Effectiveness of Evidence-Based Mental Health Practices for Youth With Autism Supported by Online Consultation to Practitioners in Community and Navy Clinics
Phase: NA
Conditions: Autism
Sponsor: University of California, Los Angeles

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 1 
 
CBT for Youth with Autism and Emotional/Behavioral Needs in Community Care Settings 
(CYAN): Trial Protocol 
 
Investigators: Jeffrey J. Wood, Ph.D. (PI), Bryce D. McLeod, Ph.D. (Co-I), Michael Seltzer, 
Ph.D. (Co-I), Ari Zeldin, M.D. (Co-I), Kristofer A. Kazlauskas, M.D. (Co-I) 
 
Funding/Support: This research is supported by a grant from the Department of Defense Army 
Medical Research and Development Command (Award Number W81XWH-21-1-0334). 
 
Introduction:  
 
Clinically significant emotional dysregulation is common and impairing in school-aged youth 
with autism spectrum disorder (ASD) (e.g., Mazefsky et al., 2018; Samson et al., 2014). Emotion 
regulation problems place youth with ASD at increased risk for the development of emotional 
and behavioral disorders; for example, about 50% of all youth with ASD develop an anxiety 
disorder (e.g., Kirsch et al., 2020). Emotional dysregulation as manifest in symptoms of anxiety 
and irritability is linked with indices of increased functional impairments in youth with ASD 
such as greater social disengagement, involvement in bullying (as victim and as perpetrator), 
family conflict, and academic performance difficulties (e.g., Goldsmith & Kelley, 2018; Jahromi 
et al., 2013; Storch et al., 2012). Thus, a characteristic feature of ASD is difficulty with emotion 
regulation (Mazefsky et al., 2018). 
 
Emotional dysregulation is a common reason families seek mental health services for youth with 
ASD. Handling emotional dysregulation was cited as a reason for service needs by 77% of 
parents of youth with ASD in a recent survey (Hodgetts et al., 2015) and rated as parents’ first or 
second highest treatment priority for school-aged children with ASD (Brookman-Frazee et al., 
2012a; Kuravackel et al., 2014). Psychotherapy (defined as a client working with a trained 
clinician to understand and change feelings and behaviors and gain coping skills, generally in a 
one-on-one format in an outpatient setting; Wampold & Imel, 2015) is among the most 
frequently utilized mental health services by youth with ASD; for example, in a large-scale study 
of 28,009 youth with ASD, 46.5% of parents reported at least one psychotherapy visit in the past 
year (Stuart et al., 2017). In the 2011 Survey of Pathways to Diagnosis and Services of a 
nationally representative sample of 1,420 youth with ASD, parents reported that between 23% 
and 43% of the youth with ASD were currently receiving psychotherapy (Zablotsky et al., 2015). 
Thus, a substantial number of school-aged youth with ASD seek psychotherapy to address 
problems with emotion regulation. 
 
Improving the quality of care for school-aged youth with ASD presenting to psychotherapy with 
emotional dysregulation in community mental health centers (CMHCs) is a public health 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 2 
priority. Efficacious evidence-based treatments that address core ASD symptoms and emotional 
dysregulation are well developed (e.g., Wood et al., 2009a,b, 2015a, 2020). However, the quality 
of care (defined as the use of evidence-based treatments and improvements in clinical outcomes) 
in CMHCs where many school-aged youths with ASD receive psychotherapy is variable and 
typically not evidence-based (Christon et al., 2015; Pickard et al., 2018). Furthermore, few 
clinicians employed in CMHCs are aware of, or have access to, efficacious evidence-based 
treatments that target emotion regulation in school-aged youth with ASD, which contributes to 
the use of “off-label” medical and behavioral psychotherapies in CMHCs (Pickard et al., 2018). 
To remedy this problem, evidence-based treatments for school-aged youth with ASD and 
emotional regulation problems need to be implemented in outpatient CMHCs to evaluate 
effectiveness in real-world, everyday practice and to thereby take a necessary though not 
sufficient step towards improving the quality of care for you with ASD in CMHCs. The proposed 
project is intended to be an initial step towards addressing this need. 
 
Cognitive-behavioral therapy (CBT) has established efficacy for addressing core ASD symptoms 
and emotional dysregulation in school-aged youth (6-14 years old) with ASD (Weston et al., 
2016), but virtually no attention has been paid to evaluating the effectiveness of CBT in the 
settings where youth with ASD typically receive services: community and government facilities 
such as clinics and medical centers (Wood et al., 2015b). Instead, research has primarily been 
conducted in university-based research settings with strict eligibility criteria (i.e., efficacy 
studies). To date, these studies have established that CBT is efficacious for youth with ASD and 
can be delivered in a time-limited outpatient basis in contrast to in-home services (cf. discrete 
trial training; Wood et al., 2020). However, few youths with ASD will benefit from this research 
until the effectiveness of CBT programs for ASD is established in CMHCs (i.e., CBT programs 
demonstrate significant improvements in clinical outcomes relative to usual clinical care). And 
recent mental health effectiveness research in other populations (e.g., children with depression) 
has clearly demonstrated that some treatments become less potent when moved from the 
university setting to CMHCs (e.g., Sandler et al., 2019; Weisz et al., 2013), underscoring the 
need to utilize methods to support the successful implementation of CBT programs demonstrated 
to be effective in CMHCs (McLeod et al., 2018; Wood et al., 2015b). 
 
The primary objective of this project is to determine if CBT is effective relative to the usual 
clinical services provided to youth with ASD in the settings where they are most likely to receive 
mental health services – for example, federal government-funded medical centers serving 
families of members of the US Armed Forces (e.g., Naval Medical Centers serving Navy 
Exceptional Family Members such as youth with ASD with a parent in the Navy) or free/low-fee 
CMHCs supported by state government funding (e.g., state Regional Centers). The secondary 
objective is to investigate implementation factors (i.e., treatment integrity, feasibility, 
acceptability) that may affect the effectiveness of CBT delivered in CMHCs. We will evaluate 
the effectiveness of a CBT program for youth with ASD and emotion dysregulation that has 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 3 
demonstrated efficacy in research settings (Storch et al., 2013, 2015; Wood et al., 2009a,b, 
2015a, 2020), with training and implementation supports provided to CMHC clinicians in a 
format that is cost-efficient and feasible for future implementation: through a combination of 
consultation from a CBT expert via internet-based video conferencing as well as access to online 
resources (e.g., video demonstrations of CBT and corresponding written materials) that support 
treatment integrity across clinicians while reducing consultation and training costs. We propose 
an effectiveness-implementation hybrid design (i.e., Type I design; Curran et al., 2012) that will 
experimentally test the effectiveness of CBT and investigate implementation factors that might 
influence CBT effectiveness in CMHCs. We expect to enroll 100 youth with ASD who are 
referred for free or low-fee once-weekly therapy by their physician or case coordinator at a 
Naval Medical Center or state Regional Center, with a treatment emphasis on emotional 
dysregulation (e.g., anxiety, irritability) and interrelated autism symptom domains such as social 
initiation and responsiveness, and interfering repetitive behaviors. 
 
Background and Significance: 
 
Phenomenology and Course of Emotional Dysregulation in Youth with ASD. Youth with ASD 
often experience problems with emotion regulation. Descriptive research illustrates the numerous 
ways in which emotion dysregulation can manifest for youth with ASD (Mazefsky et al., 2018; 
Samson et al., 2014). Models of emotion regulation posit that mental processes can be used—
involuntarily or volitionally—to diminish, negate, increase, or transform emotional signals that 
arise in response to specific situations or perceptions (e.g., Gross, 2015). For example, walking 
into a dark room may trigger an appraisal of potential threat and a corresponding fearful 
emotional state that motivates fight/flight behaviors, but this feeling may be regulated by mental 
processes such as reappraisal (thinking of the situation in a way inconsistent with the initial 
appraisal and corresponding emotion) or suppression (inhibiting the behavioral manifestations of 
the feeling; e.g., Megias-Robles et al., 2019). Skillful emotion regulation varies as a trait among 
youth and is strongly linked with less externalizing and internalizing symptomatology in school-
aged youth (e.g., Aldao et al., 2016; Compas et al., 2017). In youth with ASD, common 
manifestations of poor emotion regulation include: (a) anxiety (e.g., a youth who fails to read 
aloud to her class out of fear of mistakes and humiliation, but experiences panic when compelled 
to do so), (b) excessive frustration (e.g., a youth who feels frustrated when producing imperfect 
work, who continuously writes, erases, and rewrites sentences that are appraised as insufficiently 
neat or descriptive), (c) sensory sensitivities (e.g., a youth who is distressed by the level of noise 
in a room and spontaneously shouts out for other to be quiet or runs out of the room), (d) sad and 
dysphoric mood (e.g., a youth who easily feels unappreciated, unworthy, or unhappy when faced 
with daily frustrations such as not being chosen first or receiving a mediocre test score), (e) 
irritability (e.g., a youth who becomes easily angry, defensive, or aggressive over minor 
provocations), or (f) impulsive goal seeking (e.g., a youth who is driven to engage in fun 
activities and in so doing ignores rules or others’ rights) (e.g., Cai et al., 2018; Conner et al., 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 4 
2020; Ozsivadjian et al., 2012; Pouw et al., 2013). These difficulties in emotion regulation in 
youth with ASD are directly related to challenges with functional outcomes such as peer 
relationships and academic success (e.g., Goldsmith & Kelley, 2018; Jahromi et al., 2013; Storch 
et al., 2012). 
 
Emotion dysregulation is strongly linked with morbidity in children, adolescents, and adults with 
ASD. Adaptive functioning in the domains of communication, socialization, daily living skills, 
and academic performance has been found to be severely compromised in the context of ASD 
throughout life, even for those with typical-range intellectual ability. For example, youth with 
ASD (even with IQ > 70) tend to score around the 1st to 4th percentile for their age and gender 
(i.e., 2 standard deviations or more below the 50th percentile on adaptive behavior scales), a 
trend that tends to worsen over the course of childhood (Pathak et al., 2017). As another 
example, in a study of 21-year olds with ASD who had IQ > 70, self-care skills were, on average, 
7 to 16 years behind chronological age norms (Bal et al., 2015). In young adulthood, even those 
with typical range intellectual functioning often exhibit severe adaptive challenges such as non 
daytime activities and high levels of reliance on support for employment and housing (e.g., 
Howlin & Moss, 2012; Tillmann et al., 2019). A significant contributing factor to this high 
morbidity in ASD, even in the context of typical range intellect and verbal ability, is concurrent 
emotion dysregulation (e.g., Chiang & Gau, 2016), as manifested in anxiety, irritability, and 
impulsivity, with correlations between indices of dysregulation and a composite adaptive 
functioning index ranging from .46 to .56 (Kraper et al., 2017). 
 
Emotion dysregulation is linked with higher autism symptom severity and is hypothesized to 
reciprocally exacerbate some of the underlying core aspects of ASD. For example, the low social 
motivation that typifies many children with ASD can lead to situational social withdrawal due to 
a lack of initiative in approaching others; this social withdrawal can be exacerbated by feelings 
of social anxiety and shyness that promote active avoidance and engender dysphoria in the 
presence of perceived social threats (Spain et al., 2018; Wood & Gadow, 2010). Heightened 
social withdrawal then leads to isolation in the peer group and a lack of peer conversation and 
friendship, amplifying or worsening these core ASD symptoms (cf. Dawson, 2008). Similarly, 
the dysregulated anger and frustration that often typify externalizing psychopathology can 
exacerbate ASD-related difficulties in social interactions and relationships (Shea et al., 2018). 
The development of both emotion regulation skills and social skills in an integrated treatment 
therefore has the potential to promote reciprocal progress in each domain as well as overall 
adaptive functioning. Complementarily, the rigid behaviors that typify aspects of the RRB 
domain (e.g., insistence on performing actions or engaging in routines one particular way) are 
likely driven by poorly regulated affect such as frustration and anxiety (rigid reactions to the 
possibility that deviations from expectations may either prevent reward/satisfaction, or increase 
the unknown and, thus, risk of punishment; Istvan et al., 2020; Samson et al., 2014). The 
phenotypic and psychometric resemblance of the RRBs with other manifestations of emotion 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 5 
dysregulation suggest that at least some aspects of the RRB constellation are products of poor 
emotion regulation and may be partially addressed in treatments targeting regulation in ASD 
(Istvan et al., 2020).  
 
Poor emotion regulation is a risk factor for youth with ASD that can lead to more impaired 
adaptive functioning and morbidity throughout childhood, adolescence, and adulthood. Poor 
emotion regulation increases the likelihood of developing emotional and behavioral disorders in 
the longer term, which is a significant risk factor for compromised functional and educational 
outcomes in individuals with ASD in adolescence and beyond. Improved emotion regulation is a 
critical target of treatment for many youths with ASD with likely implications for mental health 
outcomes as well as the core symptoms of ASD. 
 
Efficacious Treatments for Emotion Dysregulation in Youth with ASD. Cognitive behavioral 
therapy (CBT) has been found to be efficacious for emotional disorders and autism symptoms in 
youth with ASD in studies conducted in research settings (see Weston et al., 2016). A CBT 
program developed in our laboratory, Behavioral Interventions for Anxiety in Children with 
Autism (BIACA), has been evaluated and found efficacious for clinical anxiety and core ASD 
symptoms across research settings (i.e., university-based clinics) in 6 to 14 year-olds with ASD. 
Wood et al. (2009a,b) examined the efficacy of BIACA relative to a waitlist control (N = 40, 
ages 7-11). Youth randomized to BIACA had primary outcomes comparable to those found in 
CBT for typically developing anxious youth, with BIACA demonstrating superiority to waitlist 
in response rate (76.5% vs. 8.7%), clinical severity (d = 2.5), and Social Responsiveness Scale 
scores (d = .75; Wood et al., 2009a,b). We extended and replicated these findings in a study of 
BIACA that included observational ratings of peer interactions during recess (Fujii et al., 2013; 
Wood et al., 2014), and two studies of early adolescents with ASD (Ehrenreich-May et al., 2014; 
Wood et al., 2015). Storch et al. (2013; 2015) independently replicated our findings in two 
separate randomized controlled trials (RCTs). BIACA is the only CBT program for ASD that 
meets criteria as “efficacious” based on American Psychological Association Division 53 
Criteria (Southam-Gerow & Prinstein, 2014), based on its multiple successful replications by 
independent research groups and use of fully randomized designs at the youth level. BIACA is 
also unique in that it includes components to assist with social cognition and adaptive 
functioning (Drahota et al., 2011). Given that CBT has been efficacious in treating the anxiety of 
typically developing preschoolers (e.g. Hirshfeld-Becker et al., 2010), and that youth with ASD 
and intellectual disability have benefitted from gradual exposure to fearful stimuli (Koegel et al., 
2004; Luiselli, 1978; Luscre et al., 1996), another strength of BIACA is that Danial and Wood 
(under review) have successfully adapted this therapy for those with moderate levels of 
intellectual disability (IQ > 50). Other CBT programs for youth with ASD have yielded similar 
promising results, although these RCTs have tended to be small (e.g., DeRosier et al.,2011; 
Reaven et al., 2012). In short, in research settings, CBT has been established as an efficacious 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 6 
non-pharmacological treatment for emotion dysregulation and core autism symptoms in verbal 
youth with ASD (see meta-analysis conducted byWeston et al., 2016). 
 
In our NICHD-funded multi-site study recently published in JAMA Psychiatry (Wood et al., 
2020), impacts of BIACA were seen for emotion regulation and autism severity outcomes in 
comparison with a standard-of-practice CBT program. We recently completed a three-site RCT 
conducted at UCLA (PI: Wood), Baylor University (PI: Eric Storch), and Temple University (PI: 
Philip Kendall; R01-HD080098) in which 167 youth with ASD aged 7-13 years old were 
randomly assigned to BIACA, Coping Cat (a nonadapted CBT program for youth anxiety), or 
usual clinical care (Wood et al., 2020). The primary outcome measure was the Pediatric Anxiety 
Rating Scale, which is rated by an independent evaluator unaware of the child’s condition. 
Additionally, general measures of emotion regulation (the Child Behavior Checklist; CBCL) and 
core autism symptoms (the Social Responsiveness Scale-2; SRS) were administered to parents. 
BIACA outperformed Coping Cat and usual care on each measure. This study is noteworthy as it 
is the first major test of BIACA in comparison with another established, manualized evidence-
based CBT program. BIACA outperformed this treatment across each site, illustrating the 
specificity of its effects and the importance of designing CBT programs specifically for youth 
with ASD instead of relying on treatments developed exclusively with typically developing 
youth. 
 
Several features distinguish BIACA from non-ASD-specific treatments. The BIACA manual has 
been developed and revised over the course of years beginning with pilot work (e.g., Sze & 
Wood, 2007, 2008), clinician feedback, and ongoing experience implementing BIACA with 
youth with ASD. Drawing from standard CBT practices, cognitive restructuring(challenging 
irrational thoughts), perspective taking, exposure therapy (facing fears), antecedent management, 
self-management, modeling, and role-play are core strategies of BIACA. BIACA also includes 
design features that make the program accessible to youth with ASD. Youth motivation is 
emphasized using pivotal response features of youth choice and shared control, embedding 
special interests into treatment, and setting motivating conditions for engagement (e.g., operant 
procedures). The BIACA program incorporates parent and teacher consultation. BIACA is 
attuned to the social environment in which emotion dysregulation arises for many youth with 
ASD by providing compensatory social engagement skills that promote success when 
confronting emotionally provocative social situations (Wood et al., 2009a,b; Wood et al., 2011). 
BIACA is informed by evidence-based treatments well-established for youth with ASD (NAC, 
2015; NPDC, 2017) and has high treatment satisfaction among consumers (Wood et al., 2020). 
Although several other CBT programs have been developed for youth with ASD that have a 
narrower scope (e.g., focusing on anxiety), these are designed for group therapy(e.g., DeRosier et 
al., 2011; Kilburn et al., 2020) and none addresses the broad range of emotion regulation needs 
targeted in BIACA. 
 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 7 
Although CBT programs have demonstrated efficacy for emotional dysregulation and core 
autism symptoms in youth with ASD, research has yet to establish the effectiveness of CBT in 
CMHCs. At present, the quality of care (defined as the use of evidence-based treatments and 
improvements in clinical outcomes) for youth with ASD in CMHCs where many youths with 
ASD receive services is variable and typically not evidence-based (Christon et al., 2015; Pickard 
et al., 2018). As a first step in remedying this problem, the effectiveness of CBT for youth with 
ASD needs to be evaluated in CMHCs. 
 
Can CBT for Youth with ASD Be Effective in CMHCs? To date, work on therapy for youth with 
ASD has consisted of RCTs conducted under tightly controlled research conditions with limited 
attention to how, where (i.e., which settings), and by whom efficacious treatments are 
implemented. For example, the CBT studies conducted by Wood and others described above 
were all conducted in university settings. While this type of research (efficacy research) is an 
important step in determining the promise of a treatment, it does not necessarily foreshadow how 
successful the program might be in CMHCs (e.g., Kamio et al., 2015; Sandler et al., 2019). For 
example, CBT for anxiety in typically developing youth has found to be no more effective than 
usual care (Barrington et al., 2005; Southam-Gerow et al., 2010; Wergeland et al., 2014), and 
poor implementation of CBT by CMHCs clinicians may have accounted for these findings 
(McLeod et al., 2019; Smith et al., 2017). Also, a meta-analysis concluded that, although 
evidence-based treatments tend to outperform usual clinical care, the average effect was small (d 
= .29; Weisz et al., 2013), suggesting that a number of factors may undermine the effectiveness 
of evidence-based treatments for youth emotional and behavioral disorders in CMHCs. Given 
these gaps, research testing the effectiveness of promising treatments targeting emotion 
regulation for youth with ASD seeking treatment in CMHCs is an important first step towards 
improving the quality of care for youth with ASD in CMHCs. 
 
Little effectiveness research using stringent methodology has been conducted in the ASD field, 
and the small number of extant trials - none done on psychotherapy -offer a cautionary tale. 
Several effectiveness studies of early intervention programs for ASD based on applied behavior 
analysis (i.e., not psychotherapy) have produced positive gains for youth with ASD akin to those 
found in efficacy studies, but these studies tend to lack the methodological rigor of efficacy trials 
(i.e., no independently evaluated outcome measures, random assignment, and experimental 
control) so it is difficult to be confident in the findings (e.g., Cohen et al., 2006; Eldevik et al., 
2011). Most effectiveness trials of early intervention programs for ASD that have adhered to 
rigorous methodological standards have yielded outcomes that fall short of those obtained in 
research settings (see meta-analysis by Nahmias et al., 2019). To date, no known effectiveness 
trials of psychotherapy - one of the most common types of treatment used by school-aged youth 
with ASD (Stuart et al., 2017; Zablotsky et al., 2015) - have been undertaken. Taken together, 
these factors make it difficult to draw conclusions about the effectiveness of psychotherapy for 
youth with ASD being served in CMHCs. Moreover, the mixed results from the intensive early 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 8 
intervention studies suggest that there are likely barriers to implementing even treatments with 
promising efficacy data for ASD in community settings(Mandell et al., 2013; Nahmias et al., 
2019), which is consistent with findings from the broader youth mental health field (Weisz et al., 
2013). Based on these findings, there have been calls for alternative approaches to evaluating the 
effectiveness of evidence-based treatments for ASD that directly address potential 
implementation barriers (Kasari & Smith,2013; Wood et al., 2015). 
 
The high cost of treatment and the high clinical needs experienced by youth with ASD 
necessitate an empirically-informed special education, and related supports can exceed $50,000 
for youth with ASD (see review by Rogge & Janssen, 2019). Despite the cost entailed, the 
services provided to youth with ASD in CMHCs are often not evidence-based and outcomes for 
many youth are not optimal (e.g., Christon et al., 2015; Pickard et al., 2018). Relatively few 
mental health clinicians are trained to use evidence-based treatments such as CBT for ASD 
(Aiello et al., 2017; Combes et al., 2016; Sansosti & Sansosti, 2013). In a pilot study we 
conducted on clinicians’ use of evidence-based treatments for mental health challenges in youth 
with ASD (N = 52 clinicians), our interview and self-report data suggest that few clinicians have 
access to the training and consultation required to learn how to implement evidence-based 
treatments designed to address emotion regulation for school-aged youth with ASD, and that 
many practices used are not tied to the evidence base (Klebanoff & Wood, 2018). To remedy this 
problem, two steps are needed: 
 
1. First, we need to determine if evidence-based treatments that promote emotion regulation 
in youth with ASD are effective in CMHCs. CBT programs such as BIACA clearly have 
promise, demonstrated in multiple efficacy studies, to provide structure in the treatment 
for youth with ASD to significantly improve clinical care. 
 
2. Second, in conducting effectiveness research in this area, robust and field-tested clinician 
training and consultation procedures that can address barriers to implementation are 
needed. Inadequate clinician expertise and availability is a barrier to offering 
psychotherapy to those with psychiatric need (e.g., Fairburn & Patel, 2014). Research 
suggests that evidence-based treatments require sustained clinician training and 
consultation procedures for successful implementation in CMHCs (Schoenwald, 2012). 
However, if clinician training and consultation procedures are too costly, this could 
effectively exclude many community mental health settings and thus limit efforts to 
improve the quality of care for youth with ASD (Brookman-Frazee et al., 2012b; Wood et 
al., 2015b). Thus, efforts to evaluate the effectiveness of evidence-based treatments 
require effective clinician training and consultation procedures that support clinician 
mastery and expertise and are also cost-effective and scalable (e.g., McLeod et al., 2018; 
Schoenwald, 2012). 
 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 9 
Using A Distance Consultation Model to Address a Common Implementation Barrier. Efficient 
training and consultation methods are needed to ensure treatment models for ASD are acceptable 
and feasible for mental health clinicians in CMHCs (cf. Wood et al., 2015b). Contemporary 
training and consultation procedures can produce meaningful changes in clinicians’ delivery of 
evidence-based treatments in research settings (Herschell et al., 2010), including evidence-based 
treatments for youth with ASD (Stahmer et al., 2016). However, financial, geographic, and 
structural barriers make it difficult for clinicians treating youth with ASD to access the training 
and consultation opportunities needed for high quality implementation of evidence-based 
treatments (Brookman-Frazee et al., 2019; Maddox et al., 2020). Most training and consultation 
models rely on face-to-face contact, which limits the accessibility of evidence-based treatments 
in CMHCs. Thus, there is an emerging consensus that the internet represents a feasible and 
scalable platform for training clinicians and paraprofessionals (Fairburn et al., 2014; Neely et al., 
2018). We therefore will utilize an efficacious distance training and consultation model to 
support the implementation of BIACA in CMHCs, drawing from the successful Practice Based 
Coaching model used in previous BIACA trials. 
 
Practice-based coaching is an efficacious consultation method used in BIACA. The successful 
implementation of evidence-based treatments in CMHCs requires clinician training and 
consultation strategies that support treatment integrity (Hogue et al., 2013; McLeod et al., 2018). 
Defined as the quantity (i.e., treatment adherence, extent to which prescribed strategies of an 
evidence-based treatment are delivered) and quality (i.e., clinician competence, how well each 
prescribed strategy is delivered) of treatment delivery, achieving treatment integrity is key to 
implementation success (Proctor et al., 2011; Sutherland et al., 2018). Since research suggests 
that professional development in the form of one-time training does not result in proficient 
delivery of evidence-based treatments in CMHCs (Bearman et al., 2017; Becker & Domitrovich, 
2011; Sholomskas et al., 2005), BIACA uses a manualized Practice Based Coaching consultation 
model where a trained consultant meets weekly with a clinician to provide support in treatment 
delivery via practice-based feedback. This model is supported by a large literature that suggests 
that consultation strategies such as collaborative decision making, modeling, performance 
feedback, and opportunities to problem solve enhance and sustain clinicians’ delivery of 
treatment components (e.g.,McLeod et al., 2018; Reyes et al., 2012). Research suggests that 
practice-based coaching models result in increased adherence and competence of delivery 
beyond training alone, highlighting the importance of this approach for both increasing and 
maintaining treatment integrity (Sutherland et al., 2013, 2014). Moreover, integrity data from our 
BIACA studies suggest that our practice-based consultation model results in high integrity 
(Wood et al., 2009a, 2015a, 2020). Thus, the training and consultation model that is used in 
BIACA will address a common implementation barrier that can undermine the effectiveness of 
evidence-based treatments in CMHCs. 
 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 10 
In summary, CBT is well-suited to address poor emotion regulation among youth with ASD, yet 
barriers exist to implementing CBT for youth with ASD in CMHCs. The Practice Based 
Coaching model used in BIACA addresses one significant barrier–the need for effective training 
and consultation methods to ensure high quality care. Implementing this model via video 
conferencing in the present study will transform the Practice Based BIACA training and 
consultation model into an affordable and scalable method that could be utilized in future 
dissemination efforts should the proposed effectiveness study yield promising results. However, 
other potential implementation barriers may influence the effectiveness of CBT for youth with 
ASD in CMHCs, so we will employ an effectiveness-implementation Hybrid I design (see 
Curran et al., 2012) that will allow us to collect data on clinician- and client-level factors that 
influence BIACA’s effectiveness. 
 
Identifying Youth- and Clinician-Level Factors that Predict Treatment Response in CMHCs. To 
maximize the effectiveness of CBT for youth with ASD in CMHCs, more information about 
client and clinician factors that influence CBT outcomes in community settings is needed. To 
facilitate the transition of evidence-based treatments from effectiveness testing (does it work in 
community settings) to implementation research (what strategies are required to integrate a 
treatment into a community setting), researchers have proposed an innovative effectiveness-
implementation hybrid design (Curran et al., 2012), which allows for testing a treatment’s 
effectiveness while simultaneously collecting information on factors that influence effectiveness 
and its potential for implementation in CMHCs. The sole focus on clinical outcomes in 
effectiveness studies limits understanding of the factors that might influence implementation, for 
example, ensuring that a treatment is correctly deployed. A key feature of this study is the 
examination of how clinician-level (e.g., treatment integrity, acceptability, feasibility) and client-
level (e.g., verbal ability) factors influence the effectiveness of BIACA and may influence its 
potential for implementation and sustainment in CMHCs. 
 
Clinician-levels factors, such as mastery of core CBT strategies, are possible predictors of CBT 
effectiveness that represent key indicators to the uptake and sustainment of CBT. As noted 
above, for example, poor treatment integrity of CBT by CMHCs clinicians may have accounted 
for the underperformance of CBT versus usual clinical care in an effectiveness trial for youth 
anxiety in typically developing youth (McLeod et al., 2019; Smith et al., 2017). Poor treatment 
integrity indicates that the training and consultation procedures are not leading to mastery of core 
CBT strategies, which is important for positive youth outcomes (Hogue et al., 2008; Sutherland 
et al., 2018). Along with treatment integrity, other key indicators of CBT uptake and sustainment 
are important to assess during effectiveness evaluation (Proctor et al., 2011). Specifically, when 
initially introduced into a new setting, clinicians may react to a new program such as CBT either 
with resistance or with positive perceptions, so it is important to assess acceptability (i.e., 
perception that the treatment is agreeable, feasible, or satisfactory) and feasibility (i.e., extent to 
which a treatment can be successfully carried out in a particular setting). Information gathered 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 11 
about clinician-level factors that predict CBT effectiveness are important to identify so that 
specific strategies can be developed to support future adoption, effective delivery, and 
sustainment of CBT for youth ASD in CMHCs. 
 
Youth factors such as age and communication skills may also be linked with CBT effectiveness. 
Little is known about the potential similarities and differences in the youth with ASD who were 
treated in the efficacy trials and those who seek mental health services in CMHCs. Existing CBT 
programs have been designed for the youth with ASD seen in efficacy trials may thus not be an 
optimal fit for the youth in CMHCs. To ensure that CBT is a good fit for the clinical needs of 
youth with ASDseen in CMHCS we will evaluate whether a series of youth characteristics 
predict CBT effectiveness. Our selection of predictor variables is based on empirical precedent, 
theory, and logic. A number of RCTs for pediatric anxiety have found that older youth age 
predicts better treatment outcomes (see Skriner et al. 2019). Puleo and Kendall (2011) found that 
ASD symptom severity in typically developing youth predicted treatment response in standard 
CBT versus family-based CBT. A similar relationship is expected in the proposed trial. For 
example, greater ASD-related communication impairments may be a hindrance to optimal 
response to CBT due to impacts on comprehension and, hence, motivation. Although BIACA 
uses ASD-specific adaptations and collateral support to overcome communication challenges, it 
is possible that further modification may need to be made in order to optimize fit with youth with 
ASD in CMHCs. 
 
In summary, to help maximize the effectiveness of CBT for youth with ASD in CMHCs, it is 
critical to assess how client- and clinician-level factors influence implementation outcomes 
(Lewis & Simons, 2011; Palinkas et al., 2008)–do some clients benefit more from CBT than 
others? Do clinicians find the CBT program feasible, acceptable, and usable? What clinician 
factors most strongly predict youth outcomes (e.g., training engagement, CBT knowledge, 
integrity)? This information could help us develop implementation strategies that support the 
implementation of the BIACA program in CMHCs. 
 
 Specific Aims  
 
The specific aims of this study are:  
 
1. Aim 1. To compare the effectiveness of CBT and usual clinical care for addressing 
emotion dysregulation (e.g., irritability, anxiety) and core autism symptoms in youth with 
ASD who are referred for mental health treatment by their providers in Naval Medical 
Centers, state-funded Regional Centers, or California public schools.  
 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 12 
2. Aim 2. To characterize the mental health clinicians’ (e.g., psychologists’) level of 
engagement in online training and consultation, knowledge of CBT, perceptions of 
feasibility and acceptability, and treatment integrity.  
 
3. Aim 3. To examine how clinician-level factors (i.e., treatment integrity, feasibility, 
acceptability) and youth-level factors (e.g., age, communication ability) influence youth 
outcomes in the context of CBT delivered in community mental health centers in which 
training and consultation is provided via video conferencing. 
 
Research Plan: 
 
Overview. The proposed investigation is a randomized, controlled trial comparing CBT to usual 
clinical care for youth (aged 6-14 years) with ASD and emotional dysregulation (e.g., irritability, 
anxiety). We will randomly assign practitioners (at least 50) who address mental health needs in 
children with autism (e.g., therapists, counselors, speech/language pathologists, occupational 
therapists, psychologists, and behavior analysts), each treating up to 4 youth (N = 100 youth 
total), to (a) Consultation-Based Training on BIACA (referred to as “BIACA” below, for 
brevity) or (b) Usual Care Augmented by Self-Instruction Resources for CBT for Autism 
(referred to as “Usual Care/Self-Instruction” below), in a 1:1 allocation. The BIACA manual is 
well-supported in our efficacy research, has been replicated in other centers (Storch et al., 2013, 
2015), is free/open-access (meya.ucla.edu), and has user-friendly digital and traditional print 
materials for mental health clinicians (e.g., psychologists, counselors) to use in preparing for and 
conducting therapy sessions. The primary outcome measure will be assessed weekly. Additional 
assessments will occur at Screening, Mid-treatment, Post-treatment and 3-month Follow-up. 
 
Participant Enrollment. Participants will include 50 to 80 practitioners whose practice includes 
some clients with autism and emotional/behavioral needs whose clinical services (e.g., therapy, 
counseling) are paid for by the US military Tricare Health Program or the California public 
schools, or who are clients of the California Regional Centers; and 1 to 4 youth with ASD (ages 
6-14 years) and their parents per practitioner (for a total of 100 child and parent dyads). 
Practitioners will be encouraged to recruit 2 of the families they work with to participate with 
them, however, to accommodate varying capacity to recruit client families on the part of 
individual practitioners, a range of 1 to 4 client families per participating clinician will be 
permitted. 
 
Inclusion/Exclusion Criteria 
 
Clinician Inclusion Criteria:  
(1) All practitioner participants will regularly treat at least some youth with ASD within a 
recognized field of practice (e.g., clinical psychology, counseling, marital and family 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 13 
therapy, social work) and will serve youth with ASD referred by the Regional Centers, 
Tricare/NMCSD, or the California public schools.  
(2) Practitioners will agree to invite one or more potentially eligible families of youth with 
ASD so that at least 2 (and no more than 4) of the new families referred to them 
participate in the study (i.e., each clinician will aim to have a cluster of two families 
randomized to the same condition with them; however, the two referrals can be non-
parallel and clinicians will not be required to enroll a second client to remain in the study, 
since there is no way for them to guarantee future enrollment from client families. As 
needed, additional clinicians can be enrolled in the study to reach the target of 100 
youth.).  
 
Youth Inclusion Criteria:  
(1) Youth participants will be boys or girls between 6 and 14 years of age with a documented 
clinical diagnosis of ASD and will be newly referred for outpatient services with a 
participating clinician.  
(2) Youth will have a pre-existing clinical diagnosis of ASD made by an appropriate licensed 
professional (e.g., clinical psychologist, developmental pediatrician) which will be 
documented in a report or medical note provided by the family or confirmed 
telephonically by the diagnosing professional. 
(3) The parent-reported Social Responsive Scale-2 (SRS-2; Constantino & Gruber, 2012) 
Total T-Score will be > 60 (cut-score maximizing ROC curve parameters for screening 
for ASD; area under the curve = 98.8%; Schanding et al., 2011). 
(4) Youth will meet criteria for clinically significant emotion dysregulation symptoms as 
defined by a minimum T-score of 60 on the Externalizing or Internalizing subscales of 
the parent-reported Brief Problem Monitor (BPM) and at least 15 T-score points over 50 
between these two BPM subscales (e.g., Internalizing = 60 + Externalizing = 55). 
(5) The youth has a Vineland Adaptive Behavior Scales-3 Communication Composite 
Standard Score > 60 and Expressive Communication subscale v-score > 8 (in both cases 
> 1st percentile). 
 
Exclusion criteria. For youth participants presenting with severe comorbid symptomatology 
(e.g., psychotic symptoms), the comorbid conditions cannot be sufficiently severe to warrant 
immediate treatment or require ongoing medication titration. Current clinically significant 
suicidality at screening or youth who have engaged in suicidal behaviors within 6 months will be 
excluded and referred for appropriate clinical treatment.  
 
Screening Procedures 
 
Clinician Phone Screening: Potentially eligible direct providers (i.e., practitioner participants as 
described above) will respond to the introductory letter, flyer, email, web contact message, or 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 14 
phone call by contacting the project director at UCLA using the phone number provided in the 
letter. The clinician will be provided with information about the study, have questions answered, 
and, if interested in possibly participating, will be asked several screening questions and sent or 
emailed an IRB-approved clinician consent form in the mail (with a stamped, pre-addressed 
return envelope addressed to the project director. The clinician's consent form thoroughly 
describes the procedures to be followed in the study, the type of assessments involved, and the 
data that will be recorded (i.e., treatment sessions, consultation sessions, and Google Analytic 
data from the website). It will be emphasized that a decision to participate or not in the study will 
have no bearing on the clinician’s status with UCLA, NMCSD or Tricare, the Regional Centers, 
the California public schools or CAPTAIN. Mental health clinicians who continue to be 
interested in the study will have a second phone call with the project director to review the 
consent form and have any additional questions answered. During this phone call the research 
team will provide a full description of procedures to be followed and the type of assessments 
involved. Participants will also be informed at this point that all information they provide will be 
kept confidential to the fullest extent allowable by law. No information gathered as part of this 
research will be shared with agency directors or supervisors. Those who consent in writing to 
participate will be considered probably eligible for randomization when a family referred to them 
consents to participate, pending submission of their baseline measures.  
 
Youth Participant Screening Procedure: Participating mental health clinicians will be given a 
study recruitment flyer to share with potentially eligible parents of youth with ASD and 
emotion/behavioral target problems referred through the Tricare (US armed forces) health 
program or through the Regional Centers or via the California public schools. To avoid coercion 
of families, clinicians will be reminded not to use study enrollment as a condition for providing 
treatment, and to emphasize that not participating will not affect the family's access to care or 
relationship with the relevant institutions. The study flyer has contact information for the 
research team, enabling the family to contact the team directly should they wish to learn more 
about the study. Families will be reassured via written materials that choosing not to participate 
in the study will in no way affect their access to clinical care or relationship with their clinician, 
UCLA, Tricare, NMCSD, the Regional Centers, or the California public schools. All written 
study materials (e.g., flyers, consents, questionnaires) for families are available in both English 
and Spanish. 
 
Potentially interested families of youth with ASD will contact our project director. The project 
director will provide information about the study, provide a full description of procedures to be 
followed and the type of assessments involved, answer questions, conduct a brief screening and 
email or mail an IRB-approved written consent and assent forms for the parents and youth with a 
stamped, pre-addressed return envelope addressed to the project director if the family remains 
interested. The consent (parents) and assent (youth) forms thoroughly describe the procedures to 
be followed in the study, the type of assessments involved, and the data that will be recorded 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 15 
(i.e., treatment sessions). Families will be reassured by the project director that choosing not to 
participate in the study will in no way affect their access to clinical care or relationship with 
UCLA, Tricare, NMCSD, the Regional Centers, or the California public schools. Families who 
continue to be interested in the study will have a phone call with the project director to review 
the consent form (with the parent) and child assent form or teen assent form (with the child/teen 
and the parent) and have any additional questions answered. There will be no consequences for 
individuals who indicate interest and then do not enroll in the study. All participants will be free 
to withdraw their participation at any time of their choosing. Those who consent (parents) and 
assent (youth) in writing to participate will be considered potentially eligible for the study and 
proceed to Screening measures. 
 
-------------------- 
 
Screening Measures: Families who provide written consent and assent for study participation 
will receive Screening assessment materials (Brief Problem Monitor, Social Responsiveness 
Scale-2) either electronically via REDCap or in paper format; the Vineland Adaptive Behavior 
Scales-3 Communication Scales interview will be administered over the phone.  
 
Baseline measures: Eligible families, mental health clinicians, and teachers will complete the 
Baseline measures (see Assessment and Measures below) prior to randomization. 
 
Treatment Conditions 
 
Randomization. A cluster-randomized design will be implemented (clients nested within mental 
health clinicians); thus, the unit of randomization will be at the clinician level. Eligible mental 
health clinicians will be randomized to the BIACA arm or the Usual Care/Self-Instruction arm in 
a 1:1 ratio. Randomization will be computer-generated at VCU using the stratification and 
randomization procedure developed at UCLA and will stratify on (a) site and (b) mental health 
clinicians’ years of experience treating youth with ASD (< 2 years or > 2 years). The 
stratification plan will allow for enrollment across the three sites to accrue on a first-come-first-
serve basis in order to ensure that the sample is broadly representative of each site (as opposed to 
arbitrarily turning potential participants away at a site because their "quota" for the year has been 
met). It is unclear what ratio of more experienced to less experienced clinicians are practicing at 
these sites. Therefore, stratification efforts will aim to maintain the same ratio of practitioners 
from the three sites in the two arms (BIACA and Usual Care/Self-Instruction; i.e., a 1:1 ratio at 
each site) and to maintain the same ratio of more experienced and less experienced practitioners 
in the two arms at each site. Randomization status will not be revealed to independent evaluators 
(IEs) or the statistician. Advanced graduate trainees who have been approved by the IRB to work 
on the study and trained to research reliability to administer the study assessments will serve as 
IEs. 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 16 
 
Consultation-Based Training on BIACA. In the BIACA program (Wood et al., 2009b), clinicians 
work with families for 16 weekly sessions, each lasting up to 60 minutes (30 minutes with the 
youth and 30 minutes with the family/parents). The BIACA approach has expanded traditional 
anxiety-focused CBT and irritability-focused parent-training models to include the ASD-related 
clinical characteristics (e.g., social withdrawal, inflexibility) that are closely related to anxiety 
and irritability and often are the initial referral focus in ASD. Youth with ASD and significant 
emotional dysregulation are doubly impacted: they have core social deficits related to ASD (e.g., 
impaired conversation initiation and maintenance) as well as debilitating emotional 
reactivity/dysregulation that is associated with further social maladjustment in ASD. The BIACA 
manual includes 4 emotion coping skills training modules. Anxiety, rigidity and inflexible 
routines, and stimuli that trigger frustration and irritability are all addressed using in vivo 
exposure therapy strategies (in some cases with response prevention; i.e., the client planning to 
suppress a strong emotional reaction) during sessions. Friendship skills, social entry skills (e.g., 
joining games at school), and reciprocal conversation skills are addressed with modeling, self-
management, and parent- (or teacher-) implemented social coaching in daily settings. 
Therapeutic concepts are taught to youth using modeling, guided discussion,drawing/cartooning, 
writing (e.g., “thought bubbles''), role playing, and Socratic questioning. In-session reward and 
youth-choice principles are used to enhance the alliance and motivation to participate in therapy 
procedures. Behavioral parent training elements are emphasized in most sessions to help 
motivate youth towards treatment goals at home and in the community and to reduce unintended 
reinforcement of target symptoms (key parent-mediated evidence-based strategies include 
contingency management, extinction, antecedent management and “special play time”, and 
participation in home-based exposure and response prevention practice). The CBT program is 
flexible and employs a partially modular format guided by a treatment algorithm designed to 
emphasize clinical components addressing each youth¿s most pressing/severe emotional 
dysregulation and ASD symptoms. For youth with Vineland-3 Communication Standard Scores 
>60 and <70,therapy is adapted through the use of toy and play-based representations of 
challenging situations for the coping skills training phase, simplified mantras for cognitive 
restructuring, and more action-oriented rehearsal and exposure work instead of verbally mediated 
preparation for exposure (Danial & Wood, under review). 
 
Clinician training and consultation: All mental health clinician training and consultation will be 
conducted remotely online. Online training materials (e.g., demonstration videos of CBT 
sessions; corresponding written session materials) have been developed in the context of a 
NIMH R34 grant awarded to Drs. Wood and McLeod (available on meya.ucla.edu; 
1R34MH110591).  
 
In addition to ongoing access to these online training and clinical resources for BIACA, mental 
health clinicians will be provided with weekly 30-minute video-conference-based consultation 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 17 
sessions with an expert in BIACA (Dr. Sze-Wood) to provide a professional but cost-effective 
means of developing expertise in BIACA. These consultation sessions are manual-driven and 
utilize a Practice-Based Coaching format, in which a trained consultant (in this case, Dr. Sze-
Wood) meets weekly with clinicians to provide practice-based feedback (cf. McLeod et al., 
2018). The core premise of Practice-Based Coaching is that in order to promote long-term 
learning, consultation must help clinicians further develop procedural knowledge along with the 
metacognitive skills required to apply that knowledge and skills to novel situations (Bennett-
Levy, 2006; Falender &Shafranske, 2014). In our BIACA Practice Based Coaching model, 
consultation meetings include agenda setting, case material review, planning for the next 
treatment session, and a meeting summary. Within this structure, two core active strategies are 
embedded (McLeod et al., 2018; Rakovshik et al., 2016; Sholomaskas et al., 2005): (a) 
behavioral rehearsal of the core therapeutic strategies found in BIACA and (b) cognitive 
rehearsal in which the case formulation for a client is discussed and applied to the particular 
circumstances of the client. Across BIACA consultation meetings, the delivery of these active 
strategies is guided by three principles from adult learning theory (Rakovshik & McManus, 
2010; Soderstrom & Bjork, 2015): (a) Variability and distribution of practice¿this principle 
involves having clinicians engage in the skill- and cognitive-based tasks across different 
conditions (e.g., asking a clinician to formulate a case conceptualization based on a child with 
ASD, with or without conduct problems), over time (i.e., rehearsal of specific skills is spread 
over weeks), and with multiple clients (Jackson et al., 2017). The BIACA consultation manual 
focuses on a single set of therapeutic strategies each week related to the content of the BIACA 
manual to be delivered next; however, massed practice (i.e., intense practice of the same skill in 
a single meeting) does not promote long-term learning (Soderstrom & Bjork, 2015). To optimize 
long-term learning, cognitive and behavioral rehearsals related to varying BIACA strategies 
(e.g., exposure, reward, self-management) are spread across multiple consultation sessions. (b) 
Retrieval practice: this principle involves asking clinicians to demonstrate core cognitive- and 
skill-based tasks in different conditions to help promote long-term learning. Research indicates 
that prompting trainee knowledge retrieval over time helps to solidify learning gains and 
promote long-term learning(Soderstrom & Bjork, 2015). (c) Difficult cognitive- and skill-based 
practice: this principle involves posing “what if” questions regarding complex clinical situations 
in cognitive rehearsals and engaging clinicians in challenging behavioral rehearsals (e.g., by 
varying the level of difficulty of the client) to help with skill acquisition and the development of 
active encoding processes (McLeod et al., 2018). Treatment integrity data from our BIACA 
studies suggest that our practice-based consultation model results in high clinician fidelity 
(Wood et al., 2009a, 2015a, 2020). 
 
Although clinicians in this treatment arm will be encouraged to apply CBT/BIACA techniques 
where appropriate, ultimately decisions on what therapy topics and practices are used throughout 
treatment are their own, and there will be no pressure or consequences of any sort for clinicians 
who choose to utilize therapeutic strategies that differ from those discussed in the consultation 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 18 
meetings. Rather, the consultation meetings will continue on as per schedule, with the clinician 
and consultant discussing therapeutic options in a collegial way throughout the study. 
 
Usual Care Augmented by Self-Instruction Resources for CBT for Autism. Youth in this arm will 
receive any therapy, counseling, and/or behavioral treatment that is normally provided by their 
mental health clinician. However, this arm will also be congruent with DoD guidance (FY20-
ARP-GAI-1.pdf) stating, "Studies designed in a manner that permits all subjects to potentially 
benefit directly from medical treatment or enhanced surveillance beyond the standard of care can 
meet the 10 USC 980 requirements." Because of this requirement, therapists randomized to the 
Usual Care/Self-Instruction arm with at least one client participating will be informed that they 
have immediate access to CBT-for-autism self-instruction materials that are already freely 
available to any clinician at meya.ucla.edu, 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. While self-instruction in any psychotherapy 
approach often has only modest effects on the practices of many clinicians, making clinicians 
aware of a training resource they already had free access to (but may have been unaware of) 
offers an authentic means for therapists to improve upon the standard of care while still 
maintaining the critical element of a usual care condition, which is the therapist's autonomy in 
selecting any treatment approach they view as most suitable. The BIACA observational 
measurement tools (see below) will be used to characterize the overlap and differences between 
UsualCare/Self-Instruction and BIACA. Mental health clinicians randomized to Usual Care/Self-
Instruction will be offered training and consultation on BIACA specific to the youth enrolled in 
the study (if they are still in treatment) after the follow-up measures have been collected. 
Families will be free to accept or decline ongoing treatment from the mental health clinician, or 
to begin any other clinical service they wish, throughout the Usual Care/Self-Instruction arm. To 
document the overall set of clinical services sought during the study by each family throughout 
the acute phase, the Services Assessment for Children and Adolescents will be administered to 
parents by the IE at Pre- and Post-Treatment (see Assessment Measures, below). 
 
Assessments and Measures 
 
Assessment measures were selected to address the critical need to avoid participant burnout in 
effectiveness research. First,we took the approach of beginning with identification of primary 
outcomes variables, measures needed to assess eligibility, and only then considering the most 
salient secondary outcome variables or possible predictors. Second, we focused on convenience. 
If two measures had an equally good psychometric rationale for use in the study but there was 
greater convenience and efficiency for the participant in one of the measures (e.g., shorter to 
complete, easier to understand, superior accessibility via electronic entry options), then the more 
convenient and efficient measure was chosen.  
 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 19 
Measures will be administered at Screening/Baseline, Mid-treatment (session 8), Post-treatment 
(session 16), and/or 3-month Follow-up (3-months after Post-treatment), except for the primary 
outcome measure (Brief Problem Monitor) and secondary outcome measure (Youth Top 
Problems) which will be administered at Screening/Baseline, weekly throughout therapy, and at 
3-month Follow-up. To minimize avoidable error variance, the parent respondent will be the 
same across timepoints (i.e., families will not switch from a mother to a father reporting on 
outcome measures from one assessment to the next). Families who drop out of treatment before 
session 16 will be offered the opportunity to continue with study assessments on the same 
timeline as if they had remained in treatment through session 16. 
 
In terms of measure administration, paper-and-pencil measures, such as the Brief Problem 
Monitor (BPM; below), will be offered to participants either by mail (with a self-stamped and 
self-addressed envelope for return to UCLA) or by online administration using a proprietary 
secure, HIPAA-compliant internet-based questionnaire data capture tool developed for this study 
at UCLA by Computing Technologies Research Laboratory (CTRL) at the UCLA Semel 
Institute and REDCap. REDCap is a secure web application for building and managing online 
surveys and databases. REDCap can be used to collect virtually any type of data in any 
environment (including compliance with 21 CFR Part 11, FISMA, HIPAA, and GDPR), and it is 
specifically geared to support online and offline data capture for research studies. All measures, 
like the BPM, will also be offered to participants in Spanish (if preferred) either by mail (with a 
self-stamped and self-addressed envelope for return to UCLA) or by online administration using 
a proprietary secure, HIPAA-compliant internet-based questionnaire data capture tool. 
 
Interview measures (e.g., YTP, SACA, and Vineland-3, below) will be administered over the 
phone. 
 
Primary Outcome Measure 
 
Brief Problem Monitor (BPM). The BPM (Achenbach et al., 2011), an abbreviated version of the 
widely used Child Behavior Checklist for Ages 6-18 (CBCL/6-18) will be used as an entry 
criterion for this study, with pretreatment T-scores of = 60 on the Externalizing or Internalizing 
subscale and at least 15 T-score points over 50 between these two subscales (e.g., Internalizing = 
60 + Externalizing = 55) being required for study eligibility. The sum of the parent-report BPM 
Internalizing and Externalizing subscales will also be utilized as the primary outcome measure in 
this study to index treatment-related improvement in symptoms of emotion dysregulation that cut 
across multiple mental health disorders (i.e., anxiety, irritability, depressed mood, anger, 
defiance).  
 
Imperative to effectiveness research, the BPM was selected for both psychometric properties and 
efficiency. Completed in 1 to 2 minutes, the BPM reduces the parent form of the 113-item CBCL 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 20 
to 19-items for rating internalizing, externalizing, and attention problems central to evaluations 
of symptoms of emotional dysregulation. Each item is rated 0 = not true, 1 = somewhat true, or 2 
= very true. Psychometric research shows strong support for the BPM, with high correlations 
between the CBCL and BPM identified for the total score (r = 0.95) as well as the Internalizing 
(0.86), Externalizing (0.93), and Attention (0.97) scales (Piper et al., 2014). BPM subscale scores 
were also higher for children with psychiatric diagnosis (e.g., autism, depression, anxiety, 
attention-deficit hyperactivity disorder) when compared to a sample that had not been diagnosed 
with these disorders. The BPM can be administered remotely via the internet (we have a written 
agreement with the test publisher). The BPM will be administered at baseline, weekly during the 
16 weeks of acute treatment, and again at the 3 month follow up. 
 
Secondary Outcome Measures 
 
Youth Top Problems (YTP) Rating Scale. The YTP approach is a valid and reliable personalized 
assessment method that is sensitive to psychotherapy treatment response in children that allows 
clinicians and researchers to identify problems of the children or adolescents that are especially 
important from the perspective of a caregiver (Weisz et al., 2011, 2012). The YTP caregiver 
interview (YTP) will be administered after the Vineland and SACA at screening.  
 
This interview allows caregivers to state in their own words what current symptoms/problems 
experienced by their child are the most concerning to them. The specific problems are 
transcribed in the parents’ own words. Interviewers then obtain Initial YTP Symptom Severity 
Ratings for each symptom/problem on a scale ranging from 0 (not at all) to 10 (very, very much). 
Up to 12 top symptoms/problems will then be rated weekly throughout the child’s therapy by the 
caregiver.  
 
The YTP will be administered at baseline, weekly during the 16 weeks of acute treatment, and 
again at the 3 month follow up. 
 
Satisfaction with services (SWS). Caregiver satisfaction with treatment will be assessed at Mid- 
and Post-treatment with a short caregiver-report measure used in Hawley and Weisz (2005). 
 
Additional Screening/Baseline Measures 
 
Service Assessment for Children and Adolescents (SACA). The SACA (Horwitz et al., 2001) is 
a psychometrically sound parent interview about the broad use of mental health services. It will 
be administered over the phone by an Independent Evaluator at Baseline and Posttreatment. If 
the youth is taking medication during the study period, the portion of the SACA focused on 
medication type and dosage will be administered to the parent or the treating physician, 
depending on parental awareness of prescription and dose. 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 21 
 
Vineland Adaptive Behavior Scales-3 (Vineland 3). The Vineland 3 (Sparrow et al., 2016) will 
be administered in its parent-report format to assess youth communication skills for study 
eligibility screening (e.g., communication skills). The Vineland-3 has established psychometric 
properties in ASD samples and its Communication Domain score is strongly associated with IQ 
scores in individuals with ASD (e.g., Kanne et al., 2011). It will be administered over the phone 
at baseline. 
 
Therapy Procedures Checklist (TPC). The TPC (Weersing et al., 2002) is a 62-item self-report 
measure used to assess practitioners’ use of treatment techniques that correspond to cognitive, 
behavioral, psychodynamic, or family orientations. Techniques in each orientation are summed 
to create total scores, with high scores reflecting extensive use of techniques consistent with that 
orientation. The TPC has excellent internal consistency and test-retest reliability (Baumann et al., 
2006; Weersing et al., 2002). The TPC also collects information on educational and training 
background (e.g., years of clinical experience). It will be administered at post-treatment. 
 
Background Information Questionnaires. This form collects basic demographic data about the 
family or clinician. It will be administered at baseline. There is a version for families, and a 
version for clinicians. 
 
Implementation Measures 
 
Google Analytics. CBT clinicians’ level of engagement in online training and consultation will 
be evaluated. In the BIACA arm, clinicians’ time spent in video-chat based weekly consultation, 
the initial video-based training, and the use of the online BIACA therapy support materials (e.g., 
reviewing video models of therapy strategies on the meya.ucla.edu website) will be measured 
weekly during the acute phase of treatment. Google Analytics will be used to record the amount 
of time that mental health clinicians are watching the training video and using the support 
materials. 
 
The BIACA Therapist Quiz. Clinicians’ knowledge of CBT will be assessed with the BIACA 
Therapist Quiz consisting of 4 items per module (24 items total) that assess clinicians’ 
knowledge of BIACA concepts and clinical scenarios. This measure will be administered to 
clinicians at posttreatment to assess development of CBT knowledge through the process of 
training and consultation BIACA versus Usual Care/Self-Instruction. The score on the BIACA 
Therapist Quiz ranges from 0 to 24. It will be administered at baseline and post-treatment. 
 
BIACA Fidelity Scales. An important aspect of our previous BIACA work has been the 
development of the BIACA Fidelity Scales (McLeod & Wood, 2018; Wood et al., 2009a) to 
evaluate treatment integrity. These scales measure both the adherence and competence of 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 22 
clinician delivery of key components of BIACA. Adherence refers to the extent to which the 
clinician delivers the treatment as designed, while competence refers to the level of skill and 
responsiveness demonstrated by the clinician when delivering the strategies. Each component 
captures a unique aspect of treatment integrity (Sutherland et al., 2013). Beginning in session 1, 
and then every 4 sessions thereafter, clinicians in both treatment arms will record their treatment 
session with the child and family. These recordings will be rated by trained IEs using the BIACA 
Fidelity Scales. The scoring strategy for the Adherence scale is based upon past treatment 
integrity research designed to yield quantitative data that are non-subjective and are specific with 
regard to how clinicians deliver cognitive-behavioral strategies (e.g., Carroll et al., 2000; Hogue 
et al., 1996; McLeod et al., 2015; Southam-Gerow et al., 2016).  
 
Coders are asked to estimate the extent to which clinicians engage in each strategy during a 
session using a 7-point Likert-type scale with the following anchors: 1 = not at all, 3 = 
somewhat, 5 = considerably, 7 = extensively. The Competence scoring strategy is also based 
upon exemplar coding systems (e.g., Hogueet al., 2008; McLeod et al., 2018). Coders rate items 
on a 7-point Likert-type scale. For each item, coders rate whether a clinician demonstrated: (a) 
Expertise, commitment, motivation; (b) Clarity of language; (c) Appropriate timing 
(skillfulness); and (d) Ability to read and respond to where a child appears to be 
(responsiveness). The BIACA Fidelity Scales will be used not only to assess treatment integrity 
in the BIACA arm, but also to help differentiate and partially characterize the strategies used in 
the Usual Care/Self-Instruction arm.  
 
BIACA Consultation Fidelity scale. Evaluation of consultant’s integrity to the Practice-Based 
Coaching model. All weekly BIACA consultation meetings will be recorded. Consultation 
integrity will be assessed using the BIACA Consultation Fidelity scale. The BIACA expert 
consultant will self-report on this form following each consultation session, and 20% of the 
consultant sessions will be independently observed by a trained RA using the form’s 3-point 
Likert-type scale (Not at all, Somewhat, Extensively) to assess the adherence to the components 
of the consultation model. 
 
CBT clinicians’ perceptions of feasibility and acceptability. Acceptability (i.e., satisfaction with 
various elements of BIACA) and Feasibility (i.e., suitability for use; practicability) will be 
measured using existing measures presented and recorded over video chat at the end of 
treatment. Acceptability and feasibility will be assessed quantitatively using the (1) Evidence-
Based Practice Attitude Scale (Aarons, 2004) and the (2) Usage Rating Profile-Intervention 
(Chafouleas et al., 2011). We will review answers on the measures and use them (3) to guide an 
approximately 20-minute semi-structured interviews with the mental health clinician at the end 
of the acute treatment for clinicians in the BIACA arm. In addition, the following areas will be 
queried in these interviews: the quality and strengths/weaknesses of the online training and 
consultation interface (e.g., length and content of training and session materials and video chat 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 23 
consultations), system efficiency (how much time was put into the weekly session preparation 
and was this viewed as too much or acceptable), and clinical strategies as applied to their clients. 
Recorded interview responses will be transcribed. 
 
Rater Training 
 
All symptom-oriented assessments will be conducted by qualified IEs. Primary IE training for 
symptom measures will be conducted by Dr. Wood during the study startup phase. 
 
Observational coding procedures. For the Implementation measures, Dr. McLeod will train 
research assistants via video conference over 6 weeks during Year 1 using a 3-step process:  
(1) Step 1: Coders will receive didactic instruction, review the scoring manuals, and engage 
in coding exercises to expand understanding of each item.  
(2) Step 2: Coders will independently score sessions from examples pulled from 5 BIACA 
sessions/consultations/training sections selected to maximize variation across each item - 
i.e., illustrate high, medium, and low scores.  
(3) Step 3: Coders will independently score 5 randomly selected BIACA 
sessions/consultations and be required to achieve acceptable item-level reliability (ICC > 
.60) prior to independent coding. These procedures have been used by Dr. McLeod to 
train coders who have achieved adequate reliability in previous studies (e.g., McLeod et 
al., 2015; McLeod et al., 2018; Southam-Gerow et al., 2016; Sutherland et al., 2013). 
 
Maintaining IE blind. Clinicians cannot be blinded to treatment assignments. Accordingly, IEs 
who code the therapy sessions will not attend clinically-oriented meetings and will be trained to 
avoid any discussion of treatment programs with the research team, clinicians and families. The 
inclusion of all participants in the follow-up phase of the study will serve to further uphold the 
blind nature of IEs within the study. 
 
Analytic Design 
 
Data management and analyses will be the primary responsibility of Co-Investigator Dr. Michael 
Seltzer, a professor of Education at UCLA with an international reputation for expertise in 
hierarchical linear modeling in applied research, including the analysis of cluster-randomized 
data. In this proposed study, youth with ASD will be nested within mental health clinicians. 
Hence, Dr. Seltzer’s expertise in cluster-randomized data is essential for appropriate treatment of 
the data. Under Dr.Seltzer’s direction, the graduate student researchers will develop and maintain 
a computerized database for the quantitative study variables, including a double-entry system, 
monthly random auditing, and direct review of the database in weekly research meetings. 
 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 24 
Definition of Primary Outcome Measure: The sum of the BPM Internalizing and Externalizing 
subscales is the primary study outcome measure. 
 
Hypotheses and Analytic Plans for Specific Aims 1-3. 
 
Aim 1. To compare the effectiveness of CBT and usual clinical care for addressing emotion 
dysregulation (e.g., irritability, anxiety) and core autism symptoms in youth with ASD who are 
referred for mental health treatment by their providers in Naval Medical Centers, state-funded 
Regional Centers, or California public schools.  
 
Hypotheses for Specific Aim 1. It is hypothesized that the Consultation-Based Training in 
BIACA condition (referred to as “BIACA”) will outperform the Usual Care Augmented by Self-
Instruction Resources for CBT for Autism condition (referred to as “Usual Care/Self-
Instruction”) as evidenced by differing slopes during treatment on the primary and secondary 
outcome measures, including the sum of the BPM (BPM) Internalizing and Externalizing 
subscales and YTP scores. Additional outcome measures will include the individual BPM 
subscales, SRS-2 scores, and Satisfaction with Services scores. For the BPM subscales, it is 
similarly hypothesized that BIACA will outperform Usual Care/Self-Instruction as evidenced by 
differing slopes during treatment. For the SRS-2 and Satisfaction with Services, it is 
hypothesized that similar group differences will be observed at the Mid-Treatment and Post-
Treatment assessments. For all measures except Satisfaction with Services, it is hypothesized 
that similar group differences will be observed at the 3-month Follow-Up assessment. 
 
Analyses for Aim 1. Numerical and graphical descriptive statistics will be used to summarize the 
data on mental health clinicians and youth, and to assess for the presence of group or site 
differences in screening, demographic or clinical characteristics. Distributional assumptions will 
be checked and appropriate statistical methods for the observed distribution will be applied as 
necessary. Our primary and secondary outcome hypotheses (Aim 1) concern group differences in 
slope between BIACA and Usual Care/Self-Instruction on BPM scores and YTP scores. To 
appropriately handle the cluster-randomized design and maximize the efficiency of parameter 
estimates, we will analyze the outcomes employing linear mixed models (LMMs; Brown & 
Prescott, 2014) or, if there are violations of normality, generalized linear mixed models 
(GLMMs), with timepoints nested within youths, and with group (BIACA, Usual Care/Self-
Instruction) and time as main effects and a group x time interaction term, with a random 
intercept. More complex nesting structures will initially be modeled (with youth nested within 
clinicians, and clinicians nested within sites) and any upper-level effects found to be statistically 
significant will be retained as an additional level of nesting in the final models (cf. Weisz et al. 
2012). Time will be modeled as session number. 
 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 25 
The primary and secondary hypotheses will then be evaluated with the group x time interaction 
term, including estimates of Cohen’s d effect sizes, and we will follow up on any significant 
group x time interaction term with appropriate contrasts. Mixed models automatically handle 
missing data, probing unbiased parameter estimates via maximum likelihood techniques as long 
as observations are missing at random (Gibbons et al., 1993; Laird & Ware, 1982). This will 
allow us to use all available data from all participants in an intent-to-treat (ITT) framework. We 
are also able to control for potential confounding variables in terms of their impact on group 
differences. To protect against Type I error, the principal analyses are designed to answer clearly 
stated major research hypotheses and are based on well-specified dependent variables. All tests 
will be reported using two-tailed family-wise significance level a=.05, using the Holm-
Bonferroni correction (Holm, 1979).  
 
For analyses of the SRS-2 and Satisfaction with Services outcomes, and for all Follow-up 
analyses, LMMs/GLMMs will be used for each post-baseline time point, with group (BIACA, 
Usual Care/Self-Instruction) as a main effect, pre-treatment score as a covariate, and a random 
intercept (the same evaluation and selection of final nesting structures described above will also 
be used for these analyses). 
 
Sensitivity Analysis.  To examine and control for the potential effects of variations in services 
provided in Usual Care/Self-Instruction, the possible presence of some CBT techniques in Usual 
Care/Self-Instruction, the quality of CBT provided in both conditions, and the clinician’s 
background experience with CBT, three sensitivity analyses will be undertaken.  
(1) First, pre-and post-treatment SACA data will be used to construct variables pertaining to 
new episodes of school counseling, social skills groups, speech and language therapy, 
applied behavior analysis, medication dosage increases, and new psychiatric medications 
during the acute treatment phase. The LMM/GLMM models, above, will be rerun with 
these service variables as a block of covariates to test whether concurrent services in 
either treatment condition account for the pattern of findings in the main analyses. 
(2) Similarly, to examine the potential impact of the use of some CBT strategies in the Usual 
Care/Self-Instruction condition (and the quality of the CBT in either condition) on 
treatment outcomes in the main analyses, the LMM/GLMM models, above, will be rerun 
with BIACA Fidelity Scales across all rated sessions combined into an average score and 
included as a covariate. 
(3) Finally, to examine the clinician’s comfort and prior use of CBT in her/his clinical 
practice, the LMM/GLMM models, above, will be rerun with clinicians’ Therapy 
Procedures Checklist (TPC) scores for cognitive and behavioral practices serving as 
covariates. Follow-up exploratory correlational analyses will be conducted within-group 
should either the SACA service variables, the BIACA Fidelity Scales average score, or 
the TPC cognitive and behavioral scale scores affect the statistical significance or reduce 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 26 
the treatment effect size by 25% or more, to identify the source of the covariate’s impact 
on treatment outcome findings. 
 
Aim 2. To characterize the mental health clinicians’ (e.g., psychologists’) level of engagement in 
online training and consultation, knowledge of CBT, perceptions of feasibility and acceptability, 
and treatment integrity.  
 
Hypotheses for Specific Aim 2. It is hypothesized that the BIACA condition will outperform the 
Usual Care/Self-Instruction condition on clinicians’ knowledge of CBT (BIACA Therapist Quiz 
scores) and treatment integrity scores (BIACA Fidelity Scales), that clinicians will engage in at 
least 75% of the training (4 hour video), session preparation (30 min. each on the website), and 
consultation tasks (covering required consultation topics on the BIACA Consultation Integrity 
scale), on average, and that average feasibility and acceptability scores for the CBT arm will be 
within the 95% confidence interval (CI) of mean scores published for these measures (utilizing a 
benchmarking approach; Hogue et al., 2017). For the consultant’s fidelity to the Practice-Based 
Coaching model, we hypothesize that the Consultant will have an average score of at least 75% 
of the maximum possible score of 28 (i.e., M = 21) on the BIACA Consultation Fidelity scale. 
Although there is no specific empirical basis for the value of 75% serving as the benchmark in 
these analyses, it represents a balance between complete engagement or fidelity and a realistic 
“cushion” for unexpected circumstances to occur that periodically disrupt engagement/fidelity. It 
is also hypothesized that qualitative analyses of clinician interview data will reveal themes 
characterizing both positive attitudes towards CBT for youth with ASD as well as complications 
related to the time commitment needed to take on the additional training, consultation, and 
engagement in the study procedures. 
 
Analyses for Aim 2. For clinicians’ knowledge of CBT, the LMM/GLMM models for Aim 1 will 
be refit with BIACA Therapist Quiz scores at post treatment serving as the response variable and 
corresponding BIACA Therapist Quiz scores at pretreatment serving as the covariate. For 
treatment integrity scores, BIACA Fidelity Scales across all rated sessions will be combined into 
an average score and the LMM/GLMM models for Aim 1 will be refit with these composite 
scores serving as the response variable (there will be no pretreatment covariate in this model). 
For clinician engagement, each CBT session will be coded for the length of time in minutes that 
the clinician engaged in session preparation and consultation (Google Analytics is used to 
monitor clinician use of the meya.ucla.edu website and tabulates when and how long training 
resources are used by each clinician; the clinical consultant notes how many consultation topics 
on the BIACA Consultation Integrity Scale were covered in each clinician consultation), and we 
will also code how many minutes of the BIACA training video was watched (assessed with 
Google Analytics). For the clinicians randomized to the BIACA arm, the average length of time 
in which clinicians engaged in preparation/consultation on the meya.ucla.edu website; the length 
of time viewing the training video; and the average proportion of required consultation topics on 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 27 
the BIACA Consultation Integrity scale covered in each clinician consultation will be reported in 
descriptive tables and also compared to the benchmark of 75% of the maximum possible score or 
amount of time recommended (explained in the previous paragraph). For feasibility and 
acceptability scores for the BIACA arm, the 95% CI for the published means for the Evidence-
Based Practice Attitude Scale (Aarons, 2004) and the Usage Rating Profile - Intervention 
(Chafouleas et al., 2011) will be derived to serve as the comparison parameter for the means on 
these two scales. 
 
Qualitative Data Analytic Plan for Aim 2. Each semi-structured clinician interview will be 
digitally recorded and transcribed. Using a constant-comparative approach to data analysis, 
interview transcripts will be coded and reviewed to identify emerging patterns and themes 
related to: (a) feasibility and acceptability of using the CBT strategies with the youth referred to 
the clinician; (b) feasibility and acceptability of the training and consultation procedures in light 
of the clinician’s other work responsibilities and available time; (c) feasibility and acceptability 
of the study procedures (e.g., assessments); (d) administrative or practical supports/barriers to 
implementation of BIACA; (e) any suggestions that the clinician may have pertaining to 
revisions of the CBT strategies, training and consultation, or research procedures. To enhance 
rigor, Dr. McLeod will lead efforts to use qualitative analysis to code the transcripts that emerge 
from these interviews. The initial stage of data analysis (e.g., open coding) will be completed by 
research assistants with supervision via video conference from Dr. McLeod (DeSantis & 
Uganrriza, 2000; Hill et al., 1997; Strauss & Corbin, 1998). Codes will be developed, and 
measures of inter-coder reliability will be calculated and any issues regarding the interpretation 
and application of codes as well as coding disagreements will be discussed by the research 
assistants and investigators and decision rules will be determined. Coding will be refined through 
the process of constant comparison, recoding, and memos. Preliminary findings will be evaluated 
by all investigators for consistency with the definitions related to the five areas. The findings will 
be strengthened by the triangulation of data sources (e.g., transcripts, memos, literature review). 
 
Aim 3. To examine how clinician-level factors (i.e., treatment integrity, feasibility, acceptability) 
and youth-level factors (e.g., age, communication ability) influence youth outcomes in the 
context of CBT delivered in community mental health centers in which training and consultation 
is provided via video conferencing. 
 
Hypotheses for Specific Aim 3. It is hypothesized that in the BIACA arm, improvement on the 
primary, secondary, an additional outcome measures (BPM, YTP, SRS-2, and SWS) over the 
course of treatment will be predicted by higher treatment integrity scores, feasibility and 
acceptability scores, clinicians’ knowledge of CBT, clinicians’ engagement in CBT training, 
older child age, and higher child communication skills. 
 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 28 
Analyses for Aim 3. Analyses for Aim 1 (LMM/GLMM) for the primary, secondary, and 
additional youth outcome measures (BPM, YTP, SRS-2, and SWS) will be refit, selecting only 
clinicians randomized to the BIACA arm, and replacing treatment condition in the model with 
the continuous predictor variables specified in the Analyses for Aim 2, each modeled 
individually instead of as a block of predictors due to power limitations. The same clinician 
variables used to model treatment integrity, feasibility and acceptability, clinicians’ knowledge 
of CBT, and clinicians’ engagement in CBT training and consultation in Analyses for Aim 2 will 
be used as predictors in these models. In addition, youth age and youth scores on the Vineland-3 
Communication scale will be used as predictors in separate models. 
 
Power Analyses and Sample Size Considerations. We will enroll at least N = 50 mental health 
clinicians with 1 to 4 youth clients each (minimum N of clients = 100), with a 1:1 allocation to 
each treatment arm. This sample size was chosen to provide an optimal balance between 
feasibility of recruitment and maximization of power for the primary and secondary aims 
outlined above. Assuming an attrition rate of 10% over the acute treatment period and another 
10% over the 3-month follow-up, which is realistic based on our prior experience (e.g. Wood et 
al., 2009a; 2015; 2020), we expect to have approximately 44 clinician (88 youth) participants at 
the end of acute treatment and 40 (80 youth) at the end of follow-up. All calculations use a 2-
sided significance level of a = .05 and assume a moderate correlation of r = .6 between time 
points within subjects and an ICC = .28 within clinicians, consistent with our previous CBT 
studies (Wood et al., 2006, 2009a,b, 2014, 2015a, 2020). Under these assumptions, using LMM 
we have approximately .86 power to detect a two-group (BIACA vs. Usual Care/Self-
Instruction) difference of d = .50 (a medium effect size) at Post-treatment for LMM models in 
Aims 1-2, even with a complete lack of data from 6 mental health clinicians and the youth nested 
within them (i.e., N = 44). 
 
These power calculations are conservative in that they are based on less favorable assumptions 
than our actual research experience would predict. For example, we have found a maximum ICC 
of .20 for clinician effects in our CBT studies (cf. Wood et al., 2006) so this would be a 
reasonable estimated value; however, the largest clinician effects reported in a large study of 
NIMH RCT data was approximately ICC = .28 (Kim et al., 2006), hence our decision to use this 
value instead of .20. Pre- to post-treatment correlations in our measures of emotion dysregulation 
have averaged r = .71 in our CBT trials for ASD (e.g., Wood et al., 2009a), but we used r = .6 for 
the power analysis to include the lowest hypothetical value for this correlation. Data from 
efficacy studies comparing BIACA to waitlist, usual care, and standard-of-practice CBT have 
consistently yielded effect sizes d > .6 on primary emotion dysregulation outcome measures, and 
in most cases d > 1.0. Although one might suspect the group differences to narrow in an 
effectiveness trial, our power should be adequate to detect the treatment effects of primary 
interest. Further, our power is sufficient to detect group differences at Follow-up, with group 
differences in the order of d = .5 at the 3-month Follow-up resulting in .82 power at alpha = .05 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 29 
assuming a clinician N of 40 (again, conservatively assuming the worst-case scenario, a 
complete lack of data for 10 clinicians and 20 associated youth). 
 
For the predictor analyses in Aim 3, LMMs/GLMMs will be refit with just BIACA arm mental 
health clinicians, and .90 power will be achieved for a predictor of Post-treatment scores with an 
effect size of f = .25 (a medium effect). Power calculations for the LMMs were performed in 
GLIMMPSE multilevel power software, a project funded by the National Institute of Health 
(Kreidler et al., 2013). 
 
Missing Data and Attrition. Our primary analytic tool is LMM, which provides unbiased 
parameter estimates when data are missing at random. LMM estimates are based on maximum 
likelihood techniques and do not require imputation. However, because the intermediate time 
points for participants who do not complete the full protocol provide information about their 
trajectory, if warranted by unexpectedly high dropout rates, we will consider imputation and 
propensity score approaches to project post treatment and follow-up scores or to handle bias 
problems. Imputation with fully conditional specification using all variables in the primary 
model as the predictors of post-treatment scores was used as a sensitivity analysis in our recent 
large RCT of BIACA (Wood et al., 2020), and this, or a similar approach, to imputation can be 
used in the proposed trial as needed. Every effort will be made to prevent dropouts/missing data, 
and to complete relevant assessments for youth who drop out. 
 
We understand that participants may voluntarily withdraw for various reasons (e.g., relocation or 
additional time commitments). Though we have experienced minimal attrition in our previous 
work (i.e., Wood et al., 2020), we have incorporated design features into the proposed study to 
minimize attrition. We will collaboratively schedule consultation sessions with clinicians, ensure 
that meeting length is not excessive, and provide financial incentives for completion of 
assessments to the clinicians and families in both the BIACA condition and Usual Care/Self-
Instruction condition. The same training in the BIACA arm (with associated compensation for 
treating one youth with BIACA and completing assessments) will be offered to Usual Care/Self-
Instruction clinicians once they complete the study protocol in Usual Care/Self-Instruction. 
 
Even if attrition occurs in the middle of the treatment, all available data from all participants will 
be included in the analyses using an intent to treat framework (Salim et al., 2008). If attrition is 
above 10%, we will conduct chi-square tests and mean comparisons to determine whether this 
attrition is related to any demographic or baseline clinical variables, and if so, we will include 
these variables as covariates. 
 
A recent meta-analysis found that the number of sessions completed in head-to-head 
comparisons of evidence-based treatments and usual care was greater for evidence-based 
treatments in 11 studies and the number of sessions was greater in usual care in 8 studies (Weisz 

CYAN Protocol | Version Date 01/30/2023  
 
 
 
 
Page 30 
et al., 2013), suggesting premature dropout would not be expected to differentially impact usual 
care in studies of the sort we have proposed. However, should either condition exhibit a greater 
rate of dropout in this study, the number of sessions completed will be incorporated in the 
statistical models assessing treatment effectiveness.