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Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA)

Primary Purpose

Anxiety, Autism Spectrum Disorder, Separation Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Treatment as Usual
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring cognitive behavioral therapy, children, adolescents, anxiety, Community mental health clinics

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The adolescent is between the ages of 7 to 17 upon enrollment with an established autism spectrum disorder diagnosis (ASD) made by a standardized assessment (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition), confirmed by the Social Communication Questionnaire (SCQ) ≥ 11 and/or total score ≥ 7 on the Autism Diagnostic Observation Schedule-2 (ADOS-2). Dr. Storch will review diagnostic reports to determine whether an appropriate ASD diagnosis has been established. The adolescent has clinically elevated symptoms of anxiety based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (>12). Anxiety is the primary concern and the child is appropriate for intervention focus, as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview) by an independent evaluator (IE) supervised by an experienced, licensed psychologist determines that the child is appropriate for the intervention focus. Child has a verbal intelligence quotient > 70, as measured by the Verbal Comprehension Index of the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V). One parent/guardian is able and willing to participate (i.e., available during therapy sessions, attend study assessments). Child is eligible to receive services at the participating clinic. Both parent and child can read and/or understand English and/or Spanish. Both parent and child reside in Texas or Pennsylvania. Exclusion Criteria: 1.) The child has a diagnosis of psychotic disorder as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview). 2.) The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention). 3.) The child is receiving concurrent psychotherapy for anxiety. 4.) If child is taking psychotropic medication, regimen must have been started 8 weeks ago and stable for the past 4 weeks (or 2 weeks for stimulants or benzodiazepines). If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage s/he may be enrolled.

Sites / Locations

  • Hospital of the University of Pennsylvania
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cognitive Behavioral Therapy

Treatment as Usual

Arm Description

Participants will receive cognitive behavioral therapy that has been adapted for autistic youth with anxiety. These sessions will also include components of exposure. Participants will receive therapy around once a week for 14 weeks.

Participants will complete treatment as usual. They will be referred to other community resources, including skills training. Additionally, participants may begin or end therapy and/or medication.

Outcomes

Primary Outcome Measures

Pediatric Anxiety Rating Scale - ASD
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 35. This measure has been modified for autistic youth

Secondary Outcome Measures

Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings
Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.
Clinical Global Impression-Improvement
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= very much improved; 6= very much worse).

Full Information

First Posted
September 14, 2023
Last Updated
October 11, 2023
Sponsor
Baylor College of Medicine
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT06046170
Brief Title
Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA)
Official Title
Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA): A Randomized Control
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2024 (Anticipated)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Anxiety is very common in autistic youth. Recently, an intervention has been created by the investigators to target these symptoms in autistic youth in a community setting. The purpose of this study is to determine the feasibility of implementing this treatment in community care centers.
Detailed Description
As many as 50% of autistic youth have at least 1 anxiety disorder. Cognitive-behavioral therapy (CBT) for autistic youth is effective at treating anxiety, but access is limited. The investigators have tailored the treatment to make it more accessible to families in the participants' home communities. The purpose of this project is to investigate how feasible it is to implement Community-Based Anxiety Programs Tailored for Autism (CAPTA) in community settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Autism Spectrum Disorder, Separation Anxiety, Generalized Anxiety Disorder, Social Anxiety Disorder of Childhood
Keywords
cognitive behavioral therapy, children, adolescents, anxiety, Community mental health clinics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized assignment to one of two conditions
Masking
Outcomes Assessor
Masking Description
Outcomes assessor is blinded
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Participants will receive cognitive behavioral therapy that has been adapted for autistic youth with anxiety. These sessions will also include components of exposure. Participants will receive therapy around once a week for 14 weeks.
Arm Title
Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
Participants will complete treatment as usual. They will be referred to other community resources, including skills training. Additionally, participants may begin or end therapy and/or medication.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Participants will receive cognitive behavioral therapy with elements of exposure in order to target anxious behaviors.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Participants will receive treatment as usual at a community mental health center, including receiving skills training.
Primary Outcome Measure Information:
Title
Pediatric Anxiety Rating Scale - ASD
Description
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 35. This measure has been modified for autistic youth
Time Frame
baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings
Description
Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.
Time Frame
baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up
Title
Clinical Global Impression-Improvement
Description
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= very much improved; 6= very much worse).
Time Frame
baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The adolescent is between the ages of 7 to 17 upon enrollment with an established autism spectrum disorder diagnosis (ASD) made by a standardized assessment (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition), confirmed by the Social Communication Questionnaire (SCQ) ≥ 11 and/or total score ≥ 7 on the Autism Diagnostic Observation Schedule-2 (ADOS-2). Dr. Storch will review diagnostic reports to determine whether an appropriate ASD diagnosis has been established. The adolescent has clinically elevated symptoms of anxiety based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (>12). Anxiety is the primary concern and the child is appropriate for intervention focus, as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview) by an independent evaluator (IE) supervised by an experienced, licensed psychologist determines that the child is appropriate for the intervention focus. Child has a verbal intelligence quotient > 70, as measured by the Verbal Comprehension Index of the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V). One parent/guardian is able and willing to participate (i.e., available during therapy sessions, attend study assessments). Child is eligible to receive services at the participating clinic. Both parent and child can read and/or understand English and/or Spanish. Both parent and child reside in Texas or Pennsylvania. Exclusion Criteria: 1.) The child has a diagnosis of psychotic disorder as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview). 2.) The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention). 3.) The child is receiving concurrent psychotherapy for anxiety. 4.) If child is taking psychotropic medication, regimen must have been started 8 weeks ago and stable for the past 4 weeks (or 2 weeks for stimulants or benzodiazepines). If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage s/he may be enrolled.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Whitney Shepherd, B.A
Phone
713-798-8563
Email
whitney.shepherd@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Storch, Ph.D.
Phone
713-198-3080
Email
eric.storch@bcm.edu
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Guzick, Ph.D.
Email
andrew.guzick@pennmedicine.upenn.edu
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Storch, Ph.D.
Phone
713-798-3080
Email
eric.storch@bcm.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Adaptation and Feasibility of the Community-Based Anxiety Program Tailored for Autism (CAPTA)

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