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

NCT02323204 | Completed Results

• 2 other identifiers: 201111728PCORI-1306-02918
• Study Type: interventional
• Target: 628
• Locations: 1 country
• Sites: 4

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.

Conditions

Psychological Trauma; Depression; Coping

Keywords

posttraumatic stress

Outcome Measures

Primary Outcomes (11)

• Post-traumatic Stress Symptoms (Child Post-traumatic Stress Disorder (PTSD) Scale) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Depressive Symptoms (Center for Epidemiologic Studies Depression Scale (CES-D) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Quality of Life (Questionnaire) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Psychological Distress Symptoms (Kessler Screening Scale for Psychological Distress (K6)) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Strengths and Difficulties (Questionnaire to Assess Internalizing and Externalizing Behaviors (SDQ)) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Emotional Symptoms (SDQ Subscale) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Conduct Problems (SDQ Subscale) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Hyperactivity (SDQ Subscale) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Peer Relationship Problems (SDQ Subscale) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Prosocial Behavior (SDQ Subscale) Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

• Implementation Through the First and Last Survey Administered 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.

  surveys were provided at 6 weeks, 3 months, and 6 months post-baseline

Study Arms (2)

Psychological First Aid

EXPERIMENTAL

Link for Injured Kids, a form of psychological first aid

Behavioral: Link for Injured Kids

Trauma Education

ACTIVE COMPARATOR

Educational materials, "So you've been in an accident" provided to parents.

Other: So you've been in an accident

Interventions

Link for Injured Kids BEHAVIORAL

Psychological First Aid

Psychological First Aid

So you've been in an accident OTHER

Educational materials

Trauma Education

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• unintentional injury

You may not qualify if:

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

Sponsors & Collaborators

• Marizen Ramirez: lead
• The University of Queensland: collaborator
• Children's Mercy Hospital Kansas City: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• Blank Children's Hospital: collaborator
• Children's Hospitals and Clinics of Minnesota: collaborator

Study Sites (4)

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (2)

• 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.

  PMID: 34556547 DERIVED

• 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.

  PMID: 31125609 DERIVED

MeSH Terms

Conditions

Psychological Trauma; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Lost to follow-up is a limitation of this study.

Results Point of Contact

• Title: Dr. Marizen R Ramirez
• Organization: University of Iowa/ University of Minnesota

mramirez@umn.edu

612-624-3143

Study Officials

• Marizen Ramirez, MPH, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 23, 2014
• Study Start: February 17, 2015
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)