Animal-Human BondingNCT05235451
Human-Animal Interactions to Improve Reading for Children With Learning Differences
A study testing Human-Animal Interactions in people with Animal-Human Bonding and Learning Problem, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Animal-Human Bonding, Learning Problem, Child Development
- What is being tested?
- Human-Animal Interactions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 21 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
<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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human-Animal Interactions to Improve Reading for Children With or at Risk for 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 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.
Read the 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).
- Conditions
- Animal-Human Bonding, Learning Problem, Child Development
- Being tested
- Human-Animal Interactions
- Keywords
- Children with learning differences, Animal-assisted intervention
- Medical subject headings
- Human-Animal Bond
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human-Animal InteractionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, Day 14, Day 84
Secondary outcomes (1)
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.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start20 Jun 2022
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Animal-Human BondingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terrah Akard, Vanderbilt University
- Investigators
- Terrah F Akard, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235451
- Sponsor's protocol ID
- IRB #212366
- Status last verified
- Apr 2024
- First submitted
- 20 Jan 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human-Animal Interactions to Improve Reading for Children With or at Risk for Learning Differences
- ClinicalTrials.gov ID
- NCT05235451
- Acronym / sponsor ID
- IRB #212366
- Conditions
- Animal-Human Bonding, Learning Problem, Child Development
- Keywords
- Children with learning differences, Animal-assisted intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Human-Animal InteractionsThe 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. |
| 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). |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human-Animal InteractionsHuman-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. | Other | Intervention group |
Primary outcome
Change in "Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Scale v1.0 - Global Health 7"
Time frame: Day 0, Day 84
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"
Time frame: Day 0, Day 84
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"
Time frame: Day 0, Day 84
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"
Time frame: Day 0, Day 84
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"
Time frame: Day 0, Day 14, Day 84
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.
1 secondary outcome
Satisfaction assessment after the intervention
Time frame: Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrah F Akard, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human-Animal Interactions in people with Animal-Human Bonding and Learning Problem, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in "Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Scale v1.0 - Global Health 7" (time frame: Day 0, Day 84). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.