What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions, pharmacologic treatments, and complementary and alternative therapies. Behavioral interventions, such as Applied Behavior Analysis (ABA), generally have minimal side effects but can be intensive and demanding for both children and families. Pharmacologic treatments, like antipsychotics (e.g., risperidone), may cause weight gain, drowsiness, and metabolic changes. Complementary therapies, such as omega-3 fatty acid supplementation, typically have mild side effects like gastrointestinal distress. Animal-Assisted Interventions (AAI), which aim to enhance emotional regulation and engagement, are generally well-tolerated, though potential risks include allergies, infections, or injuries from animal interactions.

What prior FDA approvals exist?

The FDA has approved two medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD): risperidone and aripiprazole. These medications are primarily used to manage symptoms such as aggression, self-injury, and severe tantrums. There are no FDA-approved drugs specifically for enhancing emotional regulation and engagement through interaction with animals, as seen in Animal-Assisted Interventions (AAI). Current pharmacologic treatments focus on managing behavioral symptoms rather than directly addressing emotional regulation or engagement.

What other types of research exist?

Promising alternatives to Animal-Assisted Intervention (AAI) for Autism Spectrum Disorder patients include: 1) Augmentative communication strategies such as the Picture Exchange Communication System (PECS) and other flexible communication systems using personal computers and mobile devices. 2) Social skills instruction through structured social skills groups, which have shown evidence of improving social competence and friendship quality. 3) Early and intensive behavioral-based interventions and developmental models, which are associated with better outcomes when provided with high staff-to-student ratios, individualized programming, and family involvement.

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Therapy Dogs + Behavioral Treatment for Autism

Phase 2

Recruiting

Led By Rebecca Shaffer, Psy.D.

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 through study completion

Awards & highlights

Summary

This trial is testing if having a dog in therapy sessions can help children with autism manage their emotions better. It targets kids aged 8 to 15 who struggle with emotional control. The idea is that dogs can make therapy more enjoyable and less stressful, aiding in emotional learning. Using dogs in therapy is a growing practice in autism therapy, often involving dogs to help improve emotional and behavioral outcomes.

Who is the study for?

This trial is for children with autism spectrum disorder (ASD) who have issues with emotion regulation, confirmed by specific tests and assessments. They must be on stable medication, have an IQ score of 65 or higher, and speak English as their primary language. Children allergic to dogs, with a fear of canines, history of aggression towards animals or other children causing injury recently are excluded.

What is being tested?

The study is testing if adding therapy dogs to a behavior treatment program called Regulating Together helps kids with ASD manage their emotions better than the standard program without dogs. It also looks at whether this makes kids more engaged and improves learning.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, there may be risks associated with interaction between children and canines which will be monitored throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion 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 (EDI-R)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Regulating Together-Canine (RT-Canine)Experimental Treatment1 Intervention

Participants in this Arm will receive the Regulating Together-Canine intervention.

Group II: Regulating Together-Standard (RT-Standard)Active Control1 Intervention

Participants in this Arm will receive the Regulating Together-Standard 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 Spectrum Disorder (ASD) include behavioral and educational interventions, such as the Early Start Denver Model (ESDM) and the SCERTS program, which focus on improving social communication, adaptive behavior, and cognitive skills through structured, individualized approaches. Animal-Assisted Interventions (AAI), like therapeutic horseback riding and canine-assisted therapy, enhance emotional regulation and engagement by providing sensory and social stimuli that can reduce stress and improve social behaviors. Augmentative communication strategies, such as the Picture Exchange Communication System (PECS), help nonverbal children communicate more effectively, reducing frustration and promoting social interaction. These treatments are essential for ASD patients as they address core symptoms and improve overall quality of life by fostering better communication, social skills, and emotional well-being.

Replication Pilot Trial of Therapeutic Horseback Riding and Cortisol Collection With Children on the Autism Spectrum.Animal-Assisted Therapies for Youth with or at risk for Mental Health Problems: A Systematic Review.

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Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

827 Previous Clinical Trials

6,564,207 Total Patients Enrolled

24 Trials studying Autism Spectrum Disorder

10,429 Patients Enrolled for Autism Spectrum Disorder

Rebecca Shaffer, Psy.D.Principal InvestigatorChildren's Hospital Medical Center, Cincinnati

Media Library

Regulating Together-Canine Clinical Trial Eligibility Overview. Trial Name: NCT05803343 — Phase 2

Autism Spectrum Disorder Research Study Groups: Regulating Together-Canine (RT-Canine), Regulating Together-Standard (RT-Standard)

Autism Spectrum Disorder Clinical Trial 2023: Regulating Together-Canine Highlights & Side Effects. Trial Name: NCT05803343 — Phase 2

Regulating Together-Canine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05803343 — Phase 2

~156 spots leftby Aug 2027

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