Ignite Creation Date:
2024-05-06 @ 3:36 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02323204
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2012-11-29
Brief Title:
PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
Sponsor:
Marizen Ramirez
Organization:
University of Iowa
Study Overview
Official Title:
PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children presenting to the University of Iowa Health Care System UIHC Blank Childrens Hospital Blank Childrens Hospital of Minneapolis and Kansas City Mercy Childrens 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 11 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 Childrens 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
Aim 1 Assess the feasibility of Link for Injured Kids through qualitative research with parents and providers of previously injured children from UI Childrens 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 childrens 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 Childrens Hospital Using the Iowa Trauma Database Ms Wetjen UIHC Pediatric Nurse Trauma Coordinator will work with Blank Childrens Hospital Pediatric Trauma Coordinator to identify parents whose children previously received an unintentional injury and were treated at the Blank Childrens 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 Childrens 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 05 standard deviation comparing Trauma Education vs Link With an alpha of 005 a sample size of 134 parent-child dyads in each of the arms n268 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 afternoonevening 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 childs medical record to determine if heshe meet eligibility criteria and are going to be admitted A brief information sheet will be included in the patients admission packet describing the study and the potential for participation On a daily basis the research team will review each childs 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 childs 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 childs 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 youve 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 eg levels of depression level of family social support and chi-square tests for categorical outcomes eg 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 eg 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
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 Childrens Hospital Using the Iowa Trauma Database Ms Wetjen UIHC Pediatric Nurse Trauma Coordinator will work with Blank Childrens Hospital Pediatric Trauma Coordinator to identify parents whose children previously received an unintentional injury and were treated at the Blank Childrens 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 Childrens 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 05 standard deviation comparing Trauma Education vs Link With an alpha of 005 a sample size of 134 parent-child dyads in each of the arms n268 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 afternoonevening 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 childs medical record to determine if heshe meet eligibility criteria and are going to be admitted A brief information sheet will be included in the patients admission packet describing the study and the potential for participation On a daily basis the research team will review each childs 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 childs 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 childs 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 youve 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 eg levels of depression level of family social support and chi-square tests for categorical outcomes eg 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCORI-1306-02918 | OTHER_GRANT | PCORI | None |