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
About this trial
This is an interventional treatment trial for Autism
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
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
NCT ID
NCT01727466
First Posted
October 30, 2012
Last Updated
November 12, 2012
Sponsor
University of Colorado, Denver
Collaborators
Autism Speaks
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
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Treatment for Children With Autism and Anxiety
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