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NCT05803343 · ClinicalTrials.gov registry record · NA
Evaluating Additive Effects of Including Canines in Regulating Together
A NA study of Autism Spectrum Disorder and Emotion Regulation, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT05803343: Recruiting NA study of Autism Spectrum Disorder and Emotion Regulation, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT05803343 is a NA study of Autism Spectrum Disorder and Emotion Regulation that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 240 participants, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (79% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05803343, a NA study of Autism Spectrum Disorder and Emotion Regulation, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The EDI-R is a parent-report measure that consists of two scales, Reactivity which captures poorly regulated negative emotional responses and Dysphoria characterized by decreased uptake of positive affect and lack of motivation. Higher scores indicate higher emotional reactivity.
Conditions Studied
Interventions
- BEHAVIORAL Regulating Together-Canine
- BEHAVIORAL Regulating Together-Standard
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-02-28 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
What NCT05803343 shows while recruiting
NCT05803343 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (79% higher).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Regulating Together-Canine is the first listed.
NCT05803343 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05803343 about?
NCT05803343 is a clinical study titled "Evaluating Additive Effects of Including Canines in Regulating Together". 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...
What is the current status of trial NCT05803343?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2023-02-28. Estimated completion is 2027-08-31.
What conditions does trial NCT05803343 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Emotion Regulation.
What interventions are being tested in trial NCT05803343?
The interventions under investigation include: Regulating Together-Canine (BEHAVIORAL), Regulating Together-Standard (BEHAVIORAL).
Who is sponsoring clinical trial NCT05803343?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05803343 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05803343's enrollment target sits among peer trials
240 33rd of 224 higher than 191 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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