PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
Condition: Psychological Trauma; Depression; Coping
MeSH terms: Wounds and Injuries; Psychological Trauma
Study type: Interventional

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.

      Phase II: Randomized Controlled Trial.

      Aim 2: Through a randomized trial, determine the range of potential psychosocial and
      behavioral health indicators possibly impacted by the newly developed Link for Injured Kids
      program. This will identify the types of outcomes which could include PTSD, depression,
      nonspecific distress, quality of life, absenteeism, school performance, coping skills,
      communication skills, and access to mental health.

      Eligibility: Children with unintentional injuries will be recruited to participate in the
      randomized trial. Children will be administered the Children's Orientation and Amnesia Test
      (COAT), which is a measure of orientation to self, place and memory, and those that pass the
      COAT with a score of at least 55 out of a possible 65 points, will be recruited into the
      study. One parent of the child will be recruited for participation. Children with intentional
      injuries will be excluded from the study. Inclusion and exclusion criteria are the same for
      both randomization groups. Exclusions include non-English speaking, diagnosis of intellectual
      deficit or psychosis, suicide attempt in the last year, and residential treatment placement
      in the last year.

      Sample Size. The investigators conducted sample size based on testing a moderate effect size
      of 0.5 standard deviation comparing Trauma Education vs Link. With an alpha of 0.05, a sample
      size of 134 parent-child dyads in each of the arms (n=268) has 100% power to examine
      comparisons. The investigators will oversample by 12% for a total n = 300.

      Recruitment, Screening and Randomization.

      The research team will review patient admission records morning and afternoon/evening to
      identify eligible patients (unintentional injury admissions between 10-17 years of age). The
      team will determine if the child meets inclusion criteria by reviewing information collected
      from EPIC, the electronic health record system at UIHC.

      A study team member will be texted if a child is admitted and meets eligibility criteria. The
      text will not contain identifying information, just a text like "A patient is added to the
      database." The research team will review the child's medical record to determine if he/she
      meet eligibility criteria and are going to be admitted. A brief information sheet will be
      included in the patient's admission packet describing the study and the potential for
      participation. On a daily basis, the research team will review each child's medical record to
      determine when the child is likely to be discharged. On the day of discharge or any
      convenient time recommended by the provider, a member of the research team will present to
      the child's room to determine if the child has an appropriate level of consciousness to
      complete the consent process (an orientation score of at least 55), and if appropriate
      recruit the dyad. The team member will discuss the study and complete the consent process
      with the dyad in-person. To minimize the possibility of coercion during the consent process,
      the research team will follow the consent document closely and stress to the dyad that the
      child's health care will not be affected by participation in the study.

      Randomization. After enrollment, each family will be randomly assigned on a rolling basis to
      either the Link or trauma education arms of the study.

      Intervention Training. Parents randomized to the intervention arm will be trained to offer
      Link to their child as needed. A 20 to 45 minute training session will be offered at the ED
      or in-patient ward in a private consultation room by a member of the research team. In
      addition, the investigators will offer training, if desired, at another location outside the
      hospital during a convenient time. A training manual will be offered to the family. The steps
      of Link will be taught.

      In Link 1, the parents will be taught to use reflective listening skills based on
      motivational interviewing to obtain information without invasive probing (found to be harmful
      in the practice of Critical Incident Stress Debriefing). Additionally, the parent will
      briefly assess current emotional response to the crisis using the modified Kessler-6
      screener, a six-item tool that asks about feelings of sadness, nervousness, restlessness,
      hopelessness, effort, and worthlessness. In Link 2, the psychological first aid
      interventionist facilitates access to resources and further care if necessary to support
      their child. Resources are given to the family including a toll-free help line and support
      for advanced mental health care at UIHC and their local community.

      Trauma Education families will not be trained but be given a parent booklet, "So you've been
      in an accident."

      Data Collection.

      Data about the injury visit and follow-up visits will be collected from each enrolled child
      from the medical records. The investigators will collect nature of injury and body location
      using the International Classification of Diseases (ICD-9). Additional information collected
      will include length of stay, diagnostic procedures, mechanism of injury, initial vital signs,
      and any follow-up complications or co-morbidities. Information on injury severity will be
      recorded through the collection of abbreviated injury scale (AIS) and injury severity scale
      (ISS) scores.

      Baseline, 6-week, 3-month and 6-month surveys will be administered with parents and children
      in both Link and Trauma Education arms. The investigators will ask the child and parent to
      complete baseline surveys in the patient ward. Follow-up 6-week, 3-month and 6-month surveys
      will be conducted by self-administered mailed surveys or online. Questionnaires will measure
      depressive symptoms, symptoms of post traumatic stress disorder, social support, family
      communication, strengths and difficulties and quality of life and asks about any mental
      health or community resources they may have used since the last questionnaire. For follow-up,
      the research team will e-mail a link for the parent and the child to complete their surveys
      as well as mail a hard copy version of the questionnaire with a cover letter explaining that
      the survey can be completed on paper or online and a postage paid envelope. If completed
      online, the questionnaires will be done electronically using REDCap, a U of I supported
      online survey system. A telephone call will be placed to the dyad the day the hard copy
      questionnaire is mailed informing the dyad of the mailing.

      If an online or mailed questionnaire is not returned within 10 days the research team will
      attempt to contact the dyad by phone 6 times within a month to remind them of the
      questionnaire. After a month of no response, the investigators will resend the package or
      online link. If a dyad does not complete the 6-week questionnaire, they will still be asked
      to complete the 3-month and 6-month questionnaires.

      Analytic Plan

      The investigators will compare the effectiveness of the two intervention arms (Link and
      Trauma Education) to each other. The research team will examine several parent-related and
      child-related outcomes potentially impacted by the interventions, including symptoms of PTSD
      and depression, coping, family social support, quality of life, school outcomes, and contacts
      with mental health professionals. Outcomes may be continuous or categorical in nature. A
      number of comparisons will involve repeated measures of subjects (child or parent) across
      time.

      The investigators will first calculate t-tests and Wilcoxon rank sum tests to examine
      continuous outcomes (e.g., levels of depression, level of family social support), and
      chi-square tests for categorical outcomes (e.g., symptomatic for PTSD vs. asymptomatic). If
      randomization is not achieved, the investigators will pursue Generalized Linear Mixed Models
      (GLMM). As an example, for PTSD symptoms, the research team will examine 1) onset of symptoms
      at six weeks, and 2) changes measured from six weeks to three months and to six months. 1)
      For six-week measurements, the investigators will conduct a simple generalized linear model
      and include time-varying covariates to account for measures changed from baseline (e.g.,
      coping, social support). 2) For changes from six weeks through six months, the GLMMs will
      account for clustering of repeated observations clustered within subjects over time.
    

Intervention name(s): Link for Injured Kids; So you've been in an accident
Intervention type(s): Behavioral; Other
Intervention description(s): Psychological First Aid; Educational materials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: posttraumatic stress