Telehealth intervention for anxiety in young children with autism
Treating Anxiety in Young Children With Autism
This study is testing a new online therapy called DINOSAUR to see if it can help reduce anxiety in young children with autism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06066983 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and preliminary efficacy of a novel telehealth cognitive-behavioral therapy intervention called DINOSAUR, designed to reduce anxiety and intolerance of uncertainty in young children with autism. The trial will involve 70 children aged 4 to 6 years who will be randomly assigned to receive either the DINOSAUR intervention or an active control over a 14-week period. The study aims to assess the effectiveness of the intervention in reducing anxiety symptoms and to explore how children's cognitive and language levels influence treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 6 years with a diagnosis of autism spectrum disorder and clinically significant anxiety.
Not a fit: Patients who may not benefit from this study include those with severe behavioral challenges or identifiable neurological or genetic conditions.
Why it matters
Potential benefit: If successful, this intervention could provide an effective treatment option for reducing anxiety in young autistic children, improving their overall well-being.
How similar studies have performed: Other studies have shown success with cognitive-behavioral therapy approaches for anxiety in older autistic children, but this specific intervention for younger children is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
Where this trial is running
Baltimore, Maryland
- Kennedy Krieger Institute — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Belina Onomake
- Email: OnomakeB@kennedykrieger.org
- Phone: 667-205-4036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.