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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235451
• Other study ID #: IRB #212366
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: July 21, 2022

Study information

• Verified date: April 2024
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

According to the National Center for Learning Disabilities (NCLD), approximately 2.3 million children in the United States have learning differences (LD) such as dyslexia or ADHD. Despite improvement in educational interventions such as resource-room services and instructional styles, the availability of services to help these children and their families cope, adapt, and maintain quality of life (QOL) is inadequate. In particular, children with LD are especially at high risk for negative consequences, including both physical and mental health issues compared with typically developing children. Human-animal interactions (HAI) may be a powerful and cost-effective strategy to improve reading fluencies and comprehension of children with LD. 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 LD. Yet, empirical evidence using a rigorous approach to support the effectiveness of HAI with children with or at risk for LD is lacking. Previous studies endorse the effectiveness of HAI in promoting reading abilities and show promise to improve psychosocial outcomes for children, but have focused on typically developing children. No published studies have specifically targeted effects of HAI on children with or at risk for learning differences. More data are needed to substantiate positive effects on reading abilities associated with HAI. The long-term goal of this study is to improve reading abilities and reduce the negative psychological and social sequelae of children with learning differences (LD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 21, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

<Inclusion Criteria>

Eligible Children are:

• 5-12 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

• 18 years of age and up

• Able to understand English to complete consents and surveys

<Exclusion Criteria>

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

Related Conditions & MeSH terms

• Child Development
• Learning Disabilities

Intervention

Other:
• Human-Animal Interactions
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.

Locations

Country	Name	City	State
United States	Currey Ingram Academy	Brentwood	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Satisfaction assessment after the intervention	End-of-study interviews will be conducted with children and parents in the intervention group to assess their satisfaction with the HAI.	Day 84