Specifying and Treating Anxiety in Autism Research

• Status: Recruiting
• Trial end date: 2022-09-14
• Target enrollment: 0
• Participant gender: All

Summary

The Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study aims to better characterize the sub-group of children and preadolescents with ASD that exhibit clinically significant anxiety by conducting a 16-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 involves 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab visits for safety testing, and 1-2 optional fMRI visits. The study provides 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 is conducted and participants in the placebo group are given the option to participate in an additional study phase with the study treatment of their choice. Study participation can be done remotely through the use of telehealth and local labs, visits to the UC Davis MIND Institute are not required for most participants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Treatments: Sertraline

Criteria

Inclusion Criteria:

1. Outpatient boys and girls with ASD between ages 8-14 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 8 on the PARS Severity Scale.

4. Meets criteria for clinically significant anxiety symptoms as defined by qualifying for diagnosis on 1 or more non-phobia items on the ADIS.

5. The child has a Verbal Comprehension IQ greater than 50 as assessed on the Wechsler Abbreviated Scales of Intelligence or other standardized cognitive measure.

6. Anxiety symptoms are considered the primary mental health problem (i.e., most impairing/distressing)

7. Stable medication regimen for 8 weeks prior to screening visit, including alternative medication, nutritionals, or therapeutic diets.

8. Stable non-psychotherapy regimen for 4 weeks prior to screening visits. Non-psychotherapy regimen may include:

1. Academic tutoring

2. Occupational therapy

3. Speech therapy

4. School aides

9. Stable psychosocial treatment regimen for 4 weeks prior to screening visits. Allowed psychosocial treatments may include:

1. School counseling (no more than 60 minutes per week in duration)

2. Psychotherapy

3. Social skills training

4. Applied behavior analysis (ABA) (up to 10 hours per week)

Exclusion criteria:

1. 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.

2. 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.

1. Sertraline - 100mg/daily

2. Citalopram or paroxetine - 30mg/daily

3. Escitalopram - 20mg/daily

4. Fluoxetine - 20mg/daily

5. Fluvoxamine - 100mg/daily

3. Current clinically significant suicidal behaviors with intent or plan or individuals who have engaged in suicidal behaviors within 6 months. Study physicians will direct patient to appropriate clinical care if these behaviors are seen.

4. Child has unsuccessful treatment for anxiety using a manualized CBT program 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 parent report, records review and speaking with the clinician if appropriate.

5. 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.).

6. Abnormal laboratory or electrocardiogram results at screening that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject.

7. Child has a major neurological disorder or medical illness that requires a prohibited episodic or chronic systemic medication that might interfere with the absorption, distribution, metabolism, or excretion of the study medication places the subject at increased risk, or that would interfere with study participation (e.g., frequent hospitalizations, frequent school absences).

8. Child pregnancy as indicated by history or positive pregnancy test.

9. Inability to safely swallow study medication after pill swallowing education.

10. Child and parent/caregiver who do not speak English.