PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 628
- Locations
- 8
- Primary Endpoint
- Post-traumatic Stress Symptoms (Child Post-traumatic Stress Disorder (PTSD) Scale) Through the First and Last Survey Administered Post-Baseline
Study Overview
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 Description
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 families particularly from rural Iowa. During the focus groups, participants will be provided a copy of the LPC for Injured Kids manual, and feedback will be solicited from participants about the content of the intervention and its applicability to families from rural Iowa.
As a qualitative study, the sample will be adaptive and purposeful. The investigators anticipate holding the focus group with 6-10 participants. All sessions will be audiotaped and transcribed. Analysis will involve qualitative coding, content analysis, and triangulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •unintentional injury
Exclusion Criteria
- •intentional injury
- •non-English speaking families
- •children with cognitive impairment.
Arms & Interventions
Psychological First Aid
Link for Injured Kids, a form of psychological first aid
Intervention: Link for Injured Kids (Behavioral)
Trauma Education
Educational materials, "So you've been in an accident" provided to parents.
Intervention: So you've been in an accident (Other)
Outcomes
Primary Outcomes
Post-traumatic Stress Symptoms (Child Post-traumatic Stress Disorder (PTSD) Scale) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
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.
Depressive Symptoms (Center for Epidemiologic Studies Depression Scale (CES-D) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Center for Epidemiologic Studies Depression Scale (CES-D) (modified), a questionnaire. Lower scores are preferable. Scores may range from 1 to 31. Responses submitted by parents are with respect to themselves. Responses submitted by children are with respect to themselves.
Quality of Life (Questionnaire) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Quality of Life, a questionnaire (modified). Lower scores are preferable. Scores may range from 1 to 101. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.
Psychological Distress Symptoms (Kessler Screening Scale for Psychological Distress (K6)) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Psychological Distress Symptoms (Kessler Screening Scale for Psychological Distress (K6)) (modified). Lower scores are preferable. Scores may range from 1 to 25. Responses submitted by parents are with respect to themselves. Responses submitted by children are with respect to themselves.
Strengths and Difficulties (Questionnaire to Assess Internalizing and Externalizing Behaviors (SDQ)) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Strengths and Difficulties (Questionnaire to Assess Internalizing and Externalizing Behaviors (SDQ)) (modified). Lower scores are preferable. Scores may range from 1 to 41. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.
Emotional Symptoms (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Emotional Symptoms (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.
Conduct Problems (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Conduct Problems (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.
Hyperactivity (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Hyperactivity (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.
Peer Relationship Problems (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Peer Problems (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.
Prosocial Behavior (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Prosocial Behavior (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.
Implementation Through the First and Last Survey Administered Post-Baseline
Time Frame: surveys were provided at 6 weeks, 3 months, and 6 months post-baseline
Implementation was measured on a scale ranging from 0 to 2, where a score of 0 is indicative of no implementation, a score of 1 indicative of partial implementation, and 2 of full implementation. For the trauma education group, a score of 0 was assigned if the subject never read the provided materials, a score of 1 was assigned if participants read but did not use the provided materials, and a score of 2 was assigned if the participant read and used the material at least once. For the link group, a score of 0 was assigned if the subject did not use any of the skills associated with the intervention, a score of 1 was assigned if at least one but not all three skills were used, and a score of 2 was assigned if all skills were used.
Secondary Outcomes
No secondary outcomes reported
Investigators
Marizen Ramirez
Associate Professor
University of Iowa