Telehealth intervention for anxiety in young children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kennedy Krieger Institute
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Belina Onomake
• Email: OnomakeB@kennedykrieger.org
• Phone: 667-205-4036

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.