Clinical Trial: PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury

Brief 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.


Detailed Summary:

Qualitative Phase I. Aim 1: Assess the feasibility of Link for Injured Kids through qualitative research with parents of previous injured children and social workers and pediatric trauma providers from the the children's hospitals. For phase 1 at UIHC, the investigators will hold focus groups with parents and pediatric health providers at the UIHC. The investigators will work with the Ul Pediatric Trauma Nurse Coordinator (Wetjen) to identify parents whose children were previously injured and treated at the UIHC in the past 12 months. These children are logged into the Trauma Alert system.

UIHC: For the focus groups with providers, the investigators will invite emergency medicine physicians, nurses, pediatric psychiatrists and psychologists to participate in one focus group; and social workers and parent advocates to participate in the second focus groups. Participants identified with the assistance of Ms. Wetjen and Dr. Denning (Research Coordinator, Emergency Medicine) will be provided an introductory email about the study and an information sheet. Those interested in attending will be invited to attend the focus group session during a lunch hour.

Blank Children's Hospital: Using the Iowa Trauma Database, Ms. Wetjen, UIHC Pediatric Nurse Trauma Coordinator will work with Blank Children's Hospital Pediatric Trauma Coordinator to identify parents whose children previously received an unintentional injury and were treated at the Blank Children's Hospital in the past 12 months.

Focus groups will last approximately one hour, and will include open-ended questions about the various types of trauma experienced by children, the kinds of psychosocial consequences encountered by traumatized children, and the types of services perceived as available, accessible and acceptable to fami
Sponsor: University of Iowa

Current Primary Outcome: Post-traumatic Stress Symptoms (Child post-traumatic stress disorder (PTSD) scale) [ Time Frame: Baseline and six months ]

Child post-traumatic stress disorder (PTSD) scale, a questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Depressive symptoms (Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline and six months ]
    Center for Epidemiologic Studies Depression Scale (CES-D), a questionnaire
  • Coping Strategies (Questionnaire) [ Time Frame: Baseline and six months ]
    Questionnaire
  • Pediatric Quality of Life (Questionnaire) [ Time Frame: Baseline and six months ]
    Questionnaire
  • Strengths and Difficulties (Questionnaire to assess internalizing and externalizing behaviors) [ Time Frame: Baseline and six months ]
    Questionnaire to assess internalizing and externalizing behaviors


Original Secondary Outcome: Same as current

Information By: University of Iowa

Dates:
Date Received: November 29, 2012
Date Started: January 2015
Date Completion: February 2018
Last Updated: February 9, 2017
Last Verified: February 2017