Autism Spectrum DisorderPhase 1NCT01187784
Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety
A Phase 1 study testing Coping Cat cognitive-behavioral therapy for anxious youth in people with Autism Spectrum Disorder and Autism, run by Alliant International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism, Asperger Syndrome
- What is being tested?
- Coping Cat cognitive-behavioral therapy for anxious youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7 - 14 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
Who cannot join
- IQ < 70
- Comorbid psychotic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Alliant International University
San Diego, California, 92131
About this study
Official title: Effectiveness of Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety
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.
Read the detailed description
The purpose of the current study is to evaluate the effectiveness of an empirically-supported, individually-based cognitive-behavioral treatment for anxiety disorders in children with autism spectrum disorder (ASD). Recent research suggests that 47 - 84% of children with ASD experience clinically significant levels of anxiety due to inhibited temperament, physiological hyperarousal, and distinct information processing biases. Despite the clear need for effective treatments for children with ASD and anxiety, there have been few empirical studies. However, a small body of literature has demonstrated growing support for the use of cognitive-behavioral therapy (CBT) to treat anxiety in children with high-functioning ASD. Kendall and Hedtke's Coping Cat cognitive-behavioral therapy program for anxious children will be utilized as the primary intervention. To date, there are no studies that have used this treatment program for anxiety in children with developmental disorders, including ASD. However, Coping Cat has been successfully adapted for children with a variety of co-occurring diagnoses (e.g., physical impairments, selective mutism). Participants in this study will be 20 children aged 7;0 to 14;11 years diagnosed with high-functioning ASD and at least one anxiety disorder (separation anxiety disorder, generalized anxiety disorder, or social phobia). A randomized controlled trial design will be employed. It is hypothesized that participants in the CBT condition will demonstrate a significantly larger reduction in overall levels of anxiety from pre-treatment to post-treatment compared to those in the waitlist (WL) condition and that children who complete the CBT treatment will maintain gains at two-month follow-up.
- Conditions
- Autism Spectrum Disorder, Autism, Asperger Syndrome, PDD-NOS
- Being tested
- Coping Cat cognitive-behavioral therapy for anxious youth
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Cat cognitive-behavioral therapy for anxious youthBehavioural
Manualized, empirically supported CBT treatment for anxious youth
| Study group | Role | What they receive |
|---|---|---|
| CBT | Active comparator | Coping Cat cognitive-behavioral therapy protocol Receives: Behavioral: Coping Cat cognitive-behavioral therapy for anxious youth |
| Waitlist Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule - Child/Parent Version
Scores on parent-administered anxiety diagnostic interview after treatment or waitlist.
Measured: Post Treatment (16 weeks)
Secondary outcomes (2)
Multidimensional Anxiety Scale for Children
Scores on self-report anxiety rating scale after treatment or waitlist.
Measured: Post Treatment (16 weeks)
Spence Children's Anxiety Scale (Child and Parent Versions)
Scores on self-and parent-report anxiety rating scale after treatment or waitlist.
Measured: Post Treatment (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startMay 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliant International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Foundation for Autism Research, Autism Society of America - San Diego Chapter
- Investigators
- Rebecca McNally Keehn, M.A., Principal investigator, Alliant International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187784
- Sponsor's protocol ID
- McNallyKeehn
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22588377
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive-Behavioral Therapy for Children With High-Functioning Autism Spectrum Disorder and Anxiety
- ClinicalTrials.gov ID
- NCT01187784
- Acronym / sponsor ID
- McNallyKeehn
- Conditions
- Autism Spectrum Disorder, Autism, Asperger Syndrome, PDD-NOS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alliant International UniversityUniversity, hospital or other
- Collaborators
- National Foundation for Autism Research, Autism Society of America - San Diego Chapter
- Study start
- May 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the current study is to evaluate the effectiveness of an empirically-supported, individually-based cognitive-behavioral treatment for anxiety disorders in children with autism spectrum disorder (ASD). Recent research suggests that 47 - 84% of children with ASD experience clinically significant levels of anxiety due to inhibited temperament, physiological hyperarousal, and distinct information processing biases. Despite the clear need for effective treatments for children with ASD and anxiety, there have been few empirical studies. However, a small body of literature has demonstrated growing support for the use of cognitive-behavioral therapy (CBT) to treat anxiety in children with high-functioning ASD. Kendall and Hedtke's Coping Cat cognitive-behavioral therapy program for anxious children will be utilized as the primary intervention. To date, there are no studies that have used this treatment program for anxiety in children with developmental disorders, including ASD. However, Coping Cat has been successfully adapted for children with a variety of co-occurring diagnoses (e.g., physical impairments, selective mutism). Participants in this study will be 20 children aged 7;0 to 14;11 years diagnosed with high-functioning ASD and at least one anxiety disorder (separation anxiety disorder, generalized anxiety disorder, or social phobia). A randomized controlled trial design will be employed. It is hypothesized that participants in the CBT condition will demonstrate a significantly larger reduction in overall levels of anxiety from pre-treatment to post-treatment compared to those in the waitlist (WL) condition and that children who complete the CBT treatment will maintain gains at two-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Active comparator | Behavioral: Coping Cat cognitive-behavioral therapy for anxious youthCoping Cat cognitive-behavioral therapy protocol |
| Waitlist Control | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 7 - 14 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
Key exclusion criteria (2 listed)
- IQ < 70
- Comorbid psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping Cat cognitive-behavioral therapy for anxious youthManualized, empirically supported CBT treatment for anxious youth | Behavioural | CBT |
Primary outcome
Anxiety Disorders Interview Schedule - Child/Parent Version
Time frame: Post Treatment (16 weeks)
Scores on parent-administered anxiety diagnostic interview after treatment or waitlist.
2 secondary outcomes
Multidimensional Anxiety Scale for Children
Time frame: Post Treatment (16 weeks)
Spence Children's Anxiety Scale (Child and Parent Versions)
Time frame: Post Treatment (16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
- Derived from this study: PubMed 22588377McNally 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca McNally Keehn, M.A. principal investigator
Alliant International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Coping Cat cognitive-behavioral therapy for anxious youth in people with Autism Spectrum Disorder and Autism, run by Alliant International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Disorders Interview Schedule - Child/Parent Version (time frame: Post Treatment (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01187784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2010.