Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2017-10-01
2023-02-22
Brief Summary
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Detailed Description
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While there is no doubt that anxiety is a very serious issue for those with ASD, what to do about this problem is less clear. The search for empirically-validated treatments has begun with multiple small trials providing promising evidence that selective serotonin reuptake inhibitors (SSRIs) and cognitive behavior therapy (CBT) might reduce anxiety in those with ASD. However, this work is in its early stages. There is a great need for large, rigorously designed trials that validate the effectiveness of both medication and CBT, as well as functional neuroimaging studies that identify neural predictors of treatment efficacy and markers of therapy-induced change. Such work holds the potential to help answer the questions posed above and to assist the field in developing more personalized treatments. In Project 1 of the Center for the Development of Phenotype-Based Treatments of Autism Spectrum Disorder, we will conduct a study in children with ASD and clinically significant anxiety ages 8-14 to compare efficacy of these different treatment types.
The overall aims of the study are to better characterize the sub-group of children and preadolescents with ASD that exhibit clinically significant anxiety and fears through a 16-week randomized comparative treatment trial of Behavioral Intervention for Anxiety in Children with Autism (BIACA), sertraline, and placebo in youth with ASD, IQ\>50, and clinically significant anxiety as assessed by a PARS score that is greater than or equal to 8. Clinician-administered gold standard assays will be used of traditional DSM (Pediatric Anxiety Rating Scale \[PARS\] and the Anxiety Disorders Interview Schedule-IV \[ADIS-IV\]), and nontraditional ASD related anxiety symptoms (Autism Spectrum Addendum to the ADIS \[ASDD\]), as well as parent reports of potentially overlapping symptoms that complicate the ASD anxiety phenotype. Additionally fMRI will be used to investigate neural predictors of treatment efficacy, markers of treatment induced change, and signatures of anxiety sub-types.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CBT/BIACA
These participants will receive CBT treatment using Behavioral Interventions for Anxiety in Children with Autism (BIACA). BIACA is an anxiety treatment package designed for children with ASD that includes elements of CBT and social skills training.
CBT/BIACA
Participants receive 16 weeks of BIACA therapy.
Sertraline
These participants will receive sertraline
Sertraline
Participants start at 12.5 mg and are increased by 12.5/day every two weeks for 14-16 weeks based on their tolerability to the medication. Dosing is capped at 125mg/day.
Pill Placebo
These individuals will receive a pill placebo.
Placebo
Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.
Interventions
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Sertraline
Participants start at 12.5 mg and are increased by 12.5/day every two weeks for 14-16 weeks based on their tolerability to the medication. Dosing is capped at 125mg/day.
CBT/BIACA
Participants receive 16 weeks of BIACA therapy.
Placebo
Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.
Eligibility Criteria
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Inclusion Criteria
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
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.
8 Years
14 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Marjorie Solomon, PH.D.
Role: PRINCIPAL_INVESTIGATOR
UC Davis
Locations
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UC Davis MIND Institute
Sacramento, California, United States
Countries
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References
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Leyfer OT, Folstein SE, Bacalman S, Davis NO, Dinh E, Morgan J, Tager-Flusberg H, Lainhart JE. Comorbid psychiatric disorders in children with autism: interview development and rates of disorders. J Autism Dev Disord. 2006 Oct;36(7):849-61. doi: 10.1007/s10803-006-0123-0.
Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008 Aug;47(8):921-9. doi: 10.1097/CHI.0b013e318179964f.
van Steensel FJ, Bogels SM, Perrin S. Anxiety disorders in children and adolescents with autistic spectrum disorders: a meta-analysis. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17. doi: 10.1007/s10567-011-0097-0.
White SW, Oswald D, Ollendick T, Scahill L. Anxiety in children and adolescents with autism spectrum disorders. Clin Psychol Rev. 2009 Apr;29(3):216-29. doi: 10.1016/j.cpr.2009.01.003. Epub 2009 Jan 25.
Bishop-Fitzpatrick L, Mazefsky CA, Minshew NJ, Eack SM. The relationship between stress and social functioning in adults with autism spectrum disorder and without intellectual disability. Autism Res. 2015 Apr;8(2):164-73. doi: 10.1002/aur.1433. Epub 2014 Dec 19.
Gillott A, Furniss F, Walter A. Anxiety in high-functioning children with autism. Autism. 2001 Sep;5(3):277-86. doi: 10.1177/1362361301005003005.
Craske MG, Stein MB. Anxiety. Lancet. 2016 Dec 17;388(10063):3048-3059. doi: 10.1016/S0140-6736(16)30381-6. Epub 2016 Jun 24.
Vasa RA, Mazurek MO. An update on anxiety in youth with autism spectrum disorders. Curr Opin Psychiatry. 2015 Mar;28(2):83-90. doi: 10.1097/YCO.0000000000000133.
Sukhodolsky DG, Bloch MH, Panza KE, Reichow B. Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1341-50. doi: 10.1542/peds.2013-1193. Epub 2013 Oct 28.
Related Links
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Learn more or sign up for the study here!
Other Identifiers
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1097281
Identifier Type: -
Identifier Source: org_study_id