Clinical trial NCT05031364: CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
Official title: Effectiveness of Evidence-Based Mental Health Practices for Youth With Autism Supported by Online Consultation to Practitioners in Community and Navy Clinics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
name: United States Naval Medical Center, San Diego
name: Westside Regional Center
name: California Autism Professional Training and Information Network
First posted: 2021-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Clinician's inclusion criteria: 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 therapy, social work) and will serve youth with ASD referred by the Regional Centers, Tricare/NMCSD, or the California public schools. Practitioners will agree to invite one or more potentially eligible families of youth with ASD so that, in total, at least 2 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.). Up to four families per practitioner will be allowed so long as the minimum study enrollment of at least 50 practitioners and 100 client families randomized is met.

Youth inclusion criteria: 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. Additional eligibility criteria are as follows:

1. 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.
2. 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).
3. 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).
4. 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 Criteria:

1. 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.

Primary outcomes:
measure: Change in Brief Problem Monitor (BPM)
timeFrame: Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)
Secondary outcomes:
measure: Change in Youth Top Problems (YTP) Rating Scale
timeFrame: Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)
measure: Change in Social Responsiveness Scale II (SRS-II)
timeFrame: Baseline (week 0), Session 8 (approximately week 8), Immediate Post-Treatment [approx. week 16], and Follow-up (approx. week 29)
measure: Consumer Satisfaction Parent Questionnaire
timeFrame: Immediate Post-Treatment [approximately week 16]
Other outcomes:
measure: Therapy Procedures Checklist (TPC)
timeFrame: Immediate Post-Treatment [approximately week 16]
measure: The Modular EBPs for Youth with Autism Fidelity Scale (MEYA-FS; McLeod et al., 2022)
timeFrame: Sessions 1 [approximately week 1], 5 [approx. week 5], 9 [approx. week 9], and 13 [approx. week 13]
measure: Change in BIACA Therapist Quiz
timeFrame: Baseline [week 0] and Immediate Post-Treatment [approximately week 16]
measure: Mixed-methods feedback on training and consultation in BIACA
timeFrame: Immediate Post-Treatment [approximately week 16]
Locations:
city: Culver City
country: United States
facility: Westside Regional Center
state: California
city: Sacramento
country: United States
facility: California Autism Professional Training and Information Network (CAPTAIN)
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: University of California
name: Wood
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wood JJ, Kendall PC, Wood KS, Kerns CM, Seltzer M, Small BJ, Lewin AB, Storch EA. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):474-483. doi: 10.1001/jamapsychiatry.2019.4160.
citation: Wood JJ, Ehrenreich-May J, Alessandri M, Fujii C, Renno P, Laugeson E, Piacentini JC, De Nadai AS, Arnold E, Lewin AB, Murphy TK, Storch EA. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial. Behav Ther. 2015 Jan;46(1):7-19. doi: 10.1016/j.beth.2014.01.002. Epub 2014 Jan 22.
citation: Wood JJ, McLeod BD, Klebanoff S, Brookman-Frazee L. Toward the implementation of evidence-based interventions for youth with autism spectrum disorders in schools and community agencies. Behav Ther. 2015 Jan;46(1):83-95. doi: 10.1016/j.beth.2014.07.003. Epub 2014 Jul 30.
citation: Lecavalier L, Wood JJ, Halladay AK, Jones NE, Aman MG, Cook EH, Handen BL, King BH, Pearson DA, Hallett V, Sullivan KA, Grondhuis S, Bishop SL, Horrigan JP, Dawson G, Scahill L. Measuring anxiety as a treatment endpoint in youth with autism spectrum disorder. J Autism Dev Disord. 2014 May;44(5):1128-43. doi: 10.1007/s10803-013-1974-9.