A Phase 2 interventional study of Sertraline and CBT/BIACA in Autism Spectrum Disorder and Anxiety, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 8 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by University of California, Davis · Phase 2, Interventional, and Treatment
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Among 603 studies in Autistic Disorder with a site in United States — 123 open to participants now, 152 under way, 3 of them phase 3. Autistic Disorder · United States.
Among the 603 studies in Autistic Disorder with a site in United States, this one is the 175th largest by enrollment of the 504 interventional ones that give a count, is one of 18 that started in 2017, is one of 95 in phase 2, and was the 335th registered.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
Browse Autistic Disorder studies →123 of the 603 studies in Autistic Disorder with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 8–12
Vanderbilt University Medical Center · Sites in United States
Ages 36 mo–72 mo
University of Wisconsin, Madison · Sites in United States
Massachusetts General Hospital · Sites in United States
Ages 7–17
Stony Brook University · Sites in United States
Ages 12–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 183 Autistic Disorder studies recruiting now, 33 (18%) set no upper age limit and 143 (78%) stop at 75 or younger; 148 take children under 18; 56 take healthy volunteers.
This study: 8 Years to 14 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
603 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 55 · Phase 2 122 · Phase 3 43 · Phase 4 18
First in 1997; this study’s year is marked. 18 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 65 is above the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Median enrollment 44 across the 504 interventional studies, 135 across the 96 observational. Of the 408 that completed or were terminated, 143 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
73 of 603 have an industry lead sponsor. The 10 most frequent:
University of California, Davis is the lead sponsor of 810 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
University of California, Davis has 8 studies filed under Autistic Disorder — fewer than ten, so there is no comparison to draw.
34 of the studies in Autistic Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02914951Yale UniversityCognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability | 2026-12 |
| NCT06627205Stanford UniversitySleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism | 2026-12 |
| NCT04805957Rutgers, The State University of New JerseyValidation Digital Bio-markers During Sulforaphane Treatment. | 2026-12-01 |
| NCT07421830Northeastern UniversityAn Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism | 2026-12-31 |
| NCT02000284University of ArkansasMitochondrial Dysfunction in Autism Spectrum Disorder | 2026-12-31 |
Add all 34 to your calendar (.ics) → With an account.
Among the 603 studies in Autistic Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
This study's enrollment of 65 is above the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of California, Davis is the lead sponsor of 810 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stable non-psychotherapy regimen for 4 weeks prior to screening visits. Non-psychotherapy regimen may include:
Stable psychosocial treatment regimen for 4 weeks prior to screening visits. Allowed psychosocial treatments may include:
Exclusion criteria:
Subject is receiving significant concurrent psychosocial treatment with the primary aim to treat the child's anxiety.
a. 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: CBT/BIACA
These participants will receive sertraline
Drug: Sertraline
These individuals will receive a pill placebo.
Drug: Placebo
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.
Participants receive 16 weeks of BIACA therapy.
Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.
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.
Time frame: Change from baseline to week 17 (treatment completion)
| Milestone | CBT/BIACA | Sertraline | Pill Placebo |
|---|---|---|---|
| Started | 22 | 21 | 22 |
| Week 17 | 20 | 20 | 15 |
| Completed | 13 | 18 | 13 |
| Not completed | 9 | 3 | 9 |
| Withdrew: Protocol violation | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 4 | 1 | 1 |
| Withdrew: Withdrawal by subject | 3 | 2 | 5 |
| Withdrew: Adverse event | 1 | 0 | 2 |
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.
| score on a scale | CBT/BIACA | Sertraline | Pill Placebo |
|---|---|---|---|
| Change in Pediatric Anxiety Rating Scale | 11.1 ± 5.88 | 9.3 ± 5.27 | 14.06 ± 6.37 |
Collected over Adverse event data were collected per patient from treatment start date until final post-treatment follow-up (29 w weeks from treatment start) or until early termination from study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBT/BIACA | 0/22 (0%) | 0/22 (0%) | 7/22 (31.8%) |
| Sertraline | 0/21 (0%) | 0/21 (0%) | 18/21 (85.7%) |
| Pill Placebo | 0/22 (0%) | 0/22 (0%) | 17/22 (77.3%) |
| Event | CBT/BIACA | Sertraline | Pill Placebo |
|---|---|---|---|
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 3/22 | 3/21 | 7/22 |
| RashSkin and subcutaneous tissue disorders | 0/22 | 4/21 | 5/22 |
| FatigueGeneral disorders | 0/22 | 4/21 | 1/22 |
| HeadacheGeneral disorders | 1/22 | 4/21 | 3/22 |
| Sleep DisturbancePsychiatric disorders | 1/22 | 4/21 | 2/22 |
| Autism-Related BehaviorsPsychiatric disorders | 1/22 | 3/21 | 2/22 |
| ConstipationGastrointestinal disorders | 0/22 | 3/21 | 1/22 |
| VomitingGastrointestinal disorders | 0/22 | 3/21 | 1/22 |
| AnxietyPsychiatric disorders | 0/22 | 2/21 | 3/22 |
| Emotional LabilityPsychiatric disorders | 0/22 | 2/21 | 3/22 |
| Age, Continuous(years) | CBT/BIACA | Sertraline | Pill Placebo | Total |
|---|---|---|---|---|
| Mean | 10.74 ± 1.6 | 10.76 ± 1.66 | 10.3 ± 1.68 | 10.59 ± 1.62 |
| Sex: Female, Male(Participants) | CBT/BIACA | Sertraline | Pill Placebo | Total |
|---|---|---|---|---|
| Female | 3 | 3 | 5 | 11 |
| Male | 19 | 18 | 17 | 54 |
| Ethnicity (NIH/OMB)(Participants) | CBT/BIACA | Sertraline | Pill Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 8 | 6 | 17 |
| Not Hispanic or Latino | 16 | 13 | 13 | 42 |
| Unknown or Not Reported | 3 | 0 | 3 | 6 |
| Race (NIH/OMB)(Participants) | CBT/BIACA | Sertraline | Pill Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 2 | 2 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 0 | 4 |
| White | 11 | 11 | 16 | 38 |
| More than one race | 2 | 3 | 3 | 8 |
| Unknown or Not Reported | 4 | 3 | 2 | 9 |
| Region of Enrollment(participants) | CBT/BIACA | Sertraline | Pill Placebo | Total |
|---|---|---|---|---|
| United States | 22 | 21 | 22 | 65 |
| Pediatric Anxiety Rating Scale (PARS) Total Score(units on a scale) | CBT/BIACA | Sertraline | Pill Placebo | Total |
|---|---|---|---|---|
| Mean | 17.82 ± 3.91 | 16.76 ± 3.56 | 16.45 ± 3.62 | 17.27 ± 3.48 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Feb 2023, 64 months.
Results were first posted in Sep 2026, 3 years 7 months after primary completion.
Of 35 non-industry phase 2 interventional studies under Autistic Disorder, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's 64 months is above that.
Counting every sponsor, half of 44 studies reached it within 39 months; a quarter within 24 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of California, Davis →