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Specifying and Treating Anxiety in Autism Research (STAAR)

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ClinicalTrials.gov Identifier: NCT03279471
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:

Approximately 40%-80% of children and adolescents with autism spectrum disorder (ASD) exhibit clinically significant anxiety symptoms. These symptoms are associated with increased social deficits, depression, irritability, and stereotyped and self-injurious behaviors. Children and adolescents with anxiety also frequently avoid potentially stressful situations, thereby missing opportunities to learn important new skills. However, there is a lack of clarity about how to differentiate ASD and anxiety symptoms. There is also little known about how anxiety manifests in those with ASD and intellectual disability (ID). The goal of this study is to investigate these issues in order to make interventions more precise, more personalized, and more likely to promote positive outcomes

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. Multiple small trials have provided 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. In this study we will conduct a study in children with ASD and clinically significant anxiety ages 8-12 to compare efficacy of these different treatment types.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Anxiety Drug: Sertraline Behavioral: CBT/BIACA Drug: Placebo Phase 2

Detailed Description:

Approximately 40%-80% of children and adolescents with autism spectrum disorder (ASD) exhibit clinically significant anxiety symptoms. These symptoms are associated with increased social deficits, depression, irritability, and stereotyped and self-injurious behaviors. Children and adolescents with anxiety also frequently avoid potentially stressful situations, thereby missing opportunities to learn important new skills. Despite the significant consequences of anxiety symptoms, several critical treatment-relevant issues remain unresolved. First, there is a lack of clarity about how to differentiate ASD and anxiety symptoms. Second, little is known about how anxiety manifests in those with ASD and intellectual disability (ID). Third, the neural substrates of anxiety in ASD are poorly understood. The overarching goal of this project is to investigate these open issues in order to make interventions more precise, more personalized, and more likely to promote positive outcomes -- an objective consistent with the National Institutes of Health (NIH), the Roadmap, Precision Medicine, and Research Domain Criteria Project (RDoC) Initiatives and the Interagency Autism Coordinating Committee (IACC) Strategic Plan, Chapter 4.

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 leverage the large, well-characterized UC Davis MIND Institute Autism Phenome Project (APP) cohort to conduct a comparative efficacy trial in N=132 participants (ages 8-12 years) with ASD and clinically significant anxiety.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 Arm trial comparing manualized CBT/social skills training versus sertraline versus pill placebo
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: participants do not know what interventions others receive; med arm care providers don't know what interventions their patients receive; assessors don't know what treatments the participants they asses receive
Primary Purpose: Treatment
Official Title: Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : September 14, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: CBT/BIACA
Participants receive 16 weeks of BIACA therapy.
Active Comparator: Sertraline
These participants will receive sertraline
 Drug: Sertraline
Participants start at 12.5 mg and are increased by 12.5/day every two weeks for 14-16 weeks. Dosing is capped at minimum effective dose.
Placebo Comparator: Pill Placebo
These individuals will receive a pill placebo.
 Drug: Placebo
Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Pediatric Anxiety Rating Scale [ Time Frame: Change from 1 Weeks (pre-treatment) to 17 Weeks (treatment completion), and 29 Weeks (3 month post-treatment follow-up) ]
    The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The PARS will be used to assess both immediately pre- and post-treatment anxiety, as well as at a 3 month post-treatment follow-up.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Full Scale and 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. Contraindications to MRI (i.e. claustrophobia, extreme sensitivity to noise, metal in the body).
  11. Refusal to attempt MRI training or scanning session.
  12. Child and parent/caregiver who do not speak English.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279471


Contacts
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Contact: Brianna Health, PH.D. 916-703-0452 bheath@ucdavis.edu
Contact: Erika Bickel, CCRP 916-703-0389 esbickel@ucdavis.edu

Locations
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United States, California
UC Davis MIND Institute Recruiting
Sacramento, California, United States, 95817
Contact: Brianna Heath, PhD    916-703-0452    bheath@ucdavis.edu   
Principal Investigator: Marjorie Solomon, PhD         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Marjorie Solomon, PH.D. UC Davis
More Information
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Publications:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03279471    
Other Study ID Numbers: 1097281
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, Davis:
autism spectrum disorder
anxiety
cognitive behavior therapy
functional neuroimaging
Additional relevant MeSH terms:
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Anxiety Disorders
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Mental Disorders
Neurodevelopmental Disorders
Sertraline
Antidepressive Agents
 Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs