Image

DOD Regulating Together Intervention

DOD Regulating Together Intervention

Recruiting
8-12 years
All
Phase N/A

Powered by AI

Overview

Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.

Description

144 children ages 8-12 years old with autism spectrum disorder will be enrolled in the study and randomized to Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS) groups. Participants will complete assessments at five time points: Screen (T1) Week 0

  • where they will complete consent; Baseline (T2); Week 7: Post Active Treatment (includes semi-structured interviews) (T3); Week 16: Post Generalization (T4); Week 29: Final outcome visit (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.

Eligibility

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

Study details
    Autism Spectrum Disorder
    Emotion Regulation

NCT05803369

Children's Hospital Medical Center, Cincinnati

13 April 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.