Autism Spectrum DisordersTAASDNCT02028247
Psychotherapy for Anxiety in Children With Autism Spectrum Disorder
A study testing Personalized Cognitive-behavioral therapy, Standard Practice Cognitive-behavioral therapy and Treatment as Usual in people with Autism Spectrum Disorders and Autism, run by University of South Florida at 1 site in United States.
Trial summary
Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders, Autism, Asperger's Syndrome
- What is being tested?
- Personalized Cognitive-behavioral therapy, Standard Practice Cognitive-behavioral therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Outpatient boys and girls with ASD between the ages 7-13 years at consent/assent.
- The child meets criteria for ASD.
- The child meets criteria for clinically significant anxiety symptoms.
- The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70 as assessed on the Wechsler Intelligence Scale for Children-IV or another acceptable Intelligence Quotient test.
Who cannot join
- Receiving concurrent therapy targeting anxiety, social skills training with homework, or behavioral interventions (e.g., applied behavior analysis). This excludes academic tutoring, occupational therapy, speech therapy, school counseling that is no more than 60 minutes per week in duration, school aides, and social skills training groups that do not include homework and are no more than 60 minutes/week in duration.
- (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
- Child has been nonresponsive to an adequate trial of CBT for anxiety within the previous 2 years.
- Lifetime bipolar disorder, schizophrenia or schizoaffective disorder.
- Initiation of an antidepressant medication within 12 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 8 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Center for Neuropsychiatry, University of South Florida
St. Petersburg, Florida, 33701
About this study
Official title: 2/3 Treatment of Anxiety in Autism Spectrum Disorder
Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.
Read the detailed description
Autism spectrum disorders (ASD) are common neurodevelopmental syndromes affecting 1% of U.S. children. Comorbid anxiety disorders affect 40 to 50% of children with ASD, causing substantial distress and impairment over and above that caused by ASD alone. Although standard practice cognitive-behavioral therapy (CBT) has been established as an efficacious and safe treatment for anxiety disorders among typically developing youth, its utility in comorbid cases with ASD remains unknown. To date, no studies have experimentally compared standard practice CBT to a cognitive-behavioral intervention that has been personalized for children with a comorbid presentation of anxiety and ASD. Accordingly, we are proposing a randomized controlled trial to be conducted at three treatment sites to evaluate the efficacy of personalized CBT for anxiety in ASD (Behavioral Intervention for Anxiety in Children with Autism: BIACA) relative to standard practice CBT for anxiety (Coping Cat program). Furthermore, this study will employ a waitlist control group to assess the efficacy of each CBT arm relative to the absence of treatment (i.e., a Waitlist control arm). The proposed research will: (1) examine the efficacy of BIACA relative to Coping Cat, which represents standard practice treatment, and the efficacy of both these treatments relative to a waitlist control group, (2) evaluate the maintenance of treatment gains, (3) examine the impact of personalized intervention on functional outcomes. A total of 201youth across 3 study locations (ages 8-13 years) with ASD and co-occurring anxiety will be randomly assigned to one of the three conditions. The three recruitment sites for this study are University of California, Los Angeles, the University of South Florida (USF), and Temple University. Considering the rising number of children diagnosed with ASD together with the frequency and severity of comorbid anxiety, the proposed work is tailored to the unique needs of youth with ASD and will provide a timely contribution to public health efforts.
- Conditions
- Autism Spectrum Disorders, Autism, Asperger's Syndrome, Pervasive Developmental Disability - Not Otherwise Specified, Obsessive-compulsive Disorder, Social Phobia
- Being tested
- Personalized Cognitive-behavioral therapy, Standard Practice Cognitive-behavioral therapy, Treatment as Usual
- Keywords
- Autism spectrum disorders, Autism, Asperger's syndrome, Pervasive developmental disability - not otherwise specified, obsessive-compulsive disorder, Social phobia, Generalized anxiety disorder, Specific phobia, Separation anxiety disorder, Counseling, Cognitive-behavioral therapy, Psychotherapy
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome, Obsessive-Compulsive Disorder, Phobia, Social, Generalized Anxiety Disorder, Phobia, Specific, Anxiety, Separation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Cognitive-behavioral therapyBehavioural
Also called Behavioral Interventions for Anxiety in Children with Autism
Standard Practice Cognitive-behavioral therapyBehavioural
Also called Coping Cat
Treatment as UsualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Personalized Cognitive-behavioral therapy | Experimental | Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders. Receives: Behavioral: Personalized Cognitive-behavioral therapy |
| Standard Practice Cognitive-behavioral therapy | Active comparator | Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders. Receives: Behavioral: Standard Practice Cognitive-behavioral therapy |
| Treatment as Usual | Other | Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.
This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.
Measured: Baseline and After 16 Weeks of Treatment
Secondary outcomes (3)
Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale
The Clinical Global Impressions-Improvement scale (CGI-I) was completed by a clinician after 16 weeks of treatment. The CGI-I assesses the severity of anxiety on a 7 point scale, ranging from 1 (very much improved) to 7 (very much worse). A rating of 1 or 2 on the CGI-I designated a positive treatment response.
Measured: After 16 weeks of treatment
Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment.
The Child Behavior Checklist (CBCL) is completed by parents and the anxiety/depression subscale of the CBCL was used to assess anxiety/depression symptomatology. The CBCL anxiety/depression subscale is rated on a 3-point scale, ranging from 0 (Not true) to 2 (Very True), with higher scores indicating more symptoms.
Measured: Baseline and After 16 weeks of treatment
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
The Childhood Anxiety Impact Scale (CAIS) is a questionnaire completed by parents about the impact of the child's anxiety on functioning in three situational categories (i.e., school, social, and family functioning). The CAIS is rated on a 4-point scale, ranging from 0 (not at all) to 3 (very much). The CAIS items are summed and sorted into 3 subscales, corresponding to each situational category: school, social, and family. For all 3 subscales, higher scores correspond to more associated impact in that area.
Measured: Baseline and After 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, University of California, Los Angeles
- Responsible party
- Principal investigator, Eric Storch, Baylor College of Medicine
- Investigators
- Eric A Storch, Ph.D., Principal investigator, University of South FloridaJeff Wood, Ph.D., Principal investigator, University of California, Los AngelesPhilip C Kendall, Ph.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028247
- Sponsor's protocol ID
- NICHD CBT for ASD
- Acronym
- TAASD
- Status last verified
- Nov 2021
- First submitted
- 2 Jan 2014
- Last updated
- 15 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wood JJ, Rosenau KA, Muscatello V, Cooper K, Wood KS, Kendall PC, Storch EA. Cognitive Behavioral Therapy for Autistic School-Aged Children with Interfering Anxiety: Impact on Caregiver-Defined Goals. J Autism Dev Disord. 2025 May 8. doi: 10.1007/s10803-025-06852-6. Online ahead of print.
PubMed 40338510Storch EA, Wood JJ, Guzick AG, Small BJ, Kerns CM, Ordaz DL, Schneider SC, Kendall PC. Moderators of Response to Personalized and Standard Care Cognitive-Behavioral Therapy for Youth with Autism Spectrum Disorder and Comorbid Anxiety. J Autism Dev Disord. 2022 Feb;52(2):950-958. doi: 10.1007/s10803-021-05000-0. Epub 2021 Apr 7.
PubMed 33826038Wood JJ, Kendall PC, Wood KS, Kerns CM, Seltzer M, Small BJ, Lewin AB, Storch EA. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):474-483. doi: 10.1001/jamapsychiatry.2019.4160.
PubMed 31755906
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2/3 Treatment of Anxiety in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02028247
- Acronym / sponsor ID
- TAASD / NICHD CBT for ASD
- Conditions
- Autism Spectrum Disorders, Autism, Asperger's Syndrome, Pervasive Developmental Disability - Not Otherwise Specified, Obsessive-compulsive Disorder, Social Phobia
- Keywords
- Autism spectrum disorders, Autism, Asperger's syndrome, Pervasive developmental disability - not otherwise specified, obsessive-compulsive disorder, Social phobia, Generalized anxiety disorder, Specific phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Temple University, University of California, Los Angeles
- Study start
- Apr 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Posted 11 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.
Detailed description
Autism spectrum disorders (ASD) are common neurodevelopmental syndromes affecting 1% of U.S. children. Comorbid anxiety disorders affect 40 to 50% of children with ASD, causing substantial distress and impairment over and above that caused by ASD alone. Although standard practice cognitive-behavioral therapy (CBT) has been established as an efficacious and safe treatment for anxiety disorders among typically developing youth, its utility in comorbid cases with ASD remains unknown. To date, no studies have experimentally compared standard practice CBT to a cognitive-behavioral intervention that has been personalized for children with a comorbid presentation of anxiety and ASD. Accordingly, we are proposing a randomized controlled trial to be conducted at three treatment sites to evaluate the efficacy of personalized CBT for anxiety in ASD (Behavioral Intervention for Anxiety in Children with Autism: BIACA) relative to standard practice CBT for anxiety (Coping Cat program). Furthermore, this study will employ a waitlist control group to assess the efficacy of each CBT arm relative to the absence of treatment (i.e., a Waitlist control arm). The proposed research will: (1) examine the efficacy of BIACA relative to Coping Cat, which represents standard practice treatment, and the efficacy of both these treatments relative to a waitlist control group, (2) evaluate the maintenance of treatment gains, (3) examine the impact of personalized intervention on functional outcomes. A total of 201youth across 3 study locations (ages 8-13 years) with ASD and co-occurring anxiety will be randomly assigned to one of the three conditions. The three recruitment sites for this study are University of California, Los Angeles, the University of South Florida (USF), and Temple University. Considering the rising number of children diagnosed with ASD together with the frequency and severity of comorbid anxiety, the proposed work is tailored to the unique needs of youth with ASD and will provide a timely contribution to public health efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized Cognitive-behavioral therapy | Experimental | Behavioral: Personalized Cognitive-behavioral therapyPersonalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders. |
| Standard Practice Cognitive-behavioral therapy | Active comparator | Behavioral: Standard Practice Cognitive-behavioral therapyStandard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders. |
| Treatment as Usual | Other | Behavioral: Treatment as UsualParticipants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Outpatient boys and girls with ASD between the ages 7-13 years at consent/assent.
- The child meets criteria for ASD.
- The child meets criteria for clinically significant anxiety symptoms.
- The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70 as assessed on the Wechsler Intelligence Scale for Children-IV or another acceptable Intelligence Quotient test.
Key exclusion criteria (5 listed)
- Receiving concurrent therapy targeting anxiety, social skills training with homework, or behavioral interventions (e.g., applied behavior analysis). This excludes academic tutoring, occupational therapy, speech therapy, school counseling that is no more than 60 minutes per week in duration, school aides, and social skills training groups that do not include homework and are no more than 60 minutes/week in duration.
- (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
- Child has been nonresponsive to an adequate trial of CBT for anxiety within the previous 2 years.
- Lifetime bipolar disorder, schizophrenia or schizoaffective disorder.
- Initiation of an antidepressant medication within 12 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 8 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects).
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 |
|---|---|---|
| Personalized Cognitive-behavioral therapyAlso: Behavioral Interventions for Anxiety in Children with Autism | Behavioural | Personalized Cognitive-behavioral therapy |
| Standard Practice Cognitive-behavioral therapyAlso: Coping Cat | Behavioural | Standard Practice Cognitive-behavioral therapy |
| Treatment as Usual | Behavioural | Treatment as Usual |
Primary outcome
Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.
Time frame: Baseline and After 16 Weeks of Treatment
This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.
3 secondary outcomes
Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale
Time frame: After 16 weeks of treatment
Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment.
Time frame: Baseline and After 16 weeks of treatment
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
Time frame: Baseline and After 16 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40338510Wood JJ, Rosenau KA, Muscatello V, Cooper K, Wood KS, Kendall PC, Storch EA. Cognitive Behavioral Therapy for Autistic School-Aged Children with Interfering Anxiety: Impact on Caregiver-Defined Goals. J Autism Dev Disord. 2025 May 8. doi: 10.1007/s10803-025-06852-6. Online ahead of print.
- Derived from this study: PubMed 33826038Storch EA, Wood JJ, Guzick AG, Small BJ, Kerns CM, Ordaz DL, Schneider SC, Kendall PC. Moderators of Response to Personalized and Standard Care Cognitive-Behavioral Therapy for Youth with Autism Spectrum Disorder and Comorbid Anxiety. J Autism Dev Disord. 2022 Feb;52(2):950-958. doi: 10.1007/s10803-021-05000-0. Epub 2021 Apr 7.
- Derived from this study: PubMed 31755906Wood JJ, Kendall PC, Wood KS, Kerns CM, Seltzer M, Small BJ, Lewin AB, Storch EA. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):474-483. doi: 10.1001/jamapsychiatry.2019.4160.
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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.
Eric A Storch, Ph.D. principal investigator
University of South Florida
Jeff Wood, Ph.D. principal investigator
University of California, Los Angeles
Philip C Kendall, Ph.D. principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Cognitive-behavioral therapy, Standard Practice Cognitive-behavioral therapy and Treatment as Usual in people with Autism Spectrum Disorders and Autism, run by University of South Florida 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 4 inclusion and 5 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 15 Nov 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment. (time frame: Baseline and After 16 Weeks of Treatment). 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 NCT02028247, which also lists 3 linked publications.
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 15 Nov 2021.