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

• ClinicalTrials.gov Identifier: NCT02323204
• Recruitment Status: Completed
• First Posted: December 23, 2014
• Results First Posted: June 10, 2019
• Last Update Posted: June 10, 2019
• Sponsor: Marizen Ramirez
• Collaborators: The University of Queensland; Children's Mercy Hospital Kansas City; Patient-Centered Outcomes Research Institute; Blank Children's Hospital; Children's Hospitals and Clinics of Minnesota
• Information provided by (Responsible Party): Marizen Ramirez, University of Iowa

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psychological Trauma; Depression; Coping	Behavioral: Link for Injured Kids; Other: So you've been in an accident	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 628 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
• Actual Study Start Date: February 17, 2015
• Actual Primary Completion Date: March 31, 2018
• Actual Study Completion Date: March 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Psychological First Aid; Link for Injured Kids, a form of psychological first aid	Behavioral: Link for Injured Kids; Psychological First Aid
Active Comparator: Trauma Education; Educational materials, "So you've been in an accident" provided to parents.	Other: So you've been in an accident; Educational materials

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• unintentional injury

Exclusion Criteria:

• intentional injury
• non-English speaking families
• children with cognitive impairment.

Contacts and Locations

Locations

United States, Iowa

Blank Children's Hospital

Des Moines, Iowa, United States, 50309

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

United States, Minnesota

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States, 55404

United States, Missouri

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Sponsors and Collaborators

Marizen Ramirez

The University of Queensland

Children's Mercy Hospital Kansas City

Patient-Centered Outcomes Research Institute

Blank Children's Hospital

Children's Hospitals and Clinics of Minnesota

Investigators

• Principal Investigator: Marizen Ramirez, MPH, PhD; University of Iowa

  Study Documents (Full-Text)

Documents provided by Marizen Ramirez, University of Iowa:

Study Protocol  [PDF] May 7, 2018

No Statistical Analysis Plan (SAP) exists for this study.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ramirez MR, Flores JE, Woods-Jaeger B, Cavanaugh JE, Peek-Asa C, Branch C, Bolenbaugh M, Chande V, Pitcher G, Ortega HW, Randell KA, Wetjen K, Roth L, Kenardy J. Comparative Effectiveness of Parent-Based Interventions to Support Injured Children. Pediatrics. 2021 Oct;148(4):e2020046920. doi: 10.1542/peds.2020-046920. Epub 2021 Sep 23.

Pelaez CA, Davis JW, Spilman SK, Guzzo HM, Wetjen KM, Randell KA, Ortega HW, Pitcher GJ, Kenardy J, Ramirez MR. Who Hurts More? A Multicenter Prospective Study of In-Hospital Opioid Use in Pediatric Trauma Patients in the Midwest. J Am Coll Surg. 2019 Oct;229(4):404-414. doi: 10.1016/j.jamcollsurg.2019.05.021. Epub 2019 May 21.

• Responsible Party: Marizen Ramirez, Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT02323204
• Other Study ID Numbers: 201111728; PCORI-1306-02918 ( Other Grant/Funding Number: PCORI )
• First Posted: December 23, 2014
• Results First Posted: June 10, 2019
• Last Update Posted: June 10, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marizen Ramirez, University of Iowa:

posttraumatic stress

Additional relevant MeSH terms:

Wounds and Injuries; Psychological Trauma; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders