๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-07

Evaluating Additive Effects of Including Canines in Regulating Together (NCT05803343)

Evaluating Additive Effects of Including Canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in Youth With Autism Spectrum Disorder

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: Children's Hospital Medical Center, Cincinnati

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD). Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard. Aim 2: Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard. Exploratory Aim: Explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning.

Who can join: Review the eligibility criteria below.

Location: Cincinnati Children's Hospital Medical Center โ€” Cincinnati, Ohio

Age range: 8 Years to 15 Years

๐Ÿงช Interventions in This Study

  • Regulating Together-Canine (BEHAVIORAL)
  • Regulating Together-Standard (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Cincinnati Children's Hospital Medical Center โ€” Cincinnati, Ohio

๐Ÿ“ž Contact the Study Coordinator

Phone: (513) 803-3580

Email: carrie.fassler@cchmc.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—