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NCT05235451 · ClinicalTrials.gov registry record · NA

Human-Animal Interactions to Improve Reading for Children With Learning Differences

A NA study, sponsored by Vanderbilt University.

Completed
Registry status
NA
Development phase
14
Enrollment target

NCT05235451: Completed NA study, sponsored by Vanderbilt University.

NCT05235451 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05235451, a NA study, has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
NA
Development phase
14 participants
Enrollment target

Study Summary

The overall purpose of this study is to determine feasibility and preliminary efficacy of pet therapy, or human-animal interactions (HAI), for children (5-12 years of age) with or at risk for LD. Children among 4 reading groups will be randomly assigned to a HAI intervention or control group. The 2 HAI intervention reading groups will receive visits from a registered canine team during children's small group reading sessions twice a week over 12 weeks. The 2 control reading groups will receive care as usual and offered a 1-time visit from the dog at the end of the study (after T3 completed). Two weeks of initial work will focus on preliminary modifications to the protocol. Parents will complete electronic measures of psychological outcomes (child depression, anxiety, QOL) via REDCap at baseline (T1), 2 weeks post-baseline (T2), and 12 weeks post-baseline (T3). The investigators will obtain copies of reading assessments already conducted by the teachers at T1 and T3. Children's salivary cortisol will be obtained from participants in the intervention groups at T1, T2, and T3. Children and their parents will complete concluding interviews at study end (T3) to further inform what they liked and did not like about the intervention. Results of the proposed study will provide critical data for a future full-scale randomized clinical trial (R01) to examine the impact of HAI on psychological, physiological, and reading outcomes in children with or at risk for LD.

Primary Outcome

Child's overall quality of life before and after the intervention will be measured. This 5-point Likert scale measure (5=Excellent, 1=Poor) includes seven items. The final score could range from 7 to 35 and the higher scores mean higher quality of life.

Interventions

  • OTHER Human-Animal Interactions

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2022-06-20
Est. Completion 2022-07-21
Phase NA
Vanderbilt University

430 total trials

What the finished NCT05235451 record still lists

NCT05235451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Human-Animal Interactions is the first listed.

NCT05235451 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05235451 about?

NCT05235451 is a clinical study titled "Human-Animal Interactions to Improve Reading for Children With Learning Differences". The overall purpose of this study is to determine feasibility and preliminary efficacy of pet therapy, or human-animal interactions (HAI), for children (5-12 years of age) with or at risk for LD. Children among 4 reading groups will be randomly assigned to a HAI intervention or control group. The 2 ...

What is the current status of trial NCT05235451?

This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2022-06-20. Estimated completion is 2022-07-21.

What interventions are being tested in trial NCT05235451?

The interventions under investigation include: Human-Animal Interactions (OTHER).

Who is sponsoring clinical trial NCT05235451?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05235451's enrollment target sits among peer trials

14 1909th of 2000 higher than 90 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05235451, the US trial registry maintained by the National Library of Medicine. NCT05235451 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.