NCT01187784

Brief Summary

Many children and adolescents with autism spectrum disorder (ASD) experience high levels of anxiety which can further inhibit their ability to master developmental tasks such as succeeding in school and developing and maintaining friendships. Despite the need for effective treatments for children with ASD and anxiety, there have been few studies that have addressed this issue. Recently, preliminary evidence has supported the use of cognitive-behavioral therapy (CBT) to treat anxiety disorders in children with ASD. This study will utilize a CBT treatment program called Coping Cat. Coping Cat has been found to be one of the most effective treatments for typically developing children with anxiety and has also been shown to be effective for treating anxiety in children with other disorders such as physical impairments, selective mutism, and Attention Deficit Hyperactivity Disorder. The investigators goal is to demonstrate that Coping Cat is an effective treatment for children with ASD and anxiety. Finding effective treatments for children with ASD and anxiety could increase adaptive social relationships, decrease stress among families, and prevent the maintenance of anxiety into adulthood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

1.3 years

First QC Date

August 23, 2010

Last Update Submit

August 23, 2010

Conditions

Autism Spectrum DisorderAutismAsperger SyndromePDD-NOS

Outcome Measures

Primary Outcomes (1)

  • Anxiety Disorders Interview Schedule - Child/Parent Version

    Scores on parent-administered anxiety diagnostic interview after treatment or waitlist.

    Post Treatment (16 weeks)

Secondary Outcomes (2)

  • Multidimensional Anxiety Scale for Children

    Post Treatment (16 weeks)

  • Spence Children's Anxiety Scale (Child and Parent Versions)

    Post Treatment (16 weeks)

Study Arms (2)

CBT

ACTIVE COMPARATOR

Coping Cat cognitive-behavioral therapy protocol

Behavioral: Coping Cat cognitive-behavioral therapy for anxious youth

Waitlist Control

NO INTERVENTION

Treatment as usual

Interventions

Coping Cat cognitive-behavioral therapy for anxious youthBEHAVIORAL

Manualized, empirically supported CBT treatment for anxious youth

CBT

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years
  • Diagnosis of an autism spectrum disorder (meets DSM-IV criteria for autism, Asperger syndrome, or Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS))
  • Clinically significant anxiety (meets DSM-IV criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder)
  • IQ \> 70
  • Primary spoken language: English

You may not qualify if:

  • IQ \< 70
  • Comorbid psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alliant International University

San Diego, California, 92131, United States

Location

Related Publications (1)

  • McNally Keehn RH, Lincoln AJ, Brown MZ, Chavira DA. The Coping Cat program for children with anxiety and autism spectrum disorder: a pilot randomized controlled trial. J Autism Dev Disord. 2013 Jan;43(1):57-67. doi: 10.1007/s10803-012-1541-9.

    PMID: 22588377DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderAsperger Syndrome

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Rebecca McNally Keehn, M.A.

    Alliant International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

May 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

US(1)