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Completed

NCT Number: NCT05235451

Human-Animal Interactions to Improve Reading for Children With 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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Currey Ingram Academy

Brentwood, Tennessee, 37027, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

<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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Satisfaction assessment after the intervention

    Time frame: Day 84

    End-of-study interviews will be conducted with children and parents in the intervention group to assess their satisfaction with the HAI.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2022
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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