Study of anxiety treatments in Autism Spectrum Disorder (ASD)

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Have questions? Please contact the study coordinator at hs-STAARstudy@ucdavis.edu or call (916) 703-0119
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  1. *1. What is your child's first and last name?
  2. *2. Is your child between 8 -14 years old?
  3. *3. Which of the following best describes your child?
  4. *4. Does your child display symptoms of anxiety; fears, worries, or concerns that interfere with his/her life?
  5. *5. Since this is anxiety treatment study, are you open to your child receiving either therapy, medication, or pill placebo?
  6. *6. Are you willing to travel to the MIND Institute in Sacramento up to once a week for 16 weeks?
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"How can therapy or medication better alleviate symptoms of anxiety and/or autism?"
Age: 8-14 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Autism spectrum disorder, anxiety
Type: Other
Investigator:
Description
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

Pre-Treatment Visits 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).

Treatment VisitsYour child will be randomly assigned to a treatment of either: Cognitive-Behavioral Therapy (CBT) Medication (Sertraline OR Placebo)

Post-Treatment Visits 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.

Who can participate

Inclusion criteria:

Boys and girls with ASD between ages 8-14 years

Has or is suspected of having an autism spectrum disorder.

Has significant anxiety symptoms (does not need to have a formal clinical diagnosis of anxiety)

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 with the primary aim to treat the child's anxiety. Families will have the option of discontinuing such services to enroll in the study.

History of intolerance to sertraline or similar medications.

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

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

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
Benefit:
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 for your child

- Having carefully-monitored treatment, at no cost to you

- A likelihood that your child’s anxiety symptoms may improve with 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


Risk:
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.

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.

The most common 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

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.

MRI
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.
Compensation
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.
Resources
Schedule
Study duration and period
Pre-treatment: 3-4 half-day visits Treatment portion: 16 weeks with weekly or biweekly visits Follow-up: 2-3 half-day visits, four weeks after the end of the treatment portion Total commitment: approximately 29 weeks or just over 7 months
Recruitment period
From Jan. 1, 2018
Location
UC Davis MIND Institute
2825 50th Street
Sacramento, CA 95817

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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