Emotion regulation intervention for children with autism
Regulating Together: Randomized Controlled Trial Examining Predictors, Facilitators, and Barriers to Treatment Success in Emotion Dysregulation and Autism Spectrum Disorder (ASD)
This study is testing a new program to help children with autism manage their emotions better and see if it improves their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05803369 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on validating the Regulating Together (RT) program aimed at improving psychosocial outcomes for children aged 8-12 with autism spectrum disorder and emotion dysregulation. A total of 144 participants will be randomly assigned to either the RT group or the Achieving Independence and Mastery in School (AIMS) group. The study will involve assessments at five different time points, including pre-treatment and post-treatment evaluations, to measure the effectiveness of the interventions. Each participant will attend twice-weekly 90-minute sessions over a five-week period.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-12 diagnosed with autism spectrum disorder who exhibit signs of emotion dysregulation.
Not a fit: Patients who do not have a diagnosis of autism spectrum disorder or those with a Full Scale IQ score below 65 may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance emotional regulation and overall psychosocial functioning in children with autism.
How similar studies have performed: Previous studies have shown promise in using structured interventions for emotion regulation in children with autism, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of autism spectrum disorder (ASD) * A Full Scale IQ score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II) or other previous Weschler IQ test * Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R). * Caregivers and child are fluent in speaking English * Child functional verbal communication, confirmed via appropriateness for an Autism Diagnostic Observation Schedule (ADOS-2) Module 3. * Family willing to keep prescribed medication and outside interventions stable * willing to participate in twice weekly 90-minute sessions of either Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS). * The guardian must provide written informed consent on behalf of the participant and the participants ages 11-12 years old must provide written informed assent to participate. Exclusion Criteria: * Initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment. * any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury * Presence of comorbid major neuropsychiatric illness warranting other treatment approaches. * Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Shaffer — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Carrie Fassler
- Email: carrie.fassler@cchmc.org
- Phone: 5138033580
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.