Treatment for Children With Autism and Anxiety

NCT ID: NCT01727466

Last Updated: 2012-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-12-31

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.

Conditions

Autism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Facing Your Fears

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

Group Type: EXPERIMENTAL

Facing Your Fears

Intervention Type: BEHAVIORAL

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.

Interventions

Facing Your Fears

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Autism Speaks

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judy Reaven, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Denver

Other Identifiers

03-0245

Identifier Type: -

Identifier Source: org_study_id