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Treatment for Children With Autism and Anxiety

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Facing Your Fears
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Clinicians must (1) be at the level of graduate student (or higher) in either a masters or doctoral program in clinical, counseling or school psychology; and (2)be working in an outpatient clinical setting serving children with ASD
  • Children must (1) be 8-14 years of age; (2) living with someone who can give informed consent to participate;
  • Children must have a diagnosis of ASD as defined by (a) Autism Diagnostic Observation Schedule (ADOS; Lord et al. 1999) score above spectrum cutoff; (b) Social Communication Questionnaire (SCQ; Berument et al. 1999) score above cutoff; and (c) clinical diagnosis of an ASD as determined by a review of history and current clinical presentation by a clinical psychologist and assigning one of the following diagnoses: Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder - Not Otherwise Specified.
  • Children must have an estimated Verbal IQ of 80 or above as determined through standardized cognitive testing using the Wechsler Abbreviated Scales of Intelligence (WASI; Wechsler, 2002), or an equivalent measure of intelligence that has been administered within the past two years, and attempts to engage verbally with the examiner during the administration of Module 3 of the ADOS.
  • Children must be able to read at a mid-2nd-grade level: Many activities involve narrative approaches and early reading is a pre-requisite skill for this intervention package; (as assessed by the Letter-Word Identification and Reading Comprehension subtests of the Woodcock Johnson Achievement Tests - Third Edition; WJ-III; Woodcock, McGrew, & Mather, 2001).
  • Children must evince clinically significant symptoms of either , SAD, GAD, or SP anxiety and this impairment is "primary" or more functionally significant than another disorder (such as depression) as determined by the clinician evaluator. Children with clinically significant scores on SpP will also be included, although SpP cannot be the sole anxiety diagnosis for the child.
  • Parents must (1) be the parent of a child with ASD and clinical anxiety as defined above and can give consent for the child to participate in the study; and (2) include men and women between the ages of 24-65.

Exclusion Criteria:

  • Clinician-trainees: (1) Inability to attend at least 11/14 group sessions
  • Children: (1) child is not fluent in English; (2) family cannot commit to having a minimum of 1 parent and 1 child attending 11 of 14 sessions within the intervention period; (3) child presents with psychosis, severe aggressive behavior, or other severe clinical symptoms that require more intensive treatment such as day treatment or hospitalization; (4) family plans to seek additional psychosocial treatment for anxiety during enrollment through treatment; (5) child is not able to separate from parent for a minimum of 30 minutes within the qualifying sessions; Because the parent and child interventions occur simultaneously, if a child has significant issues separating from the parent, it makes it difficult for the parent to participate in their portion of the assessment.
  • Parents: (1) Parent is not fluent in English; (2) Parent is unable to attend 11/14 sessions within the intervention period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Facing Your Fears

    Arm Description

    FYF is a group CBT approach to managing anxiety symptoms in children with high-functioning autism spectrum disorders and anxiety.

    Outcomes

    Primary Outcome Measures

    Change in Clinical Global Impression Scale - Improvement and Severity (CGIS-S; CGIS-I)
    CGIS-S and CGIS-I ratings were completed by an independent clinical evaluator based on scores derived from the ADIS-P and the SCARED. They were compared pre and post treatment to monitor change in anxiety symptoms.

    Secondary Outcome Measures

    Anxiety Disorders Interview Survey for Children-Parent Version (ADIS-P)
    The ADIS-P is a semi-structured psychiatric interview designed to assess the presence of psychiatric diagnoses, specifically anxiety disorders. Ratings were compared pre and post intervention to monitor change in anxiety symptoms.

    Full Information

    First Posted
    October 30, 2012
    Last Updated
    November 12, 2012
    Sponsor
    University of Colorado, Denver
    Collaborators
    Autism Speaks
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01727466
    Brief Title
    Treatment for Children With Autism and Anxiety
    Official Title
    A Randomized Trial: Group Cognitive Behavior Therapy for Children With High-Functioning Autism Spectrum Disorders and Anxiety
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    Autism Speaks

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Children with high-functioning autism spectrum disorders (ASD) are at high risk for developing significant anxiety symptoms. Cognitive behavior therapies (CBT) are frequently used for children with anxiety symptoms with good success. The purpose of the current study was to examine the efficacy of a family-focused group CBT program (Facing Your Fears [FYF]) compared to Treatment As Usual (TAU). Participants were randomized to either active treatment or TAU. It was hypothesized that children who completed the active treatment would demonstrate improvement in their anxiety symptoms relative to children in TAU.
    Detailed Description
    Children with ASD and anxiety in our initial studies have displayed reductions in anxiety symptoms following the delivery of the FYF intervention. Given these initial successes, there are two primary purposes of this study. First, to train outpatient clinicians to fidelity on the FYF intervention for 8-14 year old children with high-functioning ASD and clinical anxiety. Second, to develop an optimal training model for learning the FYF intervention. The primary aims of Phase 1 are to develop a training manual and deliver a workshop on the FYF model to a group of outpatient clinicians in preparation for the clinicians to deliver the FYF intervention to four groups of children with ASD and anxiety. In Phase 2, the primary aims include comparing three instruction methods of learning to clinicians at three different outpatient clinics, by assessing increases in clinicians' acquisition of the intervention techniques and estimating the degree of reduction in anxiety symptoms on the primary outcome measures for the children with ASD. Instruction methods are: a) Manual, b) Workshop, c) Workshop-Plus. We hypothesize that clinicians receiving the Workshop-Plus (workshop plus ongoing consultation) condition will achieve treatment fidelity at a faster rate than clinicians receiving the other two instruction methods, and the children with ASD in the Workshop-Plus condition will display greater reductions in anxiety symptoms compared to the children in the other two conditions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Facing Your Fears
    Arm Type
    Experimental
    Arm Description
    FYF is a group CBT approach to managing anxiety symptoms in children with high-functioning autism spectrum disorders and anxiety.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Facing Your Fears
    Intervention Description
    FYF is a group cognitive behavior therapy that includes parent and child participation. Groups meet weekly for 1 1/2 hours duration, for 14 consecutive weeks.
    Primary Outcome Measure Information:
    Title
    Change in Clinical Global Impression Scale - Improvement and Severity (CGIS-S; CGIS-I)
    Description
    CGIS-S and CGIS-I ratings were completed by an independent clinical evaluator based on scores derived from the ADIS-P and the SCARED. They were compared pre and post treatment to monitor change in anxiety symptoms.
    Time Frame
    Administered pre and post intervention up to 12 months after final session
    Secondary Outcome Measure Information:
    Title
    Anxiety Disorders Interview Survey for Children-Parent Version (ADIS-P)
    Description
    The ADIS-P is a semi-structured psychiatric interview designed to assess the presence of psychiatric diagnoses, specifically anxiety disorders. Ratings were compared pre and post intervention to monitor change in anxiety symptoms.
    Time Frame
    Administered pre and post intervention up to 12 months after the final session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Clinicians must (1) be at the level of graduate student (or higher) in either a masters or doctoral program in clinical, counseling or school psychology; and (2)be working in an outpatient clinical setting serving children with ASD Children must (1) be 8-14 years of age; (2) living with someone who can give informed consent to participate; Children must have a diagnosis of ASD as defined by (a) Autism Diagnostic Observation Schedule (ADOS; Lord et al. 1999) score above spectrum cutoff; (b) Social Communication Questionnaire (SCQ; Berument et al. 1999) score above cutoff; and (c) clinical diagnosis of an ASD as determined by a review of history and current clinical presentation by a clinical psychologist and assigning one of the following diagnoses: Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder - Not Otherwise Specified. Children must have an estimated Verbal IQ of 80 or above as determined through standardized cognitive testing using the Wechsler Abbreviated Scales of Intelligence (WASI; Wechsler, 2002), or an equivalent measure of intelligence that has been administered within the past two years, and attempts to engage verbally with the examiner during the administration of Module 3 of the ADOS. Children must be able to read at a mid-2nd-grade level: Many activities involve narrative approaches and early reading is a pre-requisite skill for this intervention package; (as assessed by the Letter-Word Identification and Reading Comprehension subtests of the Woodcock Johnson Achievement Tests - Third Edition; WJ-III; Woodcock, McGrew, & Mather, 2001). Children must evince clinically significant symptoms of either , SAD, GAD, or SP anxiety and this impairment is "primary" or more functionally significant than another disorder (such as depression) as determined by the clinician evaluator. Children with clinically significant scores on SpP will also be included, although SpP cannot be the sole anxiety diagnosis for the child. Parents must (1) be the parent of a child with ASD and clinical anxiety as defined above and can give consent for the child to participate in the study; and (2) include men and women between the ages of 24-65. Exclusion Criteria: Clinician-trainees: (1) Inability to attend at least 11/14 group sessions Children: (1) child is not fluent in English; (2) family cannot commit to having a minimum of 1 parent and 1 child attending 11 of 14 sessions within the intervention period; (3) child presents with psychosis, severe aggressive behavior, or other severe clinical symptoms that require more intensive treatment such as day treatment or hospitalization; (4) family plans to seek additional psychosocial treatment for anxiety during enrollment through treatment; (5) child is not able to separate from parent for a minimum of 30 minutes within the qualifying sessions; Because the parent and child interventions occur simultaneously, if a child has significant issues separating from the parent, it makes it difficult for the parent to participate in their portion of the assessment. Parents: (1) Parent is not fluent in English; (2) Parent is unable to attend 11/14 sessions within the intervention period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Judy Reaven, PhD
    Organizational Affiliation
    UC Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment for Children With Autism and Anxiety

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