What side effects are associated with this type of intervention?

Common treatments for emotion regulation in autism spectrum disorder (ASD) include omega-3 fatty acids, sertraline, and gabapentin. Omega-3 fatty acids may cause gastrointestinal distress such as nausea and diarrhea. Sertraline, used for anxiety and agitation, can have side effects like temporary behavioral changes and may require careful dosing. Gabapentin, used for alcohol dependence and other conditions, can cause dizziness, fatigue, and coordination issues. These treatments aim to improve emotional regulation but should be monitored for potential side effects.

What prior FDA approvals exist?

The FDA has approved two medications specifically for the treatment of irritability associated with Autism Spectrum Disorder (ASD): risperidone and aripiprazole. These antipsychotic drugs help manage symptoms such as aggression, self-injury, and severe tantrums. While these medications address behavioral issues, there are no FDA-approved drugs specifically targeting emotion regulation in ASD. The 'Regulating Together' trial aims to improve psychosocial outcomes through emotion regulation interventions, an area not yet covered by existing FDA-approved treatments.

What other types of research exist?

Promising novel alternatives to Regulating Together for autism patients include mindfulness-based interventions, which have emerging support for treating anxiety and mood problems in individuals with autism. Additionally, cognitive-behavioral therapy (CBT) has evidence for use in anxiety and may be adapted for broader emotional regulation. Multimodal individualized physical therapy programs, including applied behavior analysis and sensory-based treatments, may also help improve psychosocial outcomes.

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Regulating Together for Autism

N/A

Recruiting

Led By Rebecca Shaffer

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult

Awards & highlights

Summary

This trial tests a program called Regulating Together, which helps children with autism manage their emotions. It targets kids aged 8-12 who struggle with emotional regulation. The program teaches them to recognize and control their feelings.

Who is the study for?

This trial is for English-speaking caregivers and their children with autism spectrum disorder (ASD) who are 11-12 years old, have functional verbal communication, an IQ score of 65 or higher, and issues with emotion regulation. Families must commit to twice-weekly sessions and keep current medications stable. Children with major sensory impairments, recent psychosocial interventions, a history of serious aggression, or other major neuropsychiatric illnesses are excluded.

What is being tested?

The study aims to validate 'Regulating Together' (RT), an intervention designed to help youth with ASD manage their emotions better compared to 'Achieving Independence and Mastery in School' (AIMS). Participants will attend twice-weekly sessions for either RT or AIMS based on random assignment.

What are the potential side effects?

Since the interventions involve behavioral therapy rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort or fatigue due to the intensity of the therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Emotion Dysregulation Inventory- Reactivity

Secondary study objectives

Children's Organizational Skills Scale (COSS)

Daily Phone Diary

Inpatient Hospitalization Rates

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Regulating Together (RT)Experimental Treatment1 Intervention

Participants will receive Regulating Together -the emotion dysregulation intervention

Group II: Achieving Independence and Mastery in School (AIMS)Active Control1 Intervention

Participants will receive AIMS, the academic functioning/organizational skill intervention.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism, such as Applied Behavior Analysis (ABA), the Early Start Denver Model (ESDM), and the SCERTS program, primarily focus on improving social communication, adaptive behavior, and emotional regulation. These interventions work by using structured, individualized approaches to teach skills and reduce maladaptive behaviors through positive reinforcement and developmental relationship-based techniques. Emotion regulation interventions, like those studied in the Regulating Together trial, aim to help children manage their emotional responses, which is crucial for improving social interactions and overall functioning. These mechanisms are vital for Autism patients as they address core deficits and enhance the ability to navigate daily life more effectively.

Neural Mechanisms of Qigong Sensory Training Massage for Children With Autism Spectrum Disorder: A Feasibility Study.Neurologic treatment strategies in autism: an overview of medical intervention strategies.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

827 Previous Clinical Trials

6,564,303 Total Patients Enrolled

24 Trials studying Autism Spectrum Disorder

10,525 Patients Enrolled for Autism Spectrum Disorder

United States Department of DefenseFED

891 Previous Clinical Trials

332,334 Total Patients Enrolled

18 Trials studying Autism Spectrum Disorder

1,605 Patients Enrolled for Autism Spectrum Disorder

University of Alabama at BirminghamOTHER

1,621 Previous Clinical Trials

2,290,834 Total Patients Enrolled

7 Trials studying Autism Spectrum Disorder

968 Patients Enrolled for Autism Spectrum Disorder

Media Library

Achieving Independence and Mastery in School (AIMS) Clinical Trial Eligibility Overview. Trial Name: NCT05803369 — N/A

Autism Spectrum Disorder Research Study Groups: Achieving Independence and Mastery in School (AIMS), Regulating Together (RT)

Autism Spectrum Disorder Clinical Trial 2023: Achieving Independence and Mastery in School (AIMS) Highlights & Side Effects. Trial Name: NCT05803369 — N/A

Achieving Independence and Mastery in School (AIMS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05803369 — N/A

~57 spots leftby Mar 2026

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