RecruitingNot ApplicableNCT05031364

CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings

Effectiveness of Evidence-Based Mental Health Practices for Youth With Autism Supported by Online Consultation to Practitioners in Community and Navy Clinics

Sponsor

University of California, Los Angeles

Enrollment

100 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

Autism

Summary

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.

Eligibility

Min Age: 6 YearsMax Age: 14 Years

Inclusion Criteria4

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.
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).
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).
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 %ile).

Exclusion Criteria1

\. For participants presenting with severe comorbid symptomology (e.g., psychotic symptoms), the comorbid conditions cannot be sufficiently severe to warrant immediate treatment or require ongoing medication titration.

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Interventions

BEHAVIORALBehavioral Interventions for Anxiety in Children with Autism (BIACA)

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.

BEHAVIORALTreatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA)

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.