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

NCT05235451 | Completed

• 1 other identifier: IRB #212366
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Animal-Human Bonding; Learning Problem; Child Development

Keywords

Children with learning differences; Animal-assisted intervention

Outcome Measures

Primary Outcomes (5)

• Change in "Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Scale v1.0 - Global Health 7"

  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.

  Day 0, Day 84

• Change in "Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Short Form v1.1 - Depressive Symptoms 6b"

  Child's depressive symptoms before and after the intervention will be measured. This 5-point Likert scale measure (5=Almost Always, 1=Never) includes six items. The final score could range from 6 to 30 and the higher scores mean higher depressive symptoms.

  Day 0, Day 84

• Change in "Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Short Form v2.0 - Anxiety 8a"

  Child's anxiety level before and after the intervention will be measured. This 5-point Likert scale measure (5=Almost Always, 1=Never) includes eight items. The final score could range from 8 to 40 and the higher scores mean higher anxiety level.

  Day 0, Day 84

• Change in "Child reading fluency"

  Copies of teacher evaluations of curriculum-based measure-oral reading fluency (e.g., CBM-ORF) already in use with the students will be obtained to measure reading fluency and comprehension at baseline (T1) and at the end of 12 weeks (T3) in both the intervention and control groups.

  Day 0, Day 84

• Change in "Child acute stress"

  The investigators will measure salivary cortisol of child participants. Trained study staff will obtain salivary swabs from participants in the intervention groups before HAI begins (T1), after 2 weeks (T2), and at the conclusion of the study (T3). Saliva will be obtained and analyzed in the Vanderbilt Hormone Analytical Services Core.

  Day 0, Day 14, Day 84

Secondary Outcomes (1)

• Satisfaction assessment after the intervention

  Day 84

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Human-Animal Interactions

Control group

NO INTERVENTION

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).

Interventions

Human-Animal Interactions OTHER

Human-animal interactions (HAI) is a powerful and cost-effective strategy to improve reading fluencies and comprehension of children with learning differences. Emerging data suggest that HAI help promote classroom behaviors and learning, including effects on cognition, emotional functioning, and motor skills for children with and without learning differences. The HAI reading group will receive reading instruction as usual plus visits from a registered therapy dog team (dog + animal handler) twice a week over 12 weeks.

Intervention group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Eligible Children are:
• years of age
• With or at risk for a learning difference based on teacher report
• Assigned to a small reading group (approximately 3-5 children) that meets at least twice a week
• Able to understand English to complete consents and surveys
• Children both with and without dogs at home are allowed to participate in this study. Parents of subjects will be asked if they have a dog at home and, if so, to describe the child-dog relationship prior to data collection. This factor will be considered throughout the study
• Children taking medications are also allowed to participate in this study, and the investigators will consider medication protocols of subjects when evaluating outcomes.
• Eligible Caregivers are:
• Parent or guardian as determined by person with whom each child resides for \>50% of the time
• years of age and up
• Able to understand English to complete consents and surveys

You may not qualify if:

• Children self-reported fear of or allergies to canines.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Currey Ingram Academy

Brentwood, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Human-Animal Bond

Condition Hierarchy (Ancestors)

Human-Animal Interaction; Behavior

Study Officials

• Terrah F Akard, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 11, 2022
• Study Start: June 20, 2022
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available for sharing no later than the publication date of the main results from the final dataset. Data will be disclosed without a specific deadline.
• Access Criteria: The data will be shared with anyone who is interested in this study. The investigators especially seek to make the data available to the community of scientists interested in human-animal interactions and their impact on children.

Locations

US (1)