N/A
N=628
PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
Psychological Trauma · Depression · Coping
Bottom Line
View on ClinicalTrials.gov: NCT02323204 ↗Enrolled (actual)
628
Serious AEs
—
Results posted
Jun 2019
Primary outcome: Primary: Post-traumatic Stress Symptoms (Child Post-traumatic Stress Disorder (PTSD) Scale) Through the First and Last Survey Administered Post-Baseline — 10.64; 8.53; 9.87; 8.17 units on a scale — p=0.6298
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Link for Injured Kids (Behavioral); So you've been in an accident (Other)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Marizen Ramirez
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-traumatic Stress Symptoms (Child Post-traumatic Stress Disorder (PTSD) Scale) Through the First and Last Survey Administered Post-Baseline |
10.64; 8.53; 9.87; 8.17; 8.88; 7.03 | 0.6298 |
| PRIMARY Depressive Symptoms (Center for Epidemiologic Studies Depression Scale (CES-D) Through the First and Last Survey Administered Post-Baseline |
8.21; 8.84; 7.91; 8.52; 6.90; 7.92 | 0.7893 |
| PRIMARY Quality of Life (Questionnaire) Through the First and Last Survey Administered Post-Baseline |
29.01; 34.87; 27.30; 32.68; 19.71; 21.22 | 0.7166 |
| PRIMARY Psychological Distress Symptoms (Kessler Screening Scale for Psychological Distress (K6)) Through the First and Last Survey Administered Post-Baseline |
5.74; 4.26; 5.34; 4.88; 4.69; 4.05 | 0.6756 |
| PRIMARY Strengths and Difficulties (Questionnaire to Assess Internalizing and Externalizing Behaviors (SDQ)) Through the First and Last Survey Administered Post-Baseline |
9.39; 10.03; 9.12; 9.29; 9.24; 8.37 | 0.1507 |
| PRIMARY Emotional Symptoms (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline |
3.11; 3.14; 3.03; 3.25; 2.62; 2.60 | 0.0654 |
| PRIMARY Conduct Problems (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline |
2.91; 2.79; 2.55; 2.32; 2.80; 2.42 | 0.0286 sig |
| PRIMARY Hyperactivity (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline |
3.98; 4.44; 3.99; 4.27; 4.30; 4.04 | 0.9928 |
| PRIMARY Peer Relationship Problems (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline |
2.66; 2.58; 2.74; 2.46; 2.65; 2.44 | 0.0325 sig |
| PRIMARY Prosocial Behavior (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline |
3.78; 3.34; 3.15; 3.08; 3.58; 3.04 | 0.5824 |
| PRIMARY Implementation Through the First and Last Survey Administered Post-Baseline |
1.10; 1.46; 1.03; 1.22; 0.90; 1.16 | 0.7949 |
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.
Eligibility Criteria
Inclusion Criteria
- unintentional injury
Exclusion Criteria
- intentional injury
- non-English speaking families
- children with cognitive impairment.
Data sourced from ClinicalTrials.gov (NCT02323204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.