Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 135
Summary
- Conditions
- Advanced Cancer
- Refractory Cancer
- Relapsed Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 3 years and 17 years
- Gender
- Both males and females
Description
Objectives: 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 Ev...
Objectives: 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 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.
Tracking Information
- NCT #
- NCT03765099
- Collaborators
- Human Animal Bond Research Institute
- Investigators
- Principal Investigator: Maryjo Gilmer, PhD Vanderbilt Medical Center