PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
NCT02323204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 628
Last updated 2019-06-10
Summary
Children presenting to the University of Iowa Health Care System (UIHC), Blank Children's Hospital (Blank), Children's Hospital of Minneapolis, and Kansas City Mercy Children's Hospital with an injury resulting in admission will be the sample population. A child will be included if they are 10-17 years old with an unintentional injury. Consenting children and their parents will be asked to complete a series of four questionnaires: before hospital discharge, at 1-month post discharge, 3-months and 6-months post discharge. The parent-child dyads will be randomized (1:1) to receive 1) training in Link for Injured Kids or 2) Trauma Education. The survey completed in the hospital will be a paper survey or online via an iPad, and follow-up surveys can be completed on paper or online.
Aim #1: Assess the feasibility of Link for Injured Kids through qualitative research with parents and providers of previously injured children from UI Children's Hospital.
Aim #2: Through a randomized trial, determine the range of potential psychosocial and behavioral health indicators possibly impacted by Link for Injured Kids. This will identify the types of outcomes which could include post-traumatic stress disorder (PTSD), depression, nonspecific distress, quality of life, absenteeism, school performance, coping skills, communication skills, and access to mental health.
Conditions
- Psychological Trauma
- Depression
- Coping
Interventions
- BEHAVIORAL
-
Link for Injured Kids
Psychological First Aid
- OTHER
-
So you've been in an accident
Educational materials
Sponsors & Collaborators
-
The University of Queensland
collaborator OTHER -
Children's Mercy Hospital Kansas City
collaborator OTHER -
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Blank Children's Hospital
collaborator OTHER -
Children's Hospitals and Clinics of Minnesota
collaborator OTHER -
Marizen Ramirez
lead OTHER
Principal Investigators
-
Marizen Ramirez, MPH, PhD · University of Iowa
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-17
- Primary Completion
- 2018-03-31
- Completion
- 2018-03-31
Countries
- United States
Study Locations
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