Study of anxiety treatments in Autism Spectrum Disorder (ASD)

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"Does therapy or medication better alleviate symptoms of anxiety and/or autism?"
8-12 years old
Healthy Volunteers:
Autism spectrum disorder, anxiety
We hope to learn more about anxiety as it uniquely manifests in autism spectrum disorder (ASD) and determine how best to alleviate anxiety in children with autism

Forty to eighty percent of children and preadolescents with autism spectrum disorder (ASD) exhibit clinically significant anxiety symptoms, which are associated with increased social deficits, depression, irritability, and stereotyped and self-injurious behaviors. While it is clear that anxiety symptoms represent a substantial problem for those with ASD, important issues that could inform treatment remain unresolved.

We seek to better characterize anxiety in autism and determine whether therapy or medication can better alleviate symptoms of anxiety and/or autism.
This study requires

Cognitive and anxiety testing MRI Eye tracking task Behavioral/clinical testing Questionnaires about your child Behavioral testing Standardized neuropsychological assessments Parent interview about your child’s development and anxiety symptoms (1-2 hours). Assessments and interview will be videotaped for scoring and reliability purposes to ensure consistency in data collection. If you agree to be videotaped, you reserve the right to review/edit the tapes. Cognitive-Behavioral Therapy (CBT) Medication (Sertraline & Pill Placebo) Medication log

At the end of treatment, your child will repeat the set of testing done at the beginning (MRI, eye tracking, and behavioral testing). This will be used to determine how the treatment phase impacted your child.

You will be asked to return three more times after the end assessment, at 4 week intervals. These visits will serve as check-ins to see how your child is doing after ending treatment. At the final visit, your child will do a third round of behavioral testing. This will be compared to the tests done at the end of treatment to determine whether the effects are lasting

Who can participate

Inclusion criteria: 1) Outpatient boys and girls with ASD between ages 8-12 years at consent. 2) Meets criteria for a diagnosis of ASD. 3) Meets criteria for clinically significant anxiety symptoms as defined by a minimum score of 14 on the PARS Severity Scale. 4) The child has a Full Scale and Verbal Comprehension IQ greater than 50 as assessed on the Wechsler Abbreviated Scales of Intelligence. 5) Subjects with co-morbid depression, tic disorder or disruptive behavior disorders will be acceptable as long as the anxiety symptoms are considered the primary mental health problem (i.e., most impairing/distressing). (a) Eligibility will be guided by the following principle: For subjects presenting with comorbid symptomology, the co-morbid conditions cannot be sufficiently severe to: 1) warrant immediate treatment or require a change in an otherwise stable psychosocial treatment regimen for that disorder, or 2) potentially interfere with the child's ability to comply with the study assessment and treatment batteries. (b) Preliminary determination of acceptable eligibility will be made by the PI with consultation with clinical co-Investigators on the project. (c) Finally, each potential subject will be presented and discussed at weekly team meetings. 6) The use of stable stimulant or alpha-agonist medications will be allowed if the dose has been consistent for 8 weeks and the family and treating psychiatrist affirm there is no plan to alter the dose or change medication in the foreseeable future.

Exclusion criteria: 1) Receiving concurrent psychotherapy, social skills training that include homework, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study. Other non-medication interventions will be allowed but we will document type and dose. This includes 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. Families of youth with ASD often have a variety of adjunctive services of this nature that they do not want to give up, and given the limited documentation of the efficacy of such interventions for social and emotional outcomes, it is deemed important to permit families to retain them in the service of recruiting a representative sample. If a potential participant is receiving non-allowed psychosocial treatments (psychotherapy, social skills training with homework, ABA) 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. In addition, we will obtain the patient‘s written consent to contact their treating clinician to determine the appropriateness of study participation. We will not influence the decision patients make with their clinician. If non-allowed psychosocial treatments are discontinued, Gate B assessments will not be conducted until 1 month following termination. 2) Child has failed a previous trial of sertraline judged adequate in dose (100mg/daily) and duration (at least 6 weeks) or child has a history of intolerance to sertraline. Subject has failed two previous SSRI (other than sertraline) trials judged adequate in dose (of 30mg/daily citalopram or paroxetine; 20mg/daily of escitalopram; 20mg/daily fluoxetine, 100mg/daily of fluvoxamine) and duration (6 weeks). 3) Biological Treatments: Recent treatment with psychotropic medication within 12 weeks of study entry for antidepressants and within 6 weeks for neuroleptics. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment. 4) Established Treatment changes: Any change in medication dosage (e.g., stimulant, alpha agonist) within 8 weeks before study enrollment will result in exclusion from the study. Any medications (e.g., stimulant) that the child is on must remain stable during treatment. If a potential participant is taking non-allowed psychotropic medication (antidepressants, antipsychotics) at the time of the phone evaluation and wishes to discontinue this medication to enter the study, the patient will be asked to discuss this option with their prescribing physician to determine whether medication discontinuation would be safe and in the child‘s best interest. In addition, we will obtain the patient‘s written consent to contact their treating clinician to determine the appropriateness of study participation. We will not influence the decision patients make with their prescribing physician. All pharmacotherapy recommendations will be made in consultation with Dr. Pakyurek. As described in Exclusion criterion 3, a specified waiting period would be required before the Gate B assessment should patients choose to discontinue non-allowed medications to enter the study. 5) 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. 6) Child has failed an adequate trial of CBT for anxiety 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 records review and speaking with the clinician if appropriate. 7) 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.). 8) Child has a major neurological disorder or medical illness that requires a prohibited episodic or chronic systemic medication or that would interfere with study participation (e.g., frequent hospitalizations, frequent school absences). 9) Child pregnancy as indicated by history or positive pregnancy test. 10) Inability to safely swallow study mediation after pill swallowing education. 11) Contraindications to MRI (i.e. claustrophobia, extreme sensitivity to noise, metal in the body). 12) Excess motion during scanning even after 2-3 training sessions.

Benefits and risks of participating
We cannot promise any benefits to you or your child from your taking part in this research. However, there are several potential benefits to participation in this study, including having comprehensive psychiatric and medical assessments and carefully-monitored treatment, at no cost to you. In addition, because both CBT and sertraline have been shown to be effective treatments for anxiety, there is a likelihood that your child’s anxiety symptoms will improve with these active study treatments, and as a result you may see improvement in their academic, social, and family functioning.

If your child is placed in the placebo group and does not respond during the treatment phase, you will be offered your choice of active study treatments (sertraline or CBT) for 16 weeks without charge. If your child shows improvement while in the placebo group, but relapses during the follow-up phase, you will also be given a choice of the alternate active treatments without charge.

We will also provide a written report of the results of your child’s performance on all standardized developmental, diagnostic, and behavioral procedures used in the study. Copies of structural MRI scans can also be provided to your child’s pediatrician for their medical record upon your request

Your child may have side effects while in this study. Everyone taking part in the study will be watched carefully for any side effects.

Therapy (CBT)
Increased anxiety and subjective distress may occur after beginning therapy. This is an appropriate and expected reaction to psychotherapies aimed at anxiety reduction. This effect is usually very transitory and mild, and is thought to be a result of the patient gradually stopping his or her avoidance of anxiety provoking situations while simultaneously allowing one‘s self to approach and/or think about these situations. If noted or described to the therapist (e.g., on CBT homework forms, during the course of discussion) and specifically described by you or your child as a negative effect of participation, the study team’s therapists can make certain adjustments to the pace or intensity of therapy (e.g., do a simpler exposure exercise; conduct further cognitive work before proceeding to exposure; do guided, therapist-assisted exposures) until our child is ready to or asks to approach the anxiety-provoking stimuli again.

Medication treatment
Side effects may be mild or serious. Most side effects go away soon after your child stops taking the study drug. Most children tolerate sertraline well and side effects are usually mild, transient, or can be controlled through dosage adjustment. You should talk to the research team about any side effects your child has while taking part in the study.

Risks and side effects related to the medication we are studying include:
• Gastrointestinal symptoms (nausea, cramps, diarrhea, lack of appetite)
• Central nervous system symptoms (increased motor activity, jitteriness)
• Insomnia
• Headaches
• Tremor
• Dizziness
• Dry mouth
• Weight loss
• Occasionally tiredness
• Some subjects become disinhibited demonstrating silliness or giddiness

This drug may cause a possibly life-threatening condition called serotonin syndrome. The symptoms of serotonin syndrome include hallucinations and delusions, agitation, coma, fast heart rate, and changes in blood pressure. They also include dizziness, loss of consciousness, seizures, shakiness, muscle tremor or stiff muscles, sweating, nausea, and vomiting.

Antidepressants may increase suicidal thoughts or actions in some children, teens or young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. People who have (or have a family history of) bipolar illness, or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. Sertraline has not been evaluated for use in patients under 18 for treatment of anxiety.
In the event of a moderate or severe adverse reaction to the medication, the medication will be reduced or withdrawn and clinical staff will follow your child closely until the adverse reaction remits. In the event of minor side effects (e.g., mild headaches), the medication may be maintained at the current dose levels or reduced.

FDA Warning Regarding Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of sertraline or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

To monitor your child for medication-related side effects, the study team will contact you weekly for the first 4 weeks of treatment, followed by bi-weekly check-ins thereafter. The research team is available 24 hours per day in the case of medical emergency or serious adverse events. If at any point in the treatment trial the treating clinician determines that a your child‘s symptoms have become sufficiently distressing or dangerous, your child will be withdrawn from the study and other treatments instituted.

No effect
You may see no improvement, or a worsening of symptoms. This may be due to your child not responding to treatment, or being part of the placebo group. If your child receives the placebo, you will be offered your choice of active study treatments (CBT or sertraline) for 16 weeks without charge. If your child’s symptoms worsen at any point during the study, contact the study team.

The only risks associated with MRI occur if your child has an existing contraindication to MRI. An example of a contraindication would be if your child had any type of metal implant. You will complete a standardized questionnaire to make certain that your child is not precluded from receiving an MRI scan due to existing contraindications and warnings

Some individuals experience feelings of anxiety or claustrophobia in an MRI environment. If this occurs, you or your child may ask to stop or pause the procedure at any time.

Medical information
If you tell your family doctor that you are participating in this study, or any specific aspects relating to your participation, this information may then become part of your medical record with this doctor. Insurance companies routinely have access to such records. We may need to obtain or release information to your doctor in order to ensure your child can safely participate in the study. This information cannot be released without your consent. You will be asked to authorize the sharing of this information, and the types of information shared will be explained to you beforehand.
You will be compensated with gift cards of $100 per visit for each of five planned assessment visits, including one qualification visit, one behavior assessment visit, and one scanning visit prior to treatment, and one behavioral assessment and one scanning visit post treatment.
Study duration and period
Treatment portion: 16 weeks. Follow-up: Visit every four weeks after the end of the treatment portion (12 weeks total). Total commitment: approximately 29 weeks or just over 7 months
Recruitment period
From Jan. 1, 2018
UC Davis MIND Institute
2825 50th Street
Sacramento, CA 95817
Stephanie Gam

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