Autism Spectrum DisorderPhase 2STAARNCT03279471
Specifying and Treating Anxiety in Autism Research
A Phase 2 study testing Sertraline and CBT/BIACA in people with Autism Spectrum Disorder and Anxiety, run by University of California, Davis at 1 site in United States.
Trial summary
In the Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study, we conducted a16-week randomized comparative treatment trial of the Behavioral Intervention for Anxiety in Children with Autism (BIACA), the medication sertraline, and placebo in youth with ASD ages 8-14 years old. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder, Anxiety
- What is being tested?
- Sertraline and CBT/BIACA
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 22 Feb 2023
- Phase
- Phase 2
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Outpatient boys and girls with ASD between ages 8-14 years at consent.
- Meets criteria for a diagnosis of ASD.
- Meets criteria for clinically significant anxiety symptoms as defined by a minimum score of 8 on the PARS Severity Scale.
- Meets criteria for clinically significant anxiety symptoms as defined by qualifying for diagnosis on 1 or more non-phobia items on the ADIS.
- The child has a Verbal Comprehension IQ greater than 50 as assessed on the Wechsler Abbreviated Scales of Intelligence or other standardized cognitive measure.
- Anxiety symptoms are considered the primary mental health problem (i.e., most impairing/distressing)
Show all 17Show fewer
- Stable medication regimen for 8 weeks prior to screening visit, including alternative medication, nutritionals, or therapeutic diets.
- Stable non-psychotherapy regimen for 4 weeks prior to screening visits. Non-psychotherapy regimen may include:
- Academic tutoring
- Occupational therapy
- Speech therapy
- School aides
- Stable psychosocial treatment regimen for 4 weeks prior to screening visits. Allowed psychosocial treatments may include:
- School counseling (no more than 60 minutes per week in duration)
- Psychotherapy
- Social skills training
- Applied behavior analysis (ABA) (up to 10 hours per week)
Who cannot join
- Subject is receiving significant concurrent psychosocial treatment with the primary aim to treat the child's anxiety.
- Families will have the option of discontinuing such services to enroll in the study. If a potential participant is receiving non-allowed treatments at the time of the phone evaluation and wishes to discontinue these treatments to enter the study, the patient will be asked to discuss this option with their clinician to determine whether termination would be safe and in the child's best interest. We will not influence the decision patients make with their clinician.
- History of intolerance to sertraline OR previous unsuccessful treatment with sertraline or other SSRIs judged adequate in dose (per list below) and taken for at least 6 weeks, within the past 12 months.
- Sertraline - 100mg/daily
- Citalopram or paroxetine - 30mg/daily
- Escitalopram - 20mg/daily
Show all 16Show fewer
- Fluoxetine - 20mg/daily
- Fluvoxamine - 100mg/daily
- Current clinically significant suicidal behaviors with intent or plan or individuals who have engaged in suicidal behaviors within 6 months. Study physicians will direct patient to appropriate clinical care if these behaviors are seen.
- Child has unsuccessful treatment for anxiety using a manualized CBT program within the previous 2 years (at least 10 sessions over a period of less than 1 year conducted by a licensed provider of CBT). This will be determined through parent report, records review and speaking with the clinician if appropriate.
- Lifetime DSM-5 bipolar disorder, schizophrenia or schizoaffective disorder as assessed by all forms of information (i.e., clinical history, data from the ADIS-IV, etc.).
- Abnormal laboratory or electrocardiogram results at screening that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject.
- Child has a major neurological disorder or medical illness that requires a prohibited episodic or chronic systemic medication that might interfere with the absorption, distribution, metabolism, or excretion of the study medication places the subject at increased risk, or that would interfere with study participation (e.g., frequent hospitalizations, frequent school absences).
- Child pregnancy as indicated by history or positive pregnancy test.
- Inability to safely swallow study medication after pill swallowing education.
- Child and parent/caregiver who do not speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis MIND Institute
Sacramento, California, 95817
About this study
Official title: Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder
In the Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study, we conducted a16-week randomized comparative treatment trial of the Behavioral Intervention for Anxiety in Children with Autism (BIACA), the medication sertraline, and placebo in youth with ASD ages 8-14 years old. The study involved 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab visits for safety testing, and 1-2 optional fMRI (functional magnetic resonance imaging) visits for participants before the pandemic made this impossible. The study provided 16-weeks of anxiety treatment involving weekly BIACA therapy either in-person or through telehealth, or medical check-up visits either at the UC Davis MIND Institute or via telehealth. After study completion a 3 month follow up call was conducted and participants in the placebo group were given the option to participate in an additional study phase with the study treatment of their choice. Study participation could be done remotely through the use of telehealth and local labs, meaning that visits to the University of California (UC) Davis MIND Institute were not required for most participants.
Several changes were made to the original protocol after the initiation of the COVID-19 Pandemic in mid-March of 2020. While the IRB of UCDMC deemed our study to be essential and permitted us to continue both psychosocial CBT therapy and medication administration, they required that:
- Assessment measures that had been implemented in person, be switched to online or Zoom administration.
- It also became impossible to administer the Autism Diagnostic Observation Scale (ADOS) in a valid manner. We then used the Childhood Autism Rating Scale (CARS-2) as the basis for qualification for the study.
- We were no longer able to see participants in person so Cognitive Behavior Therapy visits were moved to an online format.
- Similarly, medication visits were conducted over Zoom unless it was necessary to have the participant come into our clinic such as in the initial assessment or for safety concerns.
- In the Medication Arm, we partnered with Quest Labs to enable participants to receive their safety monitoring blood tests in the community.
- Unfortunately, it became extremely difficult to recruit patients willing to be scanned so we halted the fMRI component of the study.
Read the detailed description
Approximately 40%-80% of children and adolescents with autism spectrum disorder (ASD) exhibit clinically significant anxiety symptoms. These symptoms are associated with increased social deficits, depression, irritability, and stereotyped and self-injurious behaviors. Children and adolescents with anxiety also frequently avoid potentially stressful situations, thereby missing opportunities to learn important new skills. Despite the significant consequences of anxiety symptoms, what to do about this problem is less clear. The search for empirically-validated treatments has begun with multiple small trials providing promising evidence that selective serotonin reuptake inhibitors (SSRIs) and cognitive behavior therapy (CBT) might reduce anxiety in those with ASD. However, this work is in its early stages. There is a great need for large, rigorously designed trials that validate the effectiveness of both medication and CBT, as well as functional neuroimaging studies that identify neural predictors of treatment efficacy and markers of therapy-induced change. Such work holds the potential to help answer the questions posed above and to assist the field in developing more personalized treatments. In Project 1 of the Center for the Development of Phenotype-Based Treatments of Autism Spectrum Disorder, we conducted a study in children with ASD and clinically significant anxiety ages 8-14 to compare efficacy of these different treatment types.
More specifically, the overall aim of the study was to conduct a 16-week randomized comparative treatment trial of Behavioral Intervention for Anxiety in Children with Autism (BIACA), sertraline, and placebo in youth with ASD, IQ (intelligence quotient) >50, and clinically significant anxiety as assessed by a PARS score that is greater than or equal to 8. PARS is the primary outcome measures for the trial. Other prespecified measures such as clinician-administered gold standard assays will be used of traditional DSM (Diagnostic and Statistical Manual) [Pediatric Anxiety Rating Scale (PARS) and the Anxiety Disorders Interview Schedule-IV (ADIS-IV)], and nontraditional ASD related anxiety symptoms [Autism Spectrum Addendum to the ADIS (ASDD)] to qualify participants. We also used additional prespecified measures including parent reports of potentially overlapping symptoms that complicate the ASD anxiety phenotype. Although we additionally had wanted to include fMRI to investigate neural predictors of treatment efficacy, markers of treatment induced change, and signatures of anxiety sub-types, these efforts needed to be stopped due to the pandemic.
- Conditions
- Autism Spectrum Disorder, Anxiety
- Being tested
- Sertraline, CBT/BIACA, Placebo
- Keywords
- autism spectrum disorder, anxiety, cognitive behavior therapy, functional neuroimaging, STAAR, ASD, MIND Institute, UC Davis, MIND, University of California, Davis, autism
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Participants start at 12.5 mg and are increased by 12.5/day every two weeks for 14-16 weeks based on their tolerability to the medication. Dosing is capped at 125mg/day.
CBT/BIACABehavioural
Participants receive 16 weeks of BIACA therapy.
PlaceboDrug
Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.
| Study group | Role | What they receive |
|---|---|---|
| CBT/BIACA | Experimental | These participants will receive CBT treatment using Behavioral Interventions for Anxiety in Children with Autism (BIACA). BIACA is an anxiety treatment package designed for children with ASD that includes elements of CBT and social skills training. Receives: Behavioral: CBT/BIACA |
| Sertraline | Active comparator | These participants will receive sertraline Receives: Drug: Sertraline |
| Pill Placebo | Placebo comparator | These individuals will receive a pill placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Anxiety Rating Scale
The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week in 6 to 17 year olds. PARS is the one primary outcome measure used in this study. It is administered by a trained clinician who queries the participant's parent about anxiety symptoms experienced by the child and their associated severity and impairment over the past week. The first section is a Symptom Checklist with 50 items assessing 7 categories of anxiety symptoms on a 5-point scale. Given that some of these categories (number of symptoms and physical symptoms) don't directly bear on severity and/or may capture medication effects, they are not included in the final 5 Severity Score domains used in the overall calculation. Thus, scores on the PARS Severity Scale range from 0 to 25, with scores >14 consistent with clinically significant levels of anxiety in youth with ASD.
Measured: Change from baseline to week 17 (treatment completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Oct 2017
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
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 (9)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 Arm trial comparing manualized CBT/social skills training versus sertraline versus pill placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjorie Solomon, PH.D., Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279471
- Sponsor's protocol ID
- 1097281
- Acronym
- STAAR
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2017
- Last updated
- 23 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leyfer OT, Folstein SE, Bacalman S, Davis NO, Dinh E, Morgan J, Tager-Flusberg H, Lainhart JE. Comorbid psychiatric disorders in children with autism: interview development and rates of disorders. J Autism Dev Disord. 2006 Oct;36(7):849-61. doi: 10.1007/s10803-006-0123-0.
PubMed 16845581Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008 Aug;47(8):921-9. doi: 10.1097/CHI.0b013e318179964f.
PubMed 18645422van Steensel FJ, Bogels SM, Perrin S. Anxiety disorders in children and adolescents with autistic spectrum disorders: a meta-analysis. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17. doi: 10.1007/s10567-011-0097-0.
PubMed 21735077White SW, Oswald D, Ollendick T, Scahill L. Anxiety in children and adolescents with autism spectrum disorders. Clin Psychol Rev. 2009 Apr;29(3):216-29. doi: 10.1016/j.cpr.2009.01.003. Epub 2009 Jan 25.
PubMed 19223098Bishop-Fitzpatrick L, Mazefsky CA, Minshew NJ, Eack SM. The relationship between stress and social functioning in adults with autism spectrum disorder and without intellectual disability. Autism Res. 2015 Apr;8(2):164-73. doi: 10.1002/aur.1433. Epub 2014 Dec 19.
PubMed 25524571Gillott A, Furniss F, Walter A. Anxiety in high-functioning children with autism. Autism. 2001 Sep;5(3):277-86. doi: 10.1177/1362361301005003005.
PubMed 11708587Craske MG, Stein MB. Anxiety. Lancet. 2016 Dec 17;388(10063):3048-3059. doi: 10.1016/S0140-6736(16)30381-6. Epub 2016 Jun 24.
PubMed 27349358Vasa RA, Mazurek MO. An update on anxiety in youth with autism spectrum disorders. Curr Opin Psychiatry. 2015 Mar;28(2):83-90. doi: 10.1097/YCO.0000000000000133.
PubMed 25602249Sukhodolsky DG, Bloch MH, Panza KE, Reichow B. Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1341-50. doi: 10.1542/peds.2013-1193. Epub 2013 Oct 28.
PubMed 24167175
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03279471
- Acronym / sponsor ID
- STAAR / 1097281
- Conditions
- Autism Spectrum Disorder, Anxiety
- Keywords
- autism spectrum disorder, anxiety, cognitive behavior therapy, functional neuroimaging, STAAR, ASD, MIND Institute, UC Davis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Posted 23 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study, we conducted a16-week randomized comparative treatment trial of the Behavioral Intervention for Anxiety in Children with Autism (BIACA), the medication sertraline, and placebo in youth with ASD ages 8-14 years old. The study involved 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab visits for safety testing, and 1-2 optional fMRI (functional magnetic resonance imaging) visits for participants before the pandemic made this impossible. The study provided 16-weeks of anxiety treatment involving weekly BIACA therapy either in-person or through telehealth, or medical check-up visits either at the UC Davis MIND Institute or via telehealth. After study completion a 3 month follow up call was conducted and participants in the placebo group were given the option to participate in an additional study phase with the study treatment of their choice. Study participation could be done remotely through the use of telehealth and local labs, meaning that visits to the University of California (UC) Davis MIND Institute were not required for most participants.
Several changes were made to the original protocol after the initiation of the COVID-19 Pandemic in mid-March of 2020. While the IRB of UCDMC deemed our study to be essential and permitted us to continue both psychosocial CBT therapy and medication administration, they required that:
- Assessment measures that had been implemented in person, be switched to online or Zoom administration.
- It also became impossible to administer the Autism Diagnostic Observation Scale (ADOS) in a valid manner. We then used the Childhood Autism Rating Scale (CARS-2) as the basis for qualification for the study.
- We were no longer able to see participants in person so Cognitive Behavior Therapy visits were moved to an online format.
- Similarly, medication visits were conducted over Zoom unless it was necessary to have the participant come into our clinic such as in the initial assessment or for safety concerns.
- In the Medication Arm, we partnered with Quest Labs to enable participants to receive their safety monitoring blood tests in the community.
- Unfortunately, it became extremely difficult to recruit patients willing to be scanned so we halted the fMRI component of the study.
Detailed description
Approximately 40%-80% of children and adolescents with autism spectrum disorder (ASD) exhibit clinically significant anxiety symptoms. These symptoms are associated with increased social deficits, depression, irritability, and stereotyped and self-injurious behaviors. Children and adolescents with anxiety also frequently avoid potentially stressful situations, thereby missing opportunities to learn important new skills. Despite the significant consequences of anxiety symptoms, what to do about this problem is less clear. The search for empirically-validated treatments has begun with multiple small trials providing promising evidence that selective serotonin reuptake inhibitors (SSRIs) and cognitive behavior therapy (CBT) might reduce anxiety in those with ASD. However, this work is in its early stages. There is a great need for large, rigorously designed trials that validate the effectiveness of both medication and CBT, as well as functional neuroimaging studies that identify neural predictors of treatment efficacy and markers of therapy-induced change. Such work holds the potential to help answer the questions posed above and to assist the field in developing more personalized treatments. In Project 1 of the Center for the Development of Phenotype-Based Treatments of Autism Spectrum Disorder, we conducted a study in children with ASD and clinically significant anxiety ages 8-14 to compare efficacy of these different treatment types.
More specifically, the overall aim of the study was to conduct a 16-week randomized comparative treatment trial of Behavioral Intervention for Anxiety in Children with Autism (BIACA), sertraline, and placebo in youth with ASD, IQ (intelligence quotient) >50, and clinically significant anxiety as assessed by a PARS score that is greater than or equal to 8. PARS is the primary outcome measures for the trial. Other prespecified measures such as clinician-administered gold standard assays will be used of traditional DSM (Diagnostic and Statistical Manual) [Pediatric Anxiety Rating Scale (PARS) and the Anxiety Disorders Interview Schedule-IV (ADIS-IV)], and nontraditional ASD related anxiety symptoms [Autism Spectrum Addendum to the ADIS (ASDD)] to qualify participants. We also used additional prespecified measures including parent reports of potentially overlapping symptoms that complicate the ASD anxiety phenotype. Although we additionally had wanted to include fMRI to investigate neural predictors of treatment efficacy, markers of treatment induced change, and signatures of anxiety sub-types, these efforts needed to be stopped due to the pandemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 Arm trial comparing manualized CBT/social skills training versus sertraline versus pill placebo
| Arm | Type | Receives |
|---|---|---|
| CBT/BIACA | Experimental | Behavioral: CBT/BIACAThese participants will receive CBT treatment using Behavioral Interventions for Anxiety in Children with Autism (BIACA). BIACA is an anxiety treatment package designed for children with ASD that includes elements of CBT and social skills training. |
| Sertraline | Active comparator | Drug: SertralineThese participants will receive sertraline |
| Pill Placebo | Placebo comparator | Drug: PlaceboThese individuals will receive a pill placebo. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Outpatient boys and girls with ASD between ages 8-14 years at consent.
- Meets criteria for a diagnosis of ASD.
- Meets criteria for clinically significant anxiety symptoms as defined by a minimum score of 8 on the PARS Severity Scale.
- Meets criteria for clinically significant anxiety symptoms as defined by qualifying for diagnosis on 1 or more non-phobia items on the ADIS.
- The child has a Verbal Comprehension IQ greater than 50 as assessed on the Wechsler Abbreviated Scales of Intelligence or other standardized cognitive measure.
Key exclusion criteria (16 listed)
- Subject is receiving significant concurrent psychosocial treatment with the primary aim to treat the child's anxiety.
- History of intolerance to sertraline OR previous unsuccessful treatment with sertraline or other SSRIs judged adequate in dose (per list below) and taken for at least 6 weeks, within the past 12 months.
- Current clinically significant suicidal behaviors with intent or plan or individuals who have engaged in suicidal behaviors within 6 months. Study physicians will direct patient to appropriate clinical care if these behaviors are seen.
- Child has unsuccessful treatment for anxiety using a manualized CBT program within the previous 2 years (at least 10 sessions over a period of less than 1 year conducted by a licensed provider of CBT). This will be determined through parent report, records review and speaking with the clinician if appropriate.
- Lifetime DSM-5 bipolar disorder, schizophrenia or schizoaffective disorder as assessed by all forms of information (i.e., clinical history, data from the ADIS-IV, etc.).
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 |
|---|---|---|
| SertralineParticipants start at 12.5 mg and are increased by 12.5/day every two weeks for 14-16 weeks based on their tolerability to the medication. Dosing is capped at 125mg/day. | Drug | Sertraline |
| CBT/BIACAParticipants receive 16 weeks of BIACA therapy. | Behavioural | CBT/BIACA |
| PlaceboParticipants are given a placebo capsule with an administration schedule matching that of the sertraline subjects. | Drug | Pill Placebo |
Primary outcome
Change in Pediatric Anxiety Rating Scale
Time frame: Change from baseline to week 17 (treatment completion)
The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week in 6 to 17 year olds. PARS is the one primary outcome measure used in this study. It is administered by a trained clinician who queries the participant's parent about anxiety symptoms experienced by the child and their associated severity and impairment over the past week. The first section is a Symptom Checklist with 50 items assessing 7 categories of anxiety symptoms on a 5-point scale. Given that some of these categories (number of symptoms and physical symptoms) don't directly bear on severity and/or may capture medication effects, they are not included in the final 5 Severity Score domains used in the overall calculation. Thus, scores on the PARS Severity Scale range from 0 to 25, with scores >14 consistent with clinically significant levels of anxiety in youth with ASD.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16845581Leyfer OT, Folstein SE, Bacalman S, Davis NO, Dinh E, Morgan J, Tager-Flusberg H, Lainhart JE. Comorbid psychiatric disorders in children with autism: interview development and rates of disorders. J Autism Dev Disord. 2006 Oct;36(7):849-61. doi: 10.1007/s10803-006-0123-0.
- Background: PubMed 18645422Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008 Aug;47(8):921-9. doi: 10.1097/CHI.0b013e318179964f.
- Background: PubMed 21735077van Steensel FJ, Bogels SM, Perrin S. Anxiety disorders in children and adolescents with autistic spectrum disorders: a meta-analysis. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17. doi: 10.1007/s10567-011-0097-0.
- Background: PubMed 19223098White SW, Oswald D, Ollendick T, Scahill L. Anxiety in children and adolescents with autism spectrum disorders. Clin Psychol Rev. 2009 Apr;29(3):216-29. doi: 10.1016/j.cpr.2009.01.003. Epub 2009 Jan 25.
- Background: PubMed 25524571Bishop-Fitzpatrick L, Mazefsky CA, Minshew NJ, Eack SM. The relationship between stress and social functioning in adults with autism spectrum disorder and without intellectual disability. Autism Res. 2015 Apr;8(2):164-73. doi: 10.1002/aur.1433. Epub 2014 Dec 19.
- Background: PubMed 11708587Gillott A, Furniss F, Walter A. Anxiety in high-functioning children with autism. Autism. 2001 Sep;5(3):277-86. doi: 10.1177/1362361301005003005.
- Background: PubMed 27349358Craske MG, Stein MB. Anxiety. Lancet. 2016 Dec 17;388(10063):3048-3059. doi: 10.1016/S0140-6736(16)30381-6. Epub 2016 Jun 24.
- Background: PubMed 25602249Vasa RA, Mazurek MO. An update on anxiety in youth with autism spectrum disorders. Curr Opin Psychiatry. 2015 Mar;28(2):83-90. doi: 10.1097/YCO.0000000000000133.
- Background: PubMed 24167175Sukhodolsky DG, Bloch MH, Panza KE, Reichow B. Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1341-50. doi: 10.1542/peds.2013-1193. Epub 2013 Oct 28.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Marjorie Solomon, PH.D. principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sertraline and CBT/BIACA in people with Autism Spectrum Disorder and Anxiety, run by University of California, Davis 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 17 inclusion and 16 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 23 Sep 2026. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2026). 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 in Pediatric Anxiety Rating Scale (time frame: Change from baseline to week 17 (treatment completion)). 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 NCT03279471, which also lists 9 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 23 Sep 2026.