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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Behavioral 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 ski
• Поведенческое Treatment-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 wi

Первичные конечные точки

• Change in Brief Problem Monitor (BPM) [Срок оценки: Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)]

Вторичные конечные точки (3)

• Change in Youth Top Problems (YTP) Rating Scale [Срок оценки: 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) [Срок оценки: Baseline (week 0), Session 8 (approximately week 8), Immediate Post-Treatment [approx. week 16], and Follow-up (approx. week 29)]
• Consumer Satisfaction Parent Questionnaire [Срок оценки: Immediate Post-Treatment [approximately week 16]]

Критерии участия

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:

• 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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Westside Regional Center — Culver City
• California Autism Professional Training and Information Network (CAPTAIN) — Sacramento
• Naval Medical Center San Diego — San Diego

Публикации

• 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. PMID 31755906
• 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. PMID 25526831
• 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. PMID 25526837
• 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. PMID 24158679

Идентификаторы

NCT: NCT05031364 · AR200108

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗