NCT05235451

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

Completed NA Last updated 22 April 2024

What this trial tests

NA trial testing Human-Animal Interactions in Animal-Human Bonding in 14 participants. Completed in 21 July 2022.

Timeline

20 June 2022

Primary endpoint
21 July 2022

21 July 2022

Quick facts

Lead sponsor	Vanderbilt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	14
Start date	20 June 2022
Primary completion	21 July 2022
Estimated completion	21 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Human-Animal Interactions

Conditions studied

• Animal-Human Bonding — all drugs for Animal-Human Bonding →
• Learning Problem — all drugs for Learning Problem →
• Child Development — all drugs for Child Development →

Sponsor

Vanderbilt University

Who can join

Adults 5 to 12, any sex, with Animal-Human Bonding or Learning Problem. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.