AutismCYANNCT05031364
CBT for Youth With Autism and Emotional/Behavioral Needs in Community Care Settings
A study testing Behavioral Interventions for Anxiety in Children with Autism (BIACA) and Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA) in people with Autism, run by University of California, Los Angeles at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Autism
- What is being tested?
- Behavioral Interventions for Anxiety in Children with Autism (BIACA) and Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2021to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Westside Regional Center
Culver City, California, 90024
California Autism Professional Training and Information Network (CAPTAIN)
Sacramento, California, 95817
Naval Medical Center San Diego
San Diego, California, 92115
About this study
Official title: Effectiveness of Evidence-Based Mental Health Practices for Youth With Autism Supported by Online Consultation to Practitioners in Community and Navy Clinics
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.
- Conditions
- Autism
- Being tested
- Behavioral Interventions for Anxiety in Children with Autism (BIACA), Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA)
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Interventions for Anxiety in Children with Autism (BIACA)Behavioural
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.
Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Consultation-Based Training on BIACA | Experimental | 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. Receives: Behavioral: Behavioral Interventions for Anxiety in Children with Autism (BIACA) |
| Usual Care Augmented by Self-Instruction Resources for CBT for Autism | Active comparator | 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. Receives: Behavioral: Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: Immediate Post-Treatment [approximately week 16]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Jul 2021
- Primary completion1 Jun 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University, United States Naval Medical Center, San Diego, Westside Regional Center, California Autism Professional Training and Information Network
- Responsible party
- Principal investigator, Jeffrey J. Wood, University of California, Los Angeles
- Investigators
- Wood, Principal investigator, University of California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031364
- Sponsor's protocol ID
- AR200108
- Acronym
- CYAN
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To comply with the Policy, we propose to make de-identified data, codebooks, and documentation available under the auspices of the National Database for Autism Research (NDAR) (for data) and the PI's UCLA website (for codebooks, documentation, etc.). The study protocol is posted on clinicaltrials.gov.
Publications
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.
PubMed 31755906Wood 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.
PubMed 25526831Wood 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.
PubMed 25526837Lecavalier 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.
PubMed 24158679
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Evidence-Based Mental Health Practices for Youth With Autism Supported by Online Consultation to Practitioners in Community and Navy Clinics
- ClinicalTrials.gov ID
- NCT05031364
- Acronym / sponsor ID
- CYAN / AR200108
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University, United States Naval Medical Center, San Diego, Westside Regional Center, California Autism Professional Training and Information Network
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consultation-Based Training on BIACA | Experimental | Behavioral: Behavioral Interventions for Anxiety in Children with Autism (BIACA)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. |
| Usual Care Augmented by Self-Instruction Resources for CBT for Autism | Active comparator | Behavioral: Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA)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. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Behavioural | Consultation-Based Training on BIACA |
| 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 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. | Behavioural | Usual Care Augmented by Self-Instruction Resources for CBT for Autism |
Primary outcome
Change in Brief Problem Monitor (BPM)
Time frame: Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)
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.
3 secondary outcomes
Change in Youth Top Problems (YTP) Rating Scale
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)
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
Time frame: Immediate Post-Treatment [approximately week 16]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 31755906Wood 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.
- Background: PubMed 25526831Wood 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.
- Background: PubMed 25526837Wood 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.
- Background: PubMed 24158679Lecavalier 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.
- Online repository of CBT practices used in the training/consultation protocol.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. To comply with the Policy, we propose to make de-identified data, codebooks, and documentation available under the auspices of the National Database for Autism Research (NDAR) (for data) and the PI's UCLA website (for codebooks, documentation, etc.). The study protocol is posted on clinicaltrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wood principal investigator
University of California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Interventions for Anxiety in Children with Autism (BIACA) and Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA) in people with Autism, run by University of California, Los Angeles at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief Problem Monitor (BPM) (time frame: Baseline (week 0), Sessions 1 to 16 (weekly, approximately weeks 1 to 16), and Follow-up (approx. week 29)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031364, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.