Autism Spectrum DisorderNCT06066983
DINO RCT - Treating Anxiety in Children With Autism
A study testing DINOSAUR and Psychoeducation in people with Autism Spectrum Disorder and Anxiety Disorders, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Anxiety Disorders
- What is being tested?
- DINOSAUR and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to 31 Dec 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 4 years 0 months to 6 years 11 months
- DSM-5 ASD diagnosis based on clinical impressions and results of the Autism Diagnostic Observation Schedule-2 (ADOS-2)
- CBCL Anxiety Problems T-score > 65
- SB-5 ABIQ > 60
- Receptive and expressive language age equivalent > 36 months based on Test of Early Language Development, Fourth Edition (TELD-4)
- Parent (or other caregiver) available and willing to attend 14-week intervention
- Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberous sclerosis, neurofibromatosis) or severe sensory-motor (e.g., severe vision impairment) conditions
- Able to walk independently (a requirement for ADOS-2)
Who cannot join
- Primary language other than English
- Child is in foster care
- Child displays severe behavior challenges that prevent participation in treatment groups (i.e., severe tantrums, aggression, or self-injury)
- Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21211
Belina Onomake, 667-205-4036, OnomakeB@kennedykrieger.org
Amy Keefer, PhD
About this study
Official title: Treating Anxiety in Young Children With Autism
Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.
Read the detailed description
The purpose of this study is to examine the feasibility and preliminary efficacy of a new treatment that targets both anxiety and IU, i.e., DINOSAUR, in young autistic children with varying cognitive and language levels. To accomplish this goal, we will investigate if DINOSAUR is a feasible intervention for families of young autistic children. We will also investigate if DINOSAUR is superior to an active control condition in reducing anxiety and IU. A third, exploratory goal is to understand how children's language and cognitive level affect their response to anxiety treatment. Seventy children, 4-6 years of age with autism and clinically significant anxiety, and their parents will be randomly assigned to receive either DINOSAUR or the active control (35 in each group) over 14 weeks via telehealth. Within each condition, children will be stratified based on cognitive level. Anxiety and IU will be assessed following treatment and at 4-month follow-up.
- Conditions
- Autism Spectrum Disorder, Anxiety Disorders
- Being tested
- DINOSAUR, Psychoeducation
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DINOSAURBehavioural
This intervention aims to treat intolerance of uncertainty and anxiety in young autistic children.
PsychoeducationOther
This intervention provides psychoeducation regarding anxiety and autism.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Parent-child dyads will receive DINOSAUR, a group-based cognitive-behavioral therapy (CBT) intervention, adapted for young children and delivered via telehealth. This 14 week intervention teaches parents and children strategies to reduce anxiety and intolerance of uncertainty, an underlying construct of anxiety. Receives: Behavioral: DINOSAUR |
| Active Control | Active comparator | Parents in the active control condition will participate in three psychoeducational groups focused on presenting information regarding anxiety prevalence, differentiating anxiety from autism, and anxiety triggers. These groups will be delivered via telehealth across a 14-week period. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
The Anxiety Disorders Interview Schedule (ADIS) is a semi-structured parent interview assessing the severity of anxiety disorders and its presentation in individuals with autism.
Measured: Before and after 14-week treatment (baseline to post-treatment)
Secondary outcomes (3)
Change in anxiety severity on Child Behavior Checklist
An established 99-item parent and teacher report of broad psychopathology; T scores range from 20 to 100; Syndrome scales: T-scores over 65 indicate clinically significant symptoms.
Measured: Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
Change in child's intolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale
Parent and teacher report scale measuring response to uncertainty and low environmental structure; scores range from 1 to 5; higher scores indicate higher intolerance of uncertainty.
Measured: Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
Change on parental accommodating behaviors on Family Accommodation Scale following 14-week active control and 14-week intervention.
Assesses parental accommodating behaviors; scores range from 0 to 36; higher scores indicate higher parental accommodation.
Measured: Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start2 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Keefer, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066983
- Sponsor's protocol ID
- IRB00343724
- Other IDs
- CDMRP - AR220066
- Status last verified
- Nov 2026
- First submitted
- 28 Sep 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keefer A, Vasa RA. DINOSAUR: an integrated cognitive-behavioral treatment for anxiety in young children with ASD. J Neurodev Disord. 2021 Oct 11;13(1):46. doi: 10.1186/s11689-021-09396-9.
PubMed 34635048Vasa RA, Kerns CM, Singh V, McDonald R, Jang YS, Keefer A. Anxiety in autistic preschool children: Phenomenology and a network analysis of correlates. Autism Res. 2023 Aug;16(8):1561-1572. doi: 10.1002/aur.2968. Epub 2023 Jun 23.
PubMed 37350221
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Anxiety in Young Children With Autism
- ClinicalTrials.gov ID
- NCT06066983
- Acronym / sponsor ID
- IRB00343724
- Conditions
- Autism Spectrum Disorder, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Oct 2023 (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.
Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.
Detailed description
The purpose of this study is to examine the feasibility and preliminary efficacy of a new treatment that targets both anxiety and IU, i.e., DINOSAUR, in young autistic children with varying cognitive and language levels. To accomplish this goal, we will investigate if DINOSAUR is a feasible intervention for families of young autistic children. We will also investigate if DINOSAUR is superior to an active control condition in reducing anxiety and IU. A third, exploratory goal is to understand how children's language and cognitive level affect their response to anxiety treatment. Seventy children, 4-6 years of age with autism and clinically significant anxiety, and their parents will be randomly assigned to receive either DINOSAUR or the active control (35 in each group) over 14 weeks via telehealth. Within each condition, children will be stratified based on cognitive level. Anxiety and IU will be assessed following treatment and at 4-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: DINOSAURParent-child dyads will receive DINOSAUR, a group-based cognitive-behavioral therapy (CBT) intervention, adapted for young children and delivered via telehealth. This 14 week intervention teaches parents and children strategies to reduce anxiety and intolerance of uncertainty, an underlying construct of anxiety. |
| Active Control | Active comparator | Other: PsychoeducationParents in the active control condition will participate in three psychoeducational groups focused on presenting information regarding anxiety prevalence, differentiating anxiety from autism, and anxiety triggers. These groups will be delivered via telehealth across a 14-week period. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 4 years 0 months to 6 years 11 months
- DSM-5 ASD diagnosis based on clinical impressions and results of the Autism Diagnostic Observation Schedule-2 (ADOS-2)
- CBCL Anxiety Problems T-score > 65
- SB-5 ABIQ > 60
- Receptive and expressive language age equivalent > 36 months based on Test of Early Language Development, Fourth Edition (TELD-4)
Key exclusion criteria (4 listed)
- Primary language other than English
- Child is in foster care
- Child displays severe behavior challenges that prevent participation in treatment groups (i.e., severe tantrums, aggression, or self-injury)
- Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)
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 |
|---|---|---|
| DINOSAURThis intervention aims to treat intolerance of uncertainty and anxiety in young autistic children. | Behavioural | Treatment |
| PsychoeducationThis intervention provides psychoeducation regarding anxiety and autism. | Other | Active Control |
Primary outcome
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
Time frame: Before and after 14-week treatment (baseline to post-treatment)
The Anxiety Disorders Interview Schedule (ADIS) is a semi-structured parent interview assessing the severity of anxiety disorders and its presentation in individuals with autism.
3 secondary outcomes
Change in anxiety severity on Child Behavior Checklist
Time frame: Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
Change in child's intolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale
Time frame: Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
Change on parental accommodating behaviors on Family Accommodation Scale following 14-week active control and 14-week intervention.
Time frame: Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
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 4 Nov 2026.
- Results publication: PubMed 34635048Keefer A, Vasa RA. DINOSAUR: an integrated cognitive-behavioral treatment for anxiety in young children with ASD. J Neurodev Disord. 2021 Oct 11;13(1):46. doi: 10.1186/s11689-021-09396-9.
- Results publication: PubMed 37350221Vasa RA, Kerns CM, Singh V, McDonald R, Jang YS, Keefer A. Anxiety in autistic preschool children: Phenomenology and a network analysis of correlates. Autism Res. 2023 Aug;16(8):1561-1572. doi: 10.1002/aur.2968. Epub 2023 Jun 23.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DINOSAUR and Psychoeducation in people with Autism Spectrum Disorder and Anxiety Disorders, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Belina Onomake (667-205-4036, OnomakeB@kennedykrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA) (time frame: Before and after 14-week treatment (baseline to post-treatment)). 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 NCT06066983, which also lists 2 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 4 Nov 2026.