Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents
NCT ID: NCT03765099
Last Updated: 2023-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
70 participants
INTERVENTIONAL
2019-02-21
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children
NCT04160013
Mitigating ACEs in Pediatric Primary Care
NCT03058861
Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other
NCT00737035
Problem Solving for Caregivers of Persons With Brain Injury
NCT00164645
Randomized Control Trial of an Animal-Assisted Intervention With Adjudicated Youth
NCT01594606
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Examine the feasibility of animal-assisted interactions sessions for children with a life-threatening condition and primary caregiver to:
* Identify and document modifications for a safe and feasible intervention,
* Obtain recruitment estimates and determine potential recruitment barriers
* Evaluate elements of implementation fidelity (design, training, delivery/receipt of Treatment, enactment)
* Verify safety.
H1-1: Children and parents (\>60%) will complete the interventions and provide positive acceptability data. H1-2: Implementation fidelity can be achieved with the proposed methodology
2. Determine the preliminary efficacy of animal-assisted interactions sessions for:
* Children with a life-threatening condition (LTC) for the outcome of health-related quality of life
* Children with a LTC and their primary caregivers for the outcomes of stress and anxiety
H2-1 Children with a life-threatening condition who receive animal-assisted interactions will experience improved health-related quality of life (HRQOL) more than patients who do not receive animal-assisted interactions.
H2-2a Children with life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.
H2-2b Primary caregivers of children with a life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Animal-Assisted Interactions
Children and their caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.
Animal-Assisted Interactions
Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.
Usual Care
Children and their caregivers randomly assigned to the usual care group will receive usual care which may include play therapy, music therapy or visits with a social worker during their visits to the hospital.
Animal-Assisted Interactions
Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Animal-Assisted Interactions
Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Confirmed diagnosis of relapsed or refractory cancer
Exclusion Criteria
3 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Human Animal Bond Research Institute
UNKNOWN
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maryjo Gilmer
Sponsor Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maryjo Gilmer, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mahoney AB, Akard TF, Cowfer BA, Dietrich MS, Newton JL, Gilmer MJ. Impact of Animal-Assisted Interaction on Anxiety in Children With Advanced Cancer and Their Caregivers. J Palliat Med. 2024 Jan;27(1):75-82. doi: 10.1089/jpm.2023.0091. Epub 2023 Sep 25.
Cowfer BA, Akard TF, Gilmer MJ. Animal-Assisted Interventions for Children with Advanced Cancer: Child and Parent Perceptions. Palliat Med Rep. 2021 Nov 17;2(1):328-334. doi: 10.1089/pmr.2021.0039. eCollection 2021.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VICC PED 18166
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.