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

Primary Purpose

Autism

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral Interventions for Anxiety in Children with Autism (BIACA)

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

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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).

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.

Sites / Locations

Westside Regional CenterRecruiting
California Autism Professional Training and Information Network (CAPTAIN)Recruiting
Naval Medical Center San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Consultation-Based Training on BIACA

Usual Care Augmented by Self-Instruction Resources for CBT for Autism

Arm Description

Community mental health clinicians will be given online one-on-one training and consultation in the BIACA (Behavioral Interventions for Anxiety in Children with Autism; e.g., Wood et al., 2020) CBT program. Clinicians will be provided with weekly 30-minute video-conference-based consultation sessions with an expert in BIACA. These consultation sessions are manual-driven and utilize a Practice-Based Coaching format, in which a trained consultant meets weekly with clinicians to provide practice-based feedback (cf. McLeod et al., 2018). Consultation meetings include agenda setting, case material review, planning for the next treatment session, and a meeting summary. Relevant online training materials (e.g., demonstration videos of CBT sessions; corresponding written session materials) developed in the context of a NIMH R34 grant available on meya.ucla.edu (1R34MH110591) will also be provided to clinicians for each upcoming therapy session.

Community mental health clinicians in this arm will provide any therapy, counseling, and/or behavioral treatment procedures they deem appropriate for each participating child. Clinicians randomized to this arm will be given immediate access to CBT-for-autism self-instruction materials that are already freely available to any clinician at meya.ucla.edu (see Consultation-Based Training on BIACA arm, above), 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.

Outcomes

Primary Outcome Measures

Change 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.

Secondary Outcome Measures

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 6 problems will then be rated weekly throughout the child's therapy by the caregiver. Higher scores reflect more significant problems.

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).

Consumer Satisfaction Parent Questionnaire

Parent satisfaction with treatment will be assessed with an 11-item parent-report measure.

Full Information

NCT ID

NCT05031364

First Posted

July 28, 2021

Last Updated

October 12, 2022

Sponsor

University of California, Los Angeles

Collaborators

Virginia Commonwealth University, United States Naval Medical Center, San Diego, Westside Regional Center, California Autism Professional Training and Information Network

1. Study Identification

Unique Protocol Identification Number

NCT05031364

Brief Title

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

Acronym

CYAN

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

March 1, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

Virginia Commonwealth University, United States Naval Medical Center, San Diego, Westside Regional Center, California Autism Professional Training and Information Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Treatment condition and timepoint will be masked for the outcomes assessors (independent evaluators [IEs]), who will administer the interview-based measures.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Consultation-Based Training on BIACA

Arm Type

Experimental

Arm Description

Arm Title

Usual Care Augmented by Self-Instruction Resources for CBT for Autism

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Interventions for Anxiety in Children with Autism (BIACA)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Brief Problem Monitor (BPM)

Description

Time Frame

Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)

Secondary Outcome Measure Information:

Title

Change in Youth Top Problems (YTP) Rating Scale

Description

Time Frame

Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)

Title

Change in Social Responsiveness Scale II (SRS-II)

Description

Time Frame

Baseline (week 0), Session 8 (approximately week 8), Immediate Post-Treatment [approx. week 16], and Follow-up (approx. week 29)

Title

Consumer Satisfaction Parent Questionnaire

Description

Parent satisfaction with treatment will be assessed with an 11-item parent-report measure.

Time Frame

Immediate Post-Treatment [approximately week 16]

Other Pre-specified Outcome Measures:

Title

Therapy Procedures Checklist (TPC)

Description

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 higher scores reflecting more 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). Item scores range from 1 (rarely) to 5 (most of the time).

Time Frame

Immediate Post-Treatment [approximately week 16]

Title

The Modular EBPs for Youth with Autism Fidelity Scale (MEYA-FS; McLeod et al., 2022)

Description

The MEYA-FS is a 32-item measure designed to assess clinician adherence and competence for practices found in EBPs for autistic youth. 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. 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. Higher scores reflect greater adherence and competence.

Time Frame

Sessions 1 [approximately week 1], 5 [approx. week 5], 9 [approx. week 9], and 13 [approx. week 13]

Title

Change in BIACA Therapist Quiz

Description

The BIACA Therapist Quiz assesses clinicians' knowledge of BIACA concepts and clinical scenarios. This measure will be administered to clinicians at pretreatment and posttreatment to assess development of CBT knowledge through the process of training and consultation in BIACA.

Time Frame

Baseline [week 0] and Immediate Post-Treatment [approximately week 16]

Title

Mixed-methods feedback on training and consultation in BIACA

Description

Acceptability and feasibility of training/consultation in BIACA will be assessed quantitatively using the Evidence-Based Practice Attitude Scale (Aarons, 2004) and the Usage Rating Profile-Intervention (Chafouleas et al., 2011). We will review answers on the measures and use them to guide 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 videochat 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.

Time Frame

Immediate Post-Treatment [approximately week 16]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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: 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wood

Phone

310-882-0537

meya@gseis.ucla.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wood

Organizational Affiliation

University of California

Official's Role

Principal Investigator

Facility Information:

Facility Name

Westside Regional Center

City

Culver City

State/Province

California

ZIP/Postal Code

90024

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wood

Phone

310-882-0537

meya@gseis.ucla.edu

Facility Name

California Autism Professional Training and Information Network (CAPTAIN)

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

J Wood

Phone

310-882-0537

meya@gseis.ucla.edu

Facility Name

Naval Medical Center San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wood

Phone

310-882-0537

meya@gseis.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

To comply with the Policy, we propose to make de-identified data, codebooks, documentation, and research protocols available under the auspices of the National Database for Autism Research (NDAR) (for data) and the PI's UCLA website (for codebooks, documentation, etc.).

IPD Sharing Time Frame

Datasets associated with manuscripts that are published during or following the grant period will be available once each manuscript is made available by the publisher. The final data set will be made available from Dr. Wood within 3 years after the end of all data collection activities. All datasets will be stored and made available for a minimum of 10 years or longer, depending on the extant NDAR policies.

IPD Sharing Access Criteria

NDAR sets a universal policy for accessing its datasets. Other information (e.g., study protocol) will be freely available on the PI's website.

Citations:

PubMed Identifier

31755906

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.

Results Reference

background

PubMed Identifier

25526831

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.

Results Reference

background

PubMed Identifier

25526837

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.

Results Reference

background

PubMed Identifier

24158679

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.

Results Reference

background

Links:

URL

http://meya.ucla.edu

Description

Online repository of CBT practices used in the training/consultation protocol.

Learn more about this trial

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

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