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NCT02323204 · ClinicalTrials.gov registry record · NA
PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
A NA study of Depression and Psychological Trauma, sponsored by Marizen Ramirez.
- Completed
- Registry status
- NA
- Development phase
- 628
- Enrollment target
- 4
- Study locations
NCT02323204: Completed NA study of Depression and Psychological Trauma, sponsored by Marizen Ramirez.
NCT02323204 is a NA study of Depression and Psychological Trauma that has completed, run by Marizen Ramirez. The registered enrollment target is 628 participants, below the 785-participant average among 679 other Depression trials with a reported enrollment target (20% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02323204, a NA study of Depression and Psychological Trauma, has completed, sponsored by Marizen Ramirez.
- COMPLETED
- Registry status
- NA
- Development phase
- 628 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Post-traumatic stress disorder (PTSD) (modified) scale, a questionnaire. Lower scores are preferable. Scores may range from 1 to 52. Responses submitted by parents are with respect to themselves. Responses submitted by children are with respect to themselves.
Conditions Studied
Interventions
- BEHAVIORAL Link for Injured Kids
- OTHER So you've been in an accident
Study Locations (4)
Iowa
- Blank Children's Hospital - Des Moines
- University of Iowa Hospitals and Clinics - Iowa City
Minnesota
- Children's Hospitals and Clinics of Minnesota - Minneapolis
Missouri
- Children's Mercy Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 628 participants |
| Start Date | 2015-02-17 |
| Est. Completion | 2018-03-31 |
| Phase | NA |
What the finished NCT02323204 record still lists
NCT02323204 is an interventional study that assigns participants to a tested intervention. The registered 628 participants enrollment target is mid-sized for trials with a published cap, below the 785-participant average among 679 other Depression trials with a reported enrollment target (20% lower).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Link for Injured Kids is the first listed.
NCT02323204 reports a single indexed study location in Iowa, Minnesota, Missouri.
Frequently Asked Questions
What is clinical trial NCT02323204 about?
NCT02323204 is a clinical study titled "PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury". 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 ye...
What is the current status of trial NCT02323204?
This trial is currently completed. It is a NA study. The enrollment target is 628 participants. The study started on 2015-02-17. Estimated completion is 2018-03-31.
What conditions does trial NCT02323204 study?
This clinical trial studies the following conditions: Depression, Psychological Trauma, Coping.
What interventions are being tested in trial NCT02323204?
The interventions under investigation include: Link for Injured Kids (BEHAVIORAL), So you've been in an accident (OTHER).
Who is sponsoring clinical trial NCT02323204?
This trial is sponsored by Marizen Ramirez, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02323204 being conducted?
This trial has 4 study locations across Iowa, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02323204's enrollment target sits among peer trials
628 66th of 679 higher than 613 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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