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

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

Detailed Description
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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.

Official Title
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Parent-Led Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Co-occurring Anxiety

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

Intervention / Treatment
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* Behavioral: Stepped Care CBT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group observational.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stepped Care CBT<br>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. | Behavioral: Stepped Care CBT<br>* 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.<br>|

What is the study measuring?
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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. | 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 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). | 7 days |