Human-Animal Interactions to Improve Reading for Children With Learning Differences
Primary Purpose
Animal-Human Bonding, Learning Problem, Child Development
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Human-Animal Interactions
Sponsored by
About this trial
This is an interventional supportive care trial for Animal-Human Bonding focused on measuring Children with learning differences, Animal-assisted intervention
Eligibility Criteria
<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.
Sites / Locations
- Currey Ingram AcademyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05235451
First Posted
January 20, 2022
Last Updated
February 24, 2023
Sponsor
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT05235451
Brief Title
Human-Animal Interactions to Improve Reading for Children With Learning Differences
Official Title
Human-Animal Interactions to Improve Reading for Children With or at Risk for Learning Differences
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Animal-Human Bonding, Learning Problem, Child Development
Keywords
Children with learning differences, Animal-assisted intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Human-Animal Interactions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in "Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Scale v1.0 - Global Health 7"
Description
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.
Time Frame
Day 0, Day 84
Title
Change in "Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Short Form v1.1 - Depressive Symptoms 6b"
Description
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.
Time Frame
Day 0, Day 84
Title
Change in "Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Short Form v2.0 - Anxiety 8a"
Description
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.
Time Frame
Day 0, Day 84
Title
Change in "Child reading fluency"
Description
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.
Time Frame
Day 0, Day 84
Title
Change in "Child acute stress"
Description
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.
Time Frame
Day 0, Day 14, Day 84
Secondary Outcome Measure Information:
Title
Satisfaction assessment after the intervention
Description
End-of-study interviews will be conducted with children and parents in the intervention group to assess their satisfaction with the HAI.
Time Frame
Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
<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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Terrah F Akard, PhD
Phone
615-343-6025
Email
terrah.akard@vanderbilt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eunji Cho, PhD
Phone
615-343-1471
Email
eunji.cho@vanderbilt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrah F Akard, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Currey Ingram Academy
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Barton, Ed.D
Phone
615-507-3200
Email
danielle.barton@curreyingram.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
There are no tangible resources to share at this time as the intervention is in testing phases. The investigators plan to make the intervention available for sharing in the future, upon completed testing. Therefore, data is the only resource available for sharing.
The proposed research will produce data with 40 children with or at risk for learning differences. The final data set will contain demographic information and children's psychological distress, acute stress, and reading fluency after the human-animal interaction.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Human-Animal Interactions to Improve Reading for Children With Learning Differences
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