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
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|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|
|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|
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.
Participants receive 16 weeks of BIACA therapy.
Active Comparator: Sertraline
These participants will receive 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.
Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.
- 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.
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
|Contact: Brianna Health, PH.D.||email@example.com|
|Contact: Erika Bickel, CCRPfirstname.lastname@example.org|
|United States, California|
|UC Davis MIND Institute||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Brianna Heath, PhD 916-703-0452 email@example.com|
|Principal Investigator: Marjorie Solomon, PhD|
|Principal Investigator:||Marjorie Solomon, PH.D.||UC Davis|