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NCT05803343
Evaluating Additive Effects of Including Canines in Regulating Together
NA trial testing Regulating Together-Canine in Autism Spectrum Disorder in 240 participants. Currently enrolling.
31 August 2027
Quick facts
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 28 February 2023 |
| Primary completion | 31 August 2027 |
| Estimated completion | 31 August 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Regulating Together-Canine
- Regulating Together-Standard
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Emotion Regulation — all drugs for Emotion Regulation →
Sponsor
Children's Hospital Medical Center, Cincinnati
Who can join
Adults 8 to 15, any sex, with Autism Spectrum Disorder or Emotion Regulation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05803343
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05803343 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
- Last refreshed: 18 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05803343.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing