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

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ClinicalTrials.gov Identifier: NCT03720795
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Alan Storch, Baylor College of Medicine

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

Condition or disease Intervention/treatment Phase
Cognitive Behavioral Therapy Autism Spectrum Disorder Anxiety Disorders Obsessive-Compulsive Disorder Social Anxiety Disorder Generalized Anxiety Disorder Specific Phobia Behavioral: Stepped Care CBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group observational.
Masking: None (Open Label)
Masking Description: The rater is unaware of treatment status, that is if the child continues to receive treatment after Step 1 (versus being in maintenance).
Primary Purpose: Treatment
Official Title: Parent-Led Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Co-occurring Anxiety
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
Behavioral: 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.




Primary Outcome Measures :
  1. 6-item Pediatric Anxiety Rating Scale [ Time Frame: 7 days ]
    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.

  2. Clinical Global Impression-Improvement [ Time Frame: 7 days ]
    Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).


Secondary Outcome Measures :
  1. Clinical Global Impression-Severity [ Time Frame: 7 days ]
    Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720795


Contacts
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Contact: Eric Storch, Ph.D. 713-798-1495 eric.storch@bcm.edu
Contact: Sophie Schneider, Ph.D. 713-798-1495 sophie.schneider@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Ana C Ramirez    713-798-2465    ana.ramirez@bcm.edu   
Principal Investigator: Eric A Storch, PhD         
Sub-Investigator: Robin P Kochel, PhD         
Sub-Investigator: Leandra Berry, PhD         
Sponsors and Collaborators
Baylor College of Medicine

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Responsible Party: Eric Alan Storch, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03720795     History of Changes
Other Study ID Numbers: BCM SC-CBT001
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Phobia, Social
Pathologic Processes
Mental Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Personality Disorders
Phobic Disorders