Behavioral Interventions for Anxiety in Children with Autism (BIACA) for Autism, Early Infantile

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Westside Regional Center, Culver City, CA
Autism, Early Infantile+1 More
Behavioral Interventions for Anxiety in Children with Autism (BIACA) - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether cognitive behavioral therapy (CBT) is more effective than usual clinical care for children with autism and emotional dysregulation.

See full description

Eligible Conditions

  • Autism, Early Infantile

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Behavioral Interventions for Anxiety in Children with Autism (BIACA) will improve 1 primary outcome, 3 secondary outcomes, and 4 other outcomes in patients with Autism, Early Infantile. Measurement will happen over the course of Baseline [week 0] and Immediate Post-Treatment [approximately week 16].

Week 29
Change in Aberrant Behavior Checklist-2 Irritability Subscale (ABC-2)
Week 29
Change in Pediatric Anxiety Rating Scale (PARS)
Change in Social Responsiveness Scale II (SRS-II)
Week 16
Change in BIACA Therapist Quiz
Week 16
Consumer Satisfaction Parent Questionnaire
Mixed-methods feedback on training and consultation in BIACA
Therapy Procedures Checklist (TPC)
Week 15
Change in BIACA Fidelity Scales

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual Care Augmented by Self-Instruction Resources for CBT for Autism
1 of 2
Consultation-Based Training on BIACA
1 of 2
Active Control
Experimental Treatment

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Behavioral Interventions For Anxiety In Children With Autism (BIACA) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Consultation-Based Training on BIACA
Behavioral
Community mental health clinicians will be given online one-on-one training and consultation in the BIACA (Behavioral Interventions for Anxiety in Children with Autism; e.g., Wood et al., 2020) CBT program. Clinicians will be provided with weekly 30-minute video-conference-based consultation sessions with an expert in BIACA. These consultation sessions are manual-driven and utilize a Practice-Based Coaching format, in which a trained consultant meets weekly with clinicians to provide practice-based feedback (cf. McLeod et al., 2018). Consultation meetings include agenda setting, case material review, planning for the next treatment session, and a meeting summary. Relevant online training materials (e.g., demonstration videos of CBT sessions; corresponding written session materials) developed in the context of a NIMH R34 grant available on meya.ucla.edu (1R34MH110591) will also be provided to clinicians for each upcoming therapy session.
Usual Care Augmented by Self-Instruction Resources for CBT for Autism
Behavioral
Community mental health clinicians in this arm will provide any therapy, counseling, and/or behavioral treatment procedures they deem appropriate for each participating child. Clinicians randomized to this arm will be given immediate access to CBT-for-autism self-instruction materials that are already freely available to any clinician at meya.ucla.edu (see Consultation-Based Training on BIACA arm, above), to supplement their usual clinical care, if they so choose, until they complete their Usual Care/Self-Instruction participation and are offered direct training and weekly consultation in BIACA.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (week 0), session 4 (approximately week 4), session 8 (approx. week 8), session 12 (approx. week 12), immediate post-treatment [approx. week 16], and follow-up (approx. week 29)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline (week 0), session 4 (approximately week 4), session 8 (approx. week 8), session 12 (approx. week 12), immediate post-treatment [approx. week 16], and follow-up (approx. week 29) for reporting.

Who is running the study

Principal Investigator
J. J. W.
Prof. Jeffrey J. Wood, Professor
University of California, Los Angeles

Closest Location

Westside Regional Center - Culver City, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Some clinicians will work with youth who have ASD within recognized fields of practice and will serve referrals from participating agencies. show original
The referring agency pays for the treatment provided to the young person. show original
The study will include only youth who have been previously diagnosed with autism spectrum disorder by a qualified professional. show original
The parent-reported Social Responsive Scale-2 (SRS-2; Constantino & Gruber, 2012) Total T-Score will be greater than 60. show original
The subject has a high score on the Vineland Adaptive Behavior Scales-3 Communication Composite Standard Score, indicating that they are proficient in communication. show original
The young people in the study will meet the criteria for clinically significant emotion dysregulation symptoms if their score on the Aberrant Behavior Checklist-2 Irritability subscale is at least 18 show original

Patient Q&A Section

What causes autistic disorder?

"Though rare, congenital abnormalities and environmental exposures are plausible contributing factors. More research is required in order to confirm whether environmental factors are causative in autistic disorder and its subgroups." - Anonymous Online Contributor

Unverified Answer

Can autistic disorder be cured?

"Autistic disorder can be effectively treated with a combination of behavioral therapies (e.g., RIT, ACT, and DIR) within a supportive clinical group. Further prospective research is urgently needed to confirm this finding, given the potential for long-term public health benefits. Given the high rates of comorbidity in autistic disorder, further investigation into potential comorbid mood and anxiety symptoms is also warranted." - Anonymous Online Contributor

Unverified Answer

How many people get autistic disorder a year in the United States?

"Over 5.8 million children in the United States meet the criteria for autistic disorder and the prevalence continues to increase with age. The rates in females are double that in males and those diagnosed with autism do not live on the fringes of communities compared to autistic children of one or a low-income family status. Autism is a serious disability that can be a significant issue in the lives of a child's school and family members." - Anonymous Online Contributor

Unverified Answer

What are common treatments for autistic disorder?

"There continues to be little consensus on the best treatment approach for this pervasive developmental disorder. However, a great deal is known about the effects of stimulants and antipsychotic medication on children with ASD; thus, other treatment options continue to be under investigation. There also continues to be little evidence on the most effective treatment strategy for ASD." - Anonymous Online Contributor

Unverified Answer

What are the signs of autistic disorder?

"In a non-clinical sample of individuals with autism spectrum disorder signs of ADHD include: inconsistent performance on tasks that involve sustained attention/inhibition, the presence of hyperactivity/impulsivity, a consistently low or a very high total IQ, a discrepancy in average total IQ between genders, in general, a lack of social skills, and the absence of a speech language. Signs of ADHD include a preference for self-stimulation, impulsivity, poor eye-to-hand coordination, social skills, and lack of social skills." - Anonymous Online Contributor

Unverified Answer

What is autistic disorder?

"Autistic disorder is a rare neurodevelopmental disorder in adults characterized by impaired communication and social skills; a restricted and often restricted range of interests, with the breadth, persistence and intensity of such interests not varying significantly over time; and a restricted and often restricted range of repetitive or fixed behaviors. There is evidence for some degree of ASD in a significant number of people who present with intellectual disability. This article presents the diagnostic criteria for ASD. Further reading is suggested to better understand the complex nature of this disorder." - Anonymous Online Contributor

Unverified Answer

Has behavioral interventions for anxiety in children with autism (biaca) proven to be more effective than a placebo?

"Behavioral approaches are associated with larger and greater effects than the placebo on all measures, and it is suggested that the results are related to a greater degree of change than a placebo group would be able to achieve from a usual treatment. Behavioral approaches are not only useful with children with autism, but they also provide a general means of facilitating change in anxious children." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating autistic disorder?

"There have been many advancements in the treatment of ASD, although there is a lack of consensus on the best protocol for treatment of ASD. There have even been attempts of creating a single unified diagnostic guideline, but this method [of creating a single guideline] has not been 100% successful across the board (http://www.autism-awareness.org). There are many clinical trials that help us in developing more effective treatments, but we still need more in order to successfully treat individuals with ASD. Current treatments consist on medications, speech therapy, occupational therapy, behavior therapy, social communication and language, and instruction, but there is not any definitive treatment available for ASD (http://www.autism-research.net)." - Anonymous Online Contributor

Unverified Answer

What does behavioral interventions for anxiety in children with autism (biaca) usually treat?

"At present, there is very poor quality evidence regarding the effectiveness of behavioral interventions for children and young adults with ASD. There is very poor evidence for the effectiveness of pharmacological interventions and psychotherapy for children with ASD and high-functioning autism, but there is some support in the literature for behavioral interventions and behavior therapy (BIBT) for children with ASD with anxiety or depressive disorders." - Anonymous Online Contributor

Unverified Answer

What is behavioral interventions for anxiety in children with autism (biaca)?

"While the use of behavioral interventions for anxiety in children with autism is growing, there are few specific protocols. The findings from this study suggest that a biaca program is likely to be an effective approach to treating children's anxiety within an ASD clinic." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets autistic disorder?

"The age of onset of an ASD is often around 3–4 years of age, [though] [newer studies] suggest this average onset age may be around 2 years. What is the average duration of the disorder? At least for those who are diagnosed earlier, the disability and distress related to the disorder declines less quickly than previously thought. Patients can live longer without being disabled." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of behavioral interventions for anxiety in children with autism (biaca)?

"Based on our systematic search, most parents and pediatricians reported that medication was their preferred first line behavioral intervention, and the few reported medication first line was primarily due to convenience. Parents and pediatricians are encouraged to engage in ongoing discussion and collaborate to agree on the most appropriate behavioral treatment for children with autism through biaca." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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