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

Study results available
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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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02323204 on ClinicalTrials.gov