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Therapy Dogs + Behavioral Treatment for Autism
N/A
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
Study Summary
This trial will test if using a therapy dog in addition to a behavioral treatment can help children with autism better regulate their emotions.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,351 Total Patients Enrolled
23 Trials studying Autism Spectrum Disorder
10,294 Patients Enrolled for Autism Spectrum Disorder
Rebecca Shaffer, Psy.D.Principal InvestigatorChildren's Hospital Medical Center, Cincinnati
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have major sensory impairments like blindness or severe hearing loss.I have been diagnosed with autism spectrum disorder.My family agrees to not change my medications during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Regulating Together-Canine (RT-Canine)
- Group 2: Regulating Together-Standard (RT-Standard)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants aged 40 and above being accepted for this medical experiment?
"This research project is seeking volunteers aged 8 to 15 years."
Answered by AI
Do I qualify to enroll in this experiment?
"The medical research team is actively seeking 240 participants with a diagnosis of autism, aged between 8 and 15 years old."
Answered by AI
How many participants are being accepted for this research trial?
"Affirmative. Clinicaltrials.gov shows that this research is actively seeking volunteers, which was first posted on February 24th 2023 and recently updated on April 6th 2023. The trial intends to recruit 240 participants at a single medical centre."
Answered by AI
Is enrollment for this research still available to those interested?
"Affirmative, clinicaltrials.gov confirms that the trial is actively enrolling participants. The experiment was initially posted on February 24th 2023 and has been revised recently in April 6th of this same year. A total of 240 individuals must be recruited from 1 site altogether."
Answered by AI
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