8-12 years old
Autism spectrum disorder, anxiety
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
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.
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