Research on biomarkers for anxiety in children with autism
Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed With Autism Spectrum Disorder and Co-occurring Anxiety
This study is testing if certain biological markers can help predict how well children with autism respond to a therapy program for anxiety called Being Brave.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 3 Years to 6 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Brookline, Massachusetts) |
| Trial ID | NCT06221176 on ClinicalTrials.gov |
What this trial studies
This study investigates four biomarkers in children with autism spectrum disorder to evaluate their stability and predictive ability regarding treatment response to a cognitive behavioral therapy program called Being Brave. Using a within-subjects design, the study aims to assess how these biomarkers can quantify changes in anxiety levels over a 3-4 week period. The research focuses on determining which baseline biomarker scores can predict treatment outcomes and which biomarkers are sensitive to changes following therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 6 years with a diagnosis of autism spectrum disorder and anxiety disorder.
Not a fit: Patients with significant sensory or motor impairments, seizures, or known genetic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more personalized and effective treatment strategies for anxiety in children with autism.
How similar studies have performed: Other studies have explored biomarkers in autism and anxiety, but this specific approach focusing on treatment response prediction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 3;0 and 6;11 years old * A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria * A diagnosis of anxiety disorder using DSM-5 diagnostic criteria * Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2) * Cognitive ability (either verbal or non-verbal IQ) \> 80 using the DAS-2 * A parent/guardian who is willing/able to participate and respond to interviews/surveys in English and willing/able to participate in Being Brave parent training in English and support homework activities. Exclusion Criteria: * Presence of seizures * Premature birth (\<36 weeks) or low birth weight (\<2500 gms) * Known genetic or medical disorders (e.g., Fragile X), or injuries (e.g., stroke) with implications for the nervous system or that require regular psychoactive medication that alter EEG/RSA/EDR signal (e.g., anti-convulsants) * Significant sensory or motor impairment (e.g., blindness) * Major physical abnormalities * Exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation) * Previous CBT for anxiety * Presence of conduct or oppositional defiant disorder or ADHD so severe as to interfere with the child's ability to take part in treatment * Presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality) * Psychotic symptoms in the child or parents * Parent/caregiver who is not fluent in English or English is spoken in the home less than half of the time.
Where this trial is running
Brookline, Massachusetts
- Boston Children's Hospital, Two Brookline Place — Brookline, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Susan C Faja, PhD
- Email: susan.faja@childrens.harvard.edu
- Phone: 16179194486
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.