: org_study_id