Treatment for Children With Autism and Anxiety

Not Applicable

Completed

• Conditions: Autism
• Interventions: Behavioral: Facing Your Fears

• Registration Number: NCT01727466
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Status Verified: 2012-10
• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-11-12
• Last Update Submitted: 2012-11-12
• Study First Posted: 2012-11-16
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Facing Your Fears	Facing Your Fears	FYF is a group CBT approach to managing anxiety symptoms in children with high-functioning autism spectrum disorders and anxiety.

Primary Outcome Measures

Name	Time	Method
Change in Clinical Global Impression Scale - Improvement and Severity (CGIS-S; CGIS-I)	Administered pre and post intervention up to 12 months after final session	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

Name	Time	Method
Anxiety Disorders Interview Survey for Children-Parent Version (ADIS-P)	Administered pre and post intervention up to 12 months after the final session	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.