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


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:

Outpatient boys and girls with ASD between ages 8-12 years at consent.

Has a diagnosis of ASD

Has significant anxiety symptoms

IQ greater than 50 (assessed during study)

Stable medication regimen (no recent or planned significant changes).

Additional criteria may include co-morbid disorders, other medications, and other therapies. Our study team can discuss these criteria as they apply to your child.

Exclusion criteria:

Certain concurrent psychotherapy, social skills training, or behavioral interventions. Families will have the option of discontinuing such services to enroll in the study.

Child has history of intolerance to sertraline.

Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months.

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).

Inability to safely swallow study medication after pill swallowing education.

Contraindications to MRI (e.g., metal in the body).

Child and parent/caregiver who do not speak English.

Additional criteria may apply. Please contact us with any questions about the study or eligibility.

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.

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
Kellie Holley

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