This study is a 4-year randomized, controlled trial comparing cognitive behavioral therapy (CBT) to usual clinical care for children (aged 6-14 years) with autism and emotional dysregulation (e.g., irritability, anxiety). We will randomly assign 50 mental health clinicians, each treating 2 youth (N = 100 youth total), to CBT program for emotional dysregulation and core autism symptoms with weekly live consultation with an expert or to usual clinical care augmented by self-instruction in CBT, in a 1:1 allocation. The CBT manual is well-supported in our efficacy research, has been replicated in other centers, 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
In the BIACA CBT program (e.g., Wood et al., 2020), clinicians work with families for 16 weekly sessions that include both the child and parent(s). In BIACA, anxiety, rigidity and inflexible routines, and irritability are all addressed using in vivo exposure therapy strategies during sessions as well as parent (and teacher) training to promote regulation across settings. ASD-related clinical needs that can impact mental health and emotion regulation such as friendship skills and social entry skills (e.g., joining games at school) are addressed with modeling, self-management, and parent- (or teacher-) implemented social coaching in daily settings. For youth with limited communication, therapy is adapted through the use of play-based representations of challenging situations and an emphasis on more action-oriented exposure therapy.
Participating clinicians are expected to have varied training in numerous psychological therapy procedures (e.g., insight-oriented procedures, cognitive interventions, family therapy, etc.), any or all of which they may choose to implement with a participating child. These practices will be characterized through the Therapy Procedures Checklist (Weersing et al., 2002). Additionally, participating clinicians will be provided with information about self-instruction resources on CBT for children with autism, namely, the Modular Evidence-Based Practices for Youth with Autism (MEYA) website developed by our research group. MEYA is freely accessible to clinicians worldwide at meya.ucla.edu. MEYA incorporates treatment elements of both BIACA (Wood et al., 2020) and SEBASTIEN (Wood et al., 2021), which was designed to address additional autism-related clinical needs (e.g., reciprocal conversation). Clinicians in this arm will provide up to 16 therapy sessions.
Westside Regional Center
Culver City, California, United States
RECRUITINGCalifornia Autism Professional Training and Information Network (CAPTAIN)
Sacramento, California, United States
RECRUITINGNaval Medical Center San Diego
San Diego, California, United States
RECRUITINGChange in Brief Problem Monitor (BPM)
The BPM (Achenbach et al., 2011) is an abbreviated version of the widely used Child Behavior Checklist (CBCL; Achenbach \& Rescorla, 2001). The sum of the parent-report BPM Internalizing and Externalizing subscales will be utilized as the primary outcome measure in this study to index improvement across core aspects of children's mental health (i.e., anxiety, irritability, depressed mood, defiance). The BPM is comprised of 19 items. Each item is rated 0 = not true, 1 = somewhat true, or 2 = very true. Higher scores reflect more problems. Research suggests the BPM has good reliability and validity and is sensitive to change in effectiveness studies of youth psychotherapy (Piper et al., 2014; Weisz et al., 2012). The BPM can be administered remotely via the internet.
Time frame: Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)
Change in 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-P) will be administered after 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 problem on a scale ranging from 0 (not at all) to 10 (very, very much). The top 12 problems will then be rated weekly throughout the child's therapy by the caregiver. Higher scores reflect more significant problems.
Time frame: Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)
Change in Social Responsiveness Scale II (SRS-II)
The SRS-II (Constantino \& Gruber, 2012) is a 65-item parent-rated scale measuring the severity of ASD symptoms. The SRS-II has high internal consistency, convergence with other measures of ASD severity, and discriminates between youth with and without ASD (Schanding et al., 2011). It has shown treatment sensitivity in all extant clinical trials of BIACA including the replications by Storch and colleagues; versus treatment-as-usual; and versus standard-of-practice CBT (e.g., Storch et al., 2013, 2015; Wood et al., 2009b, 2015a, 2020).
Time frame: Baseline (week 0), Session 8 (approximately week 8), Immediate Post-Treatment [approx. week 16], and Follow-up (approx. week 29)
Consumer Satisfaction Parent Questionnaire
Parent satisfaction with treatment will be assessed with an 11-item parent-report measure.
Time frame: Immediate Post-Treatment [approximately week 16]
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.