10 Participants NeededMy employer runs this trial

Group Behavioral Therapy for Autism

(RT-ID Trial)

GM
Overseen ByGrayson Manley, RN
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Mercy Hospital Kansas City
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist children with autism and an intellectual disability, along with their families, in managing challenging behaviors such as irritability and aggression. The focus is on adapting a program called Regulating Together group therapy to enhance emotional regulation and social outcomes for these children. Suitable participants include children with autism, intellectual disabilities, and frequent emotional outbursts. Participants and their caregivers will attend twice-weekly sessions to learn practical strategies. As an unphased trial, this study provides families with a unique opportunity to access innovative strategies for managing challenging behaviors.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications. The trial requires that any prescribed psychiatric medication and outside behavioral interventions remain stable during the study.

What prior data suggests that this group therapy is safe for children with autism and intellectual disability?

Research has shown that the Regulating Together group therapy is safe for participants. In one study, researchers reported no safety issues. Participants found the program easy to use and expressed satisfaction. Another study found that 93% of participants remained in the program, indicating they did not encounter major problems. Improvements in managing emotions and behavior were observed, which helped reduce hospital visits. Overall, the therapy appears well-tolerated and beneficial for children with autism and intellectual disabilities.12345

Why are researchers excited about this trial?

"Regulating Together" group therapy is unique because it specifically targets emotion dysregulation in children with autism and co-occurring intellectual disabilities, which is an area not thoroughly addressed by current therapies. Traditional treatments often focus on behavioral interventions and medication to manage symptoms, but this therapy emphasizes collaborative emotional regulation between children and their caregivers. Researchers are excited about this approach because it not only aims to improve emotional understanding and management but also strengthens the caregiver-child relationship, potentially leading to more sustainable outcomes.

What evidence suggests that Regulating Together group therapy is effective for autism and intellectual disability?

Research has shown that Regulating Together group therapy, which participants in this trial will receive, may help children with autism and intellectual disabilities manage difficult behaviors. In earlier studies, children who participated demonstrated improvements in their reactions to situations, experienced less irritability, and better controlled their behavior. One study found a 16% reduction in hospital stays for those who received this therapy. Another study reported lower scores on behavior checklists, indicating fewer problem behaviors. Overall, these findings suggest that Regulating Together can effectively help children with autism handle emotional and behavioral challenges.13467

Who Is on the Research Team?

WM

Walker McKinney, PhD

Principal Investigator

Children's Mercy

Are You a Good Fit for This Trial?

This trial is for children who have both autism and intellectual disability, along with issues like irritability or aggression. Their families also participate to help manage these challenging behaviors.

Inclusion Criteria

Child Participant: Meeting clinically significant emotion dysregulation criteria
Child Participant: Use of flexible phrase speech or greater
Child Participant: Fluent in spoken English
See 10 more

Exclusion Criteria

Child Participant: Presence of physical aggression in the child directed towards a peer outside the home resulting in injury within 30 days prior to screening
Child Participant: Other significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior felt to be dangerous or overly disruptive to group sessions reviewed individually by study team
Child Participant: Presence of comorbid major neuropsychiatric illness warranting other treatment approaches
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline

Baseline assessments conducted before the start of the intervention

1 week
1 visit (in-person)

Treatment

Participants receive the Regulating Together intervention for emotion dysregulation, twice per week

5 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Regulating Together group therapy

Trial Overview

The study is testing a group therapy program called Regulating Together, designed to teach practical strategies for managing emotions and behavior in children with autism and intellectual disability. Families take part together in outpatient sessions.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Children with autism and co-occurring intellectual disability and their caregiverExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials
261
Recruited
941,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

Citations

Telehealth regulating together pilot trial: emotion ... - PMC

We observed a 93% retention rate across both groups. Improvements were found in reactivity, irritability, emotion and behavioral regulation,

Emotion Regulation Intensive Outpatient Programming

In this manuscript, we describe the results of a chart review examining a group treatment program designed to address ER deficits in youth with ASD and/or DD.

Emotion regulation and emotion dysregulation in children ...

Children and adolescents with Autism Spectrum Disorder (ASD) often experience challenges in emotion regulation (ER) and emotion dysregulation (ED)

4.

regulatingtogether.com

regulatingtogether.com/evidence/

Evidence

Treatment for ASD Youth. Group Treatment for ASD Youth. Emotion Dysregulation is Substantially Elevated in Autism (513) 803-9291

Regulating Together for Intellectual Disability and Autism: ...

This study will adapt the original Regulating Together curriculum to focus on behavioral interventions to treat emotion dysregulation in Autism ...

Study protocol for a randomized controlled trial of Regulating ...

This is a five-year randomized controlled trial comparing Regulating Together to Achieving Independence and Mastery in School (AIMS), an active control ...

Regulating Together: Caregivers' experiences in a shared ...

The group format reduced isolation, built peer connection, and normalized the shared challenges of raising autistic children.