Behavioral therapy for managing irritability in adolescents with autism
Behavior Therapy for Irritability and Aggression in Adolescents With Autism
This study is testing a new therapy designed to help teenagers with autism manage their irritability and aggression better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 12 Years to 19 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04654260 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel intervention called Behavioral Therapy for Irritability and Aggression (BTIA) aimed at adolescents aged 12 to 18 with autism spectrum disorder. The study involves a randomized controlled design comparing BTIA to a supportive therapy control, with 126 participants receiving 15 weekly sessions focused on emotion regulation and coping skills. The effectiveness of BTIA will be assessed by a blinded evaluator measuring reductions in disruptive behaviors and improvements in adaptive functioning. The trial also includes comprehensive diagnostic assessments to understand the participants' needs better.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 18 with a diagnosis of autism spectrum disorder and significant disruptive behaviors.
Not a fit: Patients with medical conditions that interfere with participation or those requiring immediate psychiatric attention may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve emotional regulation and reduce disruptive behaviors in adolescents with autism, enhancing their quality of life.
How similar studies have performed: Other studies have shown promise in using behavioral therapies for managing disruptive behaviors in autism, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Boys and girls, ages 12 to 18 years inclusive * Diagnosis of autism spectrum disorder * Presence of disruptive behaviors such as irritability and anger outbursts * No planned changes in the intensity of current treatment(s) * Medication free or on stable medication * Sufficient language for participation in verbal therapy * Lives within driving distance from New Haven, CT Exclusion Criteria: * Presence of a medical condition that would interfere with participation in the study * Presence of a current psychiatric disorder that requires immediate clinical attention
Where this trial is running
New Haven, Connecticut
- Yale Child Study Center — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Denis Sukhodolsky, Ph.D. — Yale University
- Study coordinator: Sydeny Anderson
- Email: sydney.anderson@yale.edu
- Phone: (203) 737-7662
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.