Posttraumatic Stress DisorderNCT02299583
Controlled Trial of Early Intervention With Children and Adolescents Exposed to Nonrelational Traumatic Events
A study testing Preventive intervention trauma-informed early intervention in people with Posttraumatic Stress Disorder and Depression, run by Carolina Magdalene Maier at 1 site in Denmark.
Trial summary
Background: International studies have shown that a substantial number of children and adolescents are exposed to potentially traumatic events. Many of these children and adolescents, some of whom will experience posttraumatic stress disorder (PTSD), are submitted to health care departments shortly after exposure as… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression, Anxiety
- What is being tested?
- Preventive intervention trauma-informed early intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 8 and 18 years
- Admission to hospital for accidental injury involving danger to life, serious injury or impairment
- Admission to hospital for acute illness involving danger to life, serious injury or impairment
- Sudden severe impairment of medical condition
- Admission of parent or sibling to hospital for accidental injury involving danger to life, serious injury or impairment
- Admission of parent or sibling to hospital for acute illness involving danger to life, serious injury or impairment
- Sudden severe impairment of parental or sibling medical condition
- Consent to participate in the study
Who cannot join
- Parent's Danish insufficient for questionnaire completion
- Developmental delay or mental retardation in the child
- Moderate to severe head injury or posttraumatic amnesia following the accident
- Injury due to physical or sexual abuse (intentional injury)
Trial locations and contacts
1 site in 1 country.
Carolina M Maier, MSc contact
Denmark1 site, 1 recruiting
- Recruiting
Hospitals of the Capitol Region of Denmark
Copenhagen
About this study
Official title: Protocol for a Controlled Trial of Early Intervention With Children and Adolescents Exposed to Nonrelational Traumatic Events Comparing Trauma-informed and Usual Health Care Practice
Background: International studies have shown that a substantial number of children and adolescents are exposed to potentially traumatic events. Many of these children and adolescents, some of whom will experience posttraumatic stress disorder (PTSD), are submitted to health care departments shortly after exposure as the most common types of traumatic events are accidental injury, serious somatic illness or death of someone close. There has been some research on early psychological interventions for prevention and treatment of PTSD. However, very little research has examined the efficacy of trauma-informed practice among health care professionals (HCPs). The present trial aims to evaluate and compare trauma-informed health care with usual practice.
Methods/Design: The primary clinical question under investigation is the efficacy of an early, trauma-informed intervention for the prevention of PTSD in children and adolescents following exposure to a potentially traumatic event. The trail compares a standardized trauma-informed practice with usual care (no intervention) in health care departments receiving children and adolescents after exposure to determine if trauma-informed care is associated with a reduction in psychological outcome measures over time. Specifically, the investigators examine the efficacy of health care professional's active use of trauma-informed standards of action and a trauma training program for HCPs in the intervention group. The primary outcome will be a reduction in trauma, anxiety and depressive symptoms on self-reports in the active intervention compared to usual care.
Discussion: This trial will be the first controlled trial to examine a trauma-informed intervention carried out by HCPs. It will provide the first evidence on the efficacy of health care delivered by trauma-educated HCPs using trauma-informed standards of action. A successful implementation of this protocol will support the thesis that prevention of PTSD among children and adolescents benefits from a focus on the practice of HCPs. If efficacious, the results will be a call for future research to extend the investigation of interventions from psychological treatment to HCP-based care.
Read the detailed description
Background
A significant number of children and adolescents have been exposed to potentially traumatic events (PTEs). American and Australian studies report a prevalence of about 20-25% of high magnitude traumatic events among adolescents. A Danish study of four Nordic countries found that 90 % of adolescents with a mean age of 14.5 years had been exposed to at least one low magnitude traumatic event.
A potentially traumatic event may be either relational such as sexual or physical abuse or nonrelational such as illness, motor vehicle accident or fire. The incidence of nonrelational trauma is very high in children and adolescents with accidental injuries being the largest cause of morbidity and mortality among children in the United States as well as in Denmark. Although many children and adolescents demonstrate great resilience or appear to be only briefly affected by nonrelational traumatic events a significant minority of young people will develop posttraumatic stress disorder (PTSD), posttraumatic stress symptoms (PTSSs) or other psychological difficulties following exposure to trauma.
Accidental injury is the most common type of trauma. Researchers report prevalence rates of PTSD among children and adolescents in road traffic accidents ranging from 6% to 35%. Rates of PTSSs (also termed subclinical, subthreshold or partial PTSD) range from 11% to 50%6-14. These rates are important since recent research has indicated only minor differences in terms of distress and impairment between children meeting full and partial criteria for PTSD.
The diagnosis of medical illness such as cancer or diabetes has also been shown to cause PTSD in some children and adolescents with prevalence rates of 5.4% for diabetes and of 10% to 18% for cancer. A recent meta-analysis of prevalence related to both injury and illness reported average prevalence rates of PTSD related to injury ranging from 0% to 37.5%, with a mean of 19.82%, and rates in ill youth ranging from 0% to 32%, with a mean of 12.04%.
Preventive interventions for children and adolescents
Given the high prevalence rates of exposure and the likewise high prevalence rates of PTSD and PTSSs after PTEs there is a pressing need for preventive interventions that decrease the risk of PTSD. In a recent systematic review by Forman-Hoffman et al. (2013) of interventions for children exposed to nonrelational traumatic events 6 different interventions based exclusively on exposure were identified. These included trauma-focused cognitive-behavioural therapy child and family traumatic stress intervention (CFTSI), 2 different school interventions with elements of CBT, early psychological intervention and a propranolol study. The two latter studies found no improvement in outcomes, the remaining 4 interventions found some improvement with regards to PTSD, severity of PTSD and PTSSs.
Another recent meta-analysis by Kramer (2011) reviewing early psychological interventions in children and adolescents after single trauma included seven studies (two of which reappeared in the above mentioned review). These included CFTSI, school-based interventions, early psychological interventions, and two interventions based exclusively on psychoeducational information provision. The authors concluded that intervention effects regarding PTSSs and PTSD were small or non-significant but found promising beneficial tendencies with regards to dissociation, anxiety and, to some extent, arousal.
Overall, the empirical literature has not supported the effectiveness of early psychological interventions such as psychological debriefing and single-session psychological intervention on preventing PTSD and PTSSs in children. These results are consistent with a Cochrane review by Rose 2002 of the effects of psychological debriefing for preventing PTSD in adults. However, school-based and family-focused interventions, as well as stepped-procedure and multiple-session psychological interventions have shown promising results.
In conclusion, the current outcomes of the empirical research suggest early interventions that include the following elements31: age-appropriate psychoeducation, the provision of individual coping skills, parental involvement, social support, risk-assessment, multiple sessions and trauma exposure.
The modest results of early psychological interventions suggest a need for a broader perspective on preventive interventions for children and adolescents exposed to nonrelational trauma. Despite the variety of interventions evaluated by the studies included in the two cited reviews none of the studies focused on the practice of health care professionals. This study is the first to conduct a controlled trial of a standardized preventive intervention conducted by health care professionals. The intervention to be evaluated in this study includes all of the above mentioned empirically supported elements except multiple sessions and trauma exposure.
Trauma-informed health care
The concept of trauma-informed practice has been advocated by institutions and researchers in diverse areas such as psychology, mental health care, education, child welfare, first responders, juvenile justice, and health care. The main aim of trauma-informed practice is to create systematic approaches within these areas to develop evidence-based services that address the impact of trauma on the children they serve37. This study will provide evidence on the impact of the practice of HCPs on symptoms, coping and social functioning of children, adolescents and their families who have been exposed to nonrelational trauma. It investigates the effects of educating HCPs in trauma-informed practice and the effects of a standardized trauma-informed plan of action implemented in health care departments working with children and adolescents.
Design of the trial
This study is designed as a controlled trial with one active intervention and one comparison. The study will be conducted across 19 health care departments in 7 hospitals in the Capitol Region of Denmark. There will be two measurement occasions: one assessment 4 weeks after exposure and one follow-up 6 months after exposure. The trial will run over 18 months. During the first 12 months the intervention will run in 12 of the participating departments while the other 8 departments will function as a control group. During the last 6 months the intervention will run in all nineteen departments thus expanding the sample size of the intervention group. Since the intervention is carried out by health care professionals shortly after exposure, the children in the control group will not receive intervention at any point.
Because the intervention investigated in this trial is conducted by HCPs as an integrated part of their general practice (as opposed to a specific treatment program), it was neither practically possible nor ethically sound to design the allocation of participants in the control and intervention group as a randomization of subjects. For this reason, the allocation was done, not on a subject level, but on the level of departments. This precluded an actual randomization of the trial. However, it should be noted that the allocation of the departments is done before the intervention and thus prior to the recruitment of participants. This means that the allocation of subjects was predetermined in advance of their admission to the hospital. This prevents some of the bias associated with the lack of randomization. In the allocation of departments the best possible match of patient groups was pursued.
It is the hypotheses of this study that: The children and adolescents who receive the intervention, compared to participants in the control group, will demonstrate greater reduction in posttraumatic stress, anxiety and depressive symptoms and higher ratings on positive cognitive coping skills and social functioning.
Sample Size and Power Calculation
Given that this is the first trial to examine the effect of a trauma-informed intervention conducted by HCPs as part of their general health care practice, calculations of power were very limited. Furthermore, effect sizes from related trials such as early psychological interventions and interventions based on information provision have been small or non-significant. Given these limitations, however, calculations of power were conducted on the basis of the available evidence.
Results from a study by Kenardy et al. (2008) on an information-provision intervention had an effect size of 0.63 (between groups) on child anxiety. In a similar study by Cox et al. (2010) effect size on child anxiety was 0.33. Based on the results from Cox et al. (2010) a power analysis revealed that 115 families per group (N = 230) will result in 80% power for detecting a significant difference between the intervention and the control group at the 5% significance level. However, with an estimated 25% attrition rate over the assessment time periods, a total of 290 families should be aimed at to be recruited for the study.
Another power analysis was conducted to calculate the power given a specific sample size. This was done because the participating departments are required to include all eligible families presented to the departments during the intervention period. It was estimated that each department would receive two eligible participants per month. Because of the difference in size between the intervention group and the control this resulted in a sample size of 516 for the intervention group and 168 for the control group (N = 684). With an estimated 25 % attrition rate these numbers amount to 387 for the intervention group and 126 for the control group (N = 513). A post hoc power calculation resulted in 94 % power with an effect size of 0.33 and a 5 % significance level.
Statistical Considerations
Prior to statistical analysis of outcomes, the control group and the intervention group will be compared for pre-intervention equivalence on demographic information and type of PTE. If significant differences are identified, this will be taken into account by including these variables as covariates in outcome analyses. The outcome data will be analysed and reported in terms of statistical significance of difference between intervention and control group in change over time on outcome, clinical significance of the change, and effect sizes. The analysis will be performed by researchers who have not been involved in assessing eligibility of participants, collection of data or entering of data.
Primary analysis will be undertaken on an intention-to-treat (ITT) basis, including all participants who have received intervention or have been registered to the control group, regardless of withdrawal from the study. The data will be analysed with a mixed effects model, which is able to include participants whose data may be partly missing. Analysis of covariance will be conducted with three pairs of outcome: 1) child and parent outcome, 2) symptom outcome and coping outcome, and 3) symptom outcome and social functioning outcome. Other outcomes such as demographics and types of PTE will be described.
- Conditions
- Posttraumatic Stress Disorder, Depression, Anxiety
- Being tested
- Preventive intervention trauma-informed early intervention
- Keywords
- prevention, early intervention, trauma-informed practice
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive intervention trauma-informed early interventionOther
Every department appoints 2-4 health care professionals as child welfare officers (CWOs) who will be responsible for carrying out the intervention at the department. Whenever a child or adolescent is present in the department a CWO will be send for. The intervention consists of four distinct elements: 1) A standardized plan of action for the appointed health care CWOs on how to conduct trauma-informed health care for children and their families shortly after exposure to a PTE, 2) a training program for CWOs on trauma-informed support and communication with children and their families, 3) a supervision program for the CWOs, and 4) three psychoeducational booklets for young children, older children, and parents. The booklets will be given to the families by the CWOs.
| Study group | Role | What they receive |
|---|---|---|
| Preventive intervention | Experimental | In this arm HCPs will conduct a trauma-informed early intervention with children and families after exposure to potentially traumatic events (PTE). Receives: Other: Preventive intervention trauma-informed early intervention |
| Control group | No intervention | There will be no intervention in this arm. The outcome will show the efficiency of usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of posttraumatic stress symptoms (Children's Revised Impact of Event Scale.)
The child assessment will be administered with the Children's Revised Impact of Event Scale.
The parent primary outcome measure will be assessed with the Impact of Event Scale.
Measured: 4 weeks after the traumatic event
Severity of posttraumatic stress symptoms (Children's Revised Impact of Event Scale.)
The child assessment will be administered with the Children's Revised Impact of Event Scale.
The parent primary outcome measure will be assessed with the Impact of Event Scale.
Measured: 6 months after the traumatic event
Change from baseline in severity of posttraumatic stress symptoms at 6 months (Children's Revised Impact of Event Scale.)
The child assessment will be administered with the Children's Revised Impact of Event Scale.
The parent primary outcome measure will be assessed with the Impact of Event Scale.
Measured: 4 weeks and 6 months after the traumatic event
Severity of anxiety symptoms (Revised Child Anxiety and Depression Scale.)
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Measured: 4 weeks after the traumatic event
Severity of anxiety symptoms (Revised Child Anxiety and Depression Scale.)
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Measured: 6 months after the traumatic event
Change from baseline in severity of anxiety symptoms at 6 months (Revised Child Anxiety and Depression Scale.)
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Measured: 4 weeks and 6 months after the traumatic event
Severity of depressive symptoms (Revised Child Anxiety and Depression Scale.)
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Measured: 4 weeks after the traumatic event
Severity of depressive symptoms (Revised Child Anxiety and Depression Scale.)
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Measured: 6 months after the traumatic event
Change from baseline in severity of depressive symptoms at 6 months (Revised Child Anxiety and Depression Scale.)
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Measured: 4 weeks and 6 months after the traumatic event
Secondary outcomes (6)
Social functioning of the family (Crisis Support Scale and the WHO-Five Well-being Index.)
The child assessment will be administered with the Crisis Support Scale. The parent secondary outcome measure will be assessed with the Crisis Support Scale and the WHO-Five Well-being Index.
Measured: 4 weeks after the traumatic event
Social functioning of the family (Crisis Support Scale and the WHO-Five Well-being Index.)
The child assessment will be administered with the Crisis Support Scale. The parent secondary outcome measure will be assessed with the Crisis Support Scale and the WHO-Five Well-being Index.
Measured: 6 months after the traumatic event
Change from baseline in social functioning of the family at 6 months (Crisis Support Scale and the WHO-Five Well-being Index.)
The child assessment will be administered with the Crisis Support Scale. The parent secondary outcome measure will be assessed with the Crisis Support Scale and the WHO-Five Well-being Index.
Measured: 4 weeks and 6 months after the traumatic event
Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.)
The child assessment will be administered with the Children's Post-traumatic Cognitions Inventory.
The parent secondary outcome measure will be assessed with the Post-traumatic Cognitions Inventory.
Measured: 4 weeks after the traumatic event
Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.)
The child assessment will be administered with the Children's Post-traumatic Cognitions Inventory.
The parent secondary outcome measure will be assessed with the Post-traumatic Cognitions Inventory.
Measured: 6 months after the traumatic event
Change from baseline in cognitive coping skills of the children and their parents at 6 months ( Post-traumatic Cognitions Inventory.)
The child assessment will be administered with the Children's Post-traumatic Cognitions Inventory.
The parent secondary outcome measure will be assessed with the Post-traumatic Cognitions Inventory.
Measured: 4 weeks and 6 months after the traumatic event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 684 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carolina Magdalene Maier
- Sponsor type
- University, hospital or other
- Collaborators
- The Egmont Foundation, Ramboll Group
- Responsible party
- Sponsor-investigator, Carolina Magdalene Maier, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lasse P Michelsen, MA, Principal investigator, Copenhagen University Hospital, RigshospitaletDitte B Eriksen, LPsy, Principal investigator, Copenhagen University Hospital, RigshospitaletCarolina M Maier, MSc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299583
- Sponsor's protocol ID
- f-22834-02
- Status last verified
- Nov 2014
- First submitted
- 14 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Costello EJ, Erkanli A, Fairbank JA, Angold A. The prevalence of potentially traumatic events in childhood and adolescence. J Trauma Stress. 2002 Apr;15(2):99-112. doi: 10.1023/A:1014851823163.
PubMed 12013070Cox CM, Kenardy JA, Hendrikz JK. A randomized controlled trial of a web-based early intervention for children and their parents following unintentional injury. J Pediatr Psychol. 2010 Jul;35(6):581-92. doi: 10.1093/jpepsy/jsp095. Epub 2009 Nov 11.
PubMed 19906829Elklit A, Petersen T. Exposure to traumatic events among adolescents in four nations. Torture. 2008;18(1):2-11.
PubMed 19289877Hamilton BE, Hoyert DL, Martin JA, Strobino DM, Guyer B. Annual summary of vital statistics: 2010-2011. Pediatrics. 2013 Mar;131(3):548-58. doi: 10.1542/peds.2012-3769. Epub 2013 Feb 11.
PubMed 23400611Di Gallo A, Barton J, Parry-Jones WL. Road traffic accidents: early psychological consequences in children and adolescents. Br J Psychiatry. 1997 Apr;170:358-62. doi: 10.1192/bjp.170.4.358.
PubMed 9246255Mirza KA, Bhadrinath BR, Goodyer IM, Gilmour C. Post-traumatic stress disorder in children and adolescents following road traffic accidents. Br J Psychiatry. 1998 May;172:443-7. doi: 10.1192/bjp.172.5.443.
PubMed 9747409Stallard P, Velleman R, Baldwin S. Prospective study of post-traumatic stress disorder in children involved in road traffic accidents. BMJ. 1998 Dec 12;317(7173):1619-23. doi: 10.1136/bmj.317.7173.1619.
PubMed 9848900Stallard P, Velleman R, Baldwin S. Psychological screening of children for post-traumatic stress disorder. J Child Psychol Psychiatry. 1999 Oct;40(7):1075-82.
PubMed 10576537de Vries AP, Kassam-Adams N, Cnaan A, Sherman-Slate E, Gallagher PR, Winston FK. Looking beyond the physical injury: posttraumatic stress disorder in children and parents after pediatric traffic injury. Pediatrics. 1999 Dec;104(6):1293-9. doi: 10.1542/peds.104.6.1293.
PubMed 10585980McDermott BM, Cvitanovich A. Posttraumatic stress disorder and emotional problems in children following motor vehicle accidents: an extended case series. Aust N Z J Psychiatry. 2000 Jun;34(3):446-52. doi: 10.1080/j.1440-1614.2000.00753.x.
PubMed 10881968Keppel-Benson JM, Ollendick TH, Benson MJ. Post-traumatic stress in children following motor vehicle accidents. J Child Psychol Psychiatry. 2002 Feb;43(2):203-12. doi: 10.1111/1469-7610.00013.
PubMed 11902599Landolt MA, Vollrath M, Timm K, Gnehm HE, Sennhauser FH. Predicting posttraumatic stress symptoms in children after road traffic accidents. J Am Acad Child Adolesc Psychiatry. 2005 Dec;44(12):1276-83. doi: 10.1097/01.chi.0000181045.13960.67.
PubMed 16292120Kassam-Adams N, Winston FK. Predicting child PTSD: the relationship between acute stress disorder and PTSD in injured children. J Am Acad Child Adolesc Psychiatry. 2004 Apr;43(4):403-11. doi: 10.1097/00004583-200404000-00006.
PubMed 15187800Carrion VG, Weems CF, Ray R, Reiss AL. Toward an empirical definition of pediatric PTSD: the phenomenology of PTSD symptoms in youth. J Am Acad Child Adolesc Psychiatry. 2002 Feb;41(2):166-73. doi: 10.1097/00004583-200202000-00010.
PubMed 11837406Scheeringa MS, Zeanah CH, Myers L, Putnam FW. New findings on alternative criteria for PTSD in preschool children. J Am Acad Child Adolesc Psychiatry. 2003 May;42(5):561-70. doi: 10.1097/01.CHI.0000046822.95464.14.
PubMed 12707560
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Controlled Trial of Early Intervention With Children and Adolescents Exposed to Nonrelational Traumatic Events Comparing Trauma-informed and Usual Health Care Practice
- ClinicalTrials.gov ID
- NCT02299583
- Acronym / sponsor ID
- f-22834-02
- Conditions
- Posttraumatic Stress Disorder, Depression, Anxiety
- Keywords
- prevention, early intervention, trauma-informed practice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 684 participants (estimated)
- Lead sponsor
- Carolina Magdalene MaierUniversity, hospital or other
- Collaborators
- The Egmont Foundation, Ramboll Group
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: International studies have shown that a substantial number of children and adolescents are exposed to potentially traumatic events. Many of these children and adolescents, some of whom will experience posttraumatic stress disorder (PTSD), are submitted to health care departments shortly after exposure as the most common types of traumatic events are accidental injury, serious somatic illness or death of someone close. There has been some research on early psychological interventions for prevention and treatment of PTSD. However, very little research has examined the efficacy of trauma-informed practice among health care professionals (HCPs). The present trial aims to evaluate and compare trauma-informed health care with usual practice.
Methods/Design: The primary clinical question under investigation is the efficacy of an early, trauma-informed intervention for the prevention of PTSD in children and adolescents following exposure to a potentially traumatic event. The trail compares a standardized trauma-informed practice with usual care (no intervention) in health care departments receiving children and adolescents after exposure to determine if trauma-informed care is associated with a reduction in psychological outcome measures over time. Specifically, the investigators examine the efficacy of health care professional's active use of trauma-informed standards of action and a trauma training program for HCPs in the intervention group. The primary outcome will be a reduction in trauma, anxiety and depressive symptoms on self-reports in the active intervention compared to usual care.
Discussion: This trial will be the first controlled trial to examine a trauma-informed intervention carried out by HCPs. It will provide the first evidence on the efficacy of health care delivered by trauma-educated HCPs using trauma-informed standards of action. A successful implementation of this protocol will support the thesis that prevention of PTSD among children and adolescents benefits from a focus on the practice of HCPs. If efficacious, the results will be a call for future research to extend the investigation of interventions from psychological treatment to HCP-based care.
Detailed description
Background
A significant number of children and adolescents have been exposed to potentially traumatic events (PTEs). American and Australian studies report a prevalence of about 20-25% of high magnitude traumatic events among adolescents. A Danish study of four Nordic countries found that 90 % of adolescents with a mean age of 14.5 years had been exposed to at least one low magnitude traumatic event.
A potentially traumatic event may be either relational such as sexual or physical abuse or nonrelational such as illness, motor vehicle accident or fire. The incidence of nonrelational trauma is very high in children and adolescents with accidental injuries being the largest cause of morbidity and mortality among children in the United States as well as in Denmark. Although many children and adolescents demonstrate great resilience or appear to be only briefly affected by nonrelational traumatic events a significant minority of young people will develop posttraumatic stress disorder (PTSD), posttraumatic stress symptoms (PTSSs) or other psychological difficulties following exposure to trauma.
Accidental injury is the most common type of trauma. Researchers report prevalence rates of PTSD among children and adolescents in road traffic accidents ranging from 6% to 35%. Rates of PTSSs (also termed subclinical, subthreshold or partial PTSD) range from 11% to 50%6-14. These rates are important since recent research has indicated only minor differences in terms of distress and impairment between children meeting full and partial criteria for PTSD.
The diagnosis of medical illness such as cancer or diabetes has also been shown to cause PTSD in some children and adolescents with prevalence rates of 5.4% for diabetes and of 10% to 18% for cancer. A recent meta-analysis of prevalence related to both injury and illness reported average prevalence rates of PTSD related to injury ranging from 0% to 37.5%, with a mean of 19.82%, and rates in ill youth ranging from 0% to 32%, with a mean of 12.04%.
Preventive interventions for children and adolescents
Given the high prevalence rates of exposure and the likewise high prevalence rates of PTSD and PTSSs after PTEs there is a pressing need for preventive interventions that decrease the risk of PTSD. In a recent systematic review by Forman-Hoffman et al. (2013) of interventions for children exposed to nonrelational traumatic events 6 different interventions based exclusively on exposure were identified. These included trauma-focused cognitive-behavioural therapy child and family traumatic stress intervention (CFTSI), 2 different school interventions with elements of CBT, early psychological intervention and a propranolol study. The two latter studies found no improvement in outcomes, the remaining 4 interventions found some improvement with regards to PTSD, severity of PTSD and PTSSs.
Another recent meta-analysis by Kramer (2011) reviewing early psychological interventions in children and adolescents after single trauma included seven studies (two of which reappeared in the above mentioned review). These included CFTSI, school-based interventions, early psychological interventions, and two interventions based exclusively on psychoeducational information provision. The authors concluded that intervention effects regarding PTSSs and PTSD were small or non-significant but found promising beneficial tendencies with regards to dissociation, anxiety and, to some extent, arousal.
Overall, the empirical literature has not supported the effectiveness of early psychological interventions such as psychological debriefing and single-session psychological intervention on preventing PTSD and PTSSs in children. These results are consistent with a Cochrane review by Rose 2002 of the effects of psychological debriefing for preventing PTSD in adults. However, school-based and family-focused interventions, as well as stepped-procedure and multiple-session psychological interventions have shown promising results.
In conclusion, the current outcomes of the empirical research suggest early interventions that include the following elements31: age-appropriate psychoeducation, the provision of individual coping skills, parental involvement, social support, risk-assessment, multiple sessions and trauma exposure.
The modest results of early psychological interventions suggest a need for a broader perspective on preventive interventions for children and adolescents exposed to nonrelational trauma. Despite the variety of interventions evaluated by the studies included in the two cited reviews none of the studies focused on the practice of health care professionals. This study is the first to conduct a controlled trial of a standardized preventive intervention conducted by health care professionals. The intervention to be evaluated in this study includes all of the above mentioned empirically supported elements except multiple sessions and trauma exposure.
Trauma-informed health care
The concept of trauma-informed practice has been advocated by institutions and researchers in diverse areas such as psychology, mental health care, education, child welfare, first responders, juvenile justice, and health care. The main aim of trauma-informed practice is to create systematic approaches within these areas to develop evidence-based services that address the impact of trauma on the children they serve37. This study will provide evidence on the impact of the practice of HCPs on symptoms, coping and social functioning of children, adolescents and their families who have been exposed to nonrelational trauma. It investigates the effects of educating HCPs in trauma-informed practice and the effects of a standardized trauma-informed plan of action implemented in health care departments working with children and adolescents.
Design of the trial
This study is designed as a controlled trial with one active intervention and one comparison. The study will be conducted across 19 health care departments in 7 hospitals in the Capitol Region of Denmark. There will be two measurement occasions: one assessment 4 weeks after exposure and one follow-up 6 months after exposure. The trial will run over 18 months. During the first 12 months the intervention will run in 12 of the participating departments while the other 8 departments will function as a control group. During the last 6 months the intervention will run in all nineteen departments thus expanding the sample size of the intervention group. Since the intervention is carried out by health care professionals shortly after exposure, the children in the control group will not receive intervention at any point.
Because the intervention investigated in this trial is conducted by HCPs as an integrated part of their general practice (as opposed to a specific treatment program), it was neither practically possible nor ethically sound to design the allocation of participants in the control and intervention group as a randomization of subjects. For this reason, the allocation was done, not on a subject level, but on the level of departments. This precluded an actual randomization of the trial. However, it should be noted that the allocation of the departments is done before the intervention and thus prior to the recruitment of participants. This means that the allocation of subjects was predetermined in advance of their admission to the hospital. This prevents some of the bias associated with the lack of randomization. In the allocation of departments the best possible match of patient groups was pursued.
It is the hypotheses of this study that: The children and adolescents who receive the intervention, compared to participants in the control group, will demonstrate greater reduction in posttraumatic stress, anxiety and depressive symptoms and higher ratings on positive cognitive coping skills and social functioning.
Sample Size and Power Calculation
Given that this is the first trial to examine the effect of a trauma-informed intervention conducted by HCPs as part of their general health care practice, calculations of power were very limited. Furthermore, effect sizes from related trials such as early psychological interventions and interventions based on information provision have been small or non-significant. Given these limitations, however, calculations of power were conducted on the basis of the available evidence.
Results from a study by Kenardy et al. (2008) on an information-provision intervention had an effect size of 0.63 (between groups) on child anxiety. In a similar study by Cox et al. (2010) effect size on child anxiety was 0.33. Based on the results from Cox et al. (2010) a power analysis revealed that 115 families per group (N = 230) will result in 80% power for detecting a significant difference between the intervention and the control group at the 5% significance level. However, with an estimated 25% attrition rate over the assessment time periods, a total of 290 families should be aimed at to be recruited for the study.
Another power analysis was conducted to calculate the power given a specific sample size. This was done because the participating departments are required to include all eligible families presented to the departments during the intervention period. It was estimated that each department would receive two eligible participants per month. Because of the difference in size between the intervention group and the control this resulted in a sample size of 516 for the intervention group and 168 for the control group (N = 684). With an estimated 25 % attrition rate these numbers amount to 387 for the intervention group and 126 for the control group (N = 513). A post hoc power calculation resulted in 94 % power with an effect size of 0.33 and a 5 % significance level.
Statistical Considerations
Prior to statistical analysis of outcomes, the control group and the intervention group will be compared for pre-intervention equivalence on demographic information and type of PTE. If significant differences are identified, this will be taken into account by including these variables as covariates in outcome analyses. The outcome data will be analysed and reported in terms of statistical significance of difference between intervention and control group in change over time on outcome, clinical significance of the change, and effect sizes. The analysis will be performed by researchers who have not been involved in assessing eligibility of participants, collection of data or entering of data.
Primary analysis will be undertaken on an intention-to-treat (ITT) basis, including all participants who have received intervention or have been registered to the control group, regardless of withdrawal from the study. The data will be analysed with a mixed effects model, which is able to include participants whose data may be partly missing. Analysis of covariance will be conducted with three pairs of outcome: 1) child and parent outcome, 2) symptom outcome and coping outcome, and 3) symptom outcome and social functioning outcome. Other outcomes such as demographics and types of PTE will be described.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventive intervention | Experimental | Other: Preventive intervention trauma-informed early interventionIn this arm HCPs will conduct a trauma-informed early intervention with children and families after exposure to potentially traumatic events (PTE). |
| Control group | No intervention | –There will be no intervention in this arm. The outcome will show the efficiency of usual care. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Aged between 8 and 18 years
- Admission to hospital for accidental injury involving danger to life, serious injury or impairment
- Admission to hospital for acute illness involving danger to life, serious injury or impairment
- Sudden severe impairment of medical condition
- Admission of parent or sibling to hospital for accidental injury involving danger to life, serious injury or impairment
Key exclusion criteria (4 listed)
- Parent's Danish insufficient for questionnaire completion
- Developmental delay or mental retardation in the child
- Moderate to severe head injury or posttraumatic amnesia following the accident
- Injury due to physical or sexual abuse (intentional injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive intervention trauma-informed early interventionEvery department appoints 2-4 health care professionals as child welfare officers (CWOs) who will be responsible for carrying out the intervention at the department. Whenever a child or adolescent is present in the department a CWO will be send for. The intervention consists of four distinct elements: 1) A standardized plan of action for the appointed health care CWOs on how to conduct trauma-informed health care for children and their families shortly after exposure to a PTE, 2) a training program for CWOs on trauma-informed support and communication with children and their families, 3) a supervision program for the CWOs, and 4) three psychoeducational booklets for young children, older children, and parents. The booklets will be given to the families by the CWOs. | Other | Preventive intervention |
Primary outcome
Severity of posttraumatic stress symptoms (Children's Revised Impact of Event Scale.)
Time frame: 4 weeks after the traumatic event
The child assessment will be administered with the Children's Revised Impact of Event Scale. The parent primary outcome measure will be assessed with the Impact of Event Scale.
Severity of posttraumatic stress symptoms (Children's Revised Impact of Event Scale.)
Time frame: 6 months after the traumatic event
The child assessment will be administered with the Children's Revised Impact of Event Scale. The parent primary outcome measure will be assessed with the Impact of Event Scale.
Change from baseline in severity of posttraumatic stress symptoms at 6 months (Children's Revised Impact of Event Scale.)
Time frame: 4 weeks and 6 months after the traumatic event
The child assessment will be administered with the Children's Revised Impact of Event Scale. The parent primary outcome measure will be assessed with the Impact of Event Scale.
Severity of anxiety symptoms (Revised Child Anxiety and Depression Scale.)
Time frame: 4 weeks after the traumatic event
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Severity of anxiety symptoms (Revised Child Anxiety and Depression Scale.)
Time frame: 6 months after the traumatic event
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Change from baseline in severity of anxiety symptoms at 6 months (Revised Child Anxiety and Depression Scale.)
Time frame: 4 weeks and 6 months after the traumatic event
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Severity of depressive symptoms (Revised Child Anxiety and Depression Scale.)
Time frame: 4 weeks after the traumatic event
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Severity of depressive symptoms (Revised Child Anxiety and Depression Scale.)
Time frame: 6 months after the traumatic event
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
Change from baseline in severity of depressive symptoms at 6 months (Revised Child Anxiety and Depression Scale.)
Time frame: 4 weeks and 6 months after the traumatic event
The assessment will be administered with the Revised Child Anxiety and Depression Scale.
6 secondary outcomes
Social functioning of the family (Crisis Support Scale and the WHO-Five Well-being Index.)
Time frame: 4 weeks after the traumatic event
Social functioning of the family (Crisis Support Scale and the WHO-Five Well-being Index.)
Time frame: 6 months after the traumatic event
Change from baseline in social functioning of the family at 6 months (Crisis Support Scale and the WHO-Five Well-being Index.)
Time frame: 4 weeks and 6 months after the traumatic event
Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.)
Time frame: 4 weeks after the traumatic event
Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.)
Time frame: 6 months after the traumatic event
Change from baseline in cognitive coping skills of the children and their parents at 6 months ( Post-traumatic Cognitions Inventory.)
Time frame: 4 weeks and 6 months after the traumatic event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Background: PubMed 12013070Costello EJ, Erkanli A, Fairbank JA, Angold A. The prevalence of potentially traumatic events in childhood and adolescence. J Trauma Stress. 2002 Apr;15(2):99-112. doi: 10.1023/A:1014851823163.
- Background: PubMed 19906829Cox CM, Kenardy JA, Hendrikz JK. A randomized controlled trial of a web-based early intervention for children and their parents following unintentional injury. J Pediatr Psychol. 2010 Jul;35(6):581-92. doi: 10.1093/jpepsy/jsp095. Epub 2009 Nov 11.
- Background: PubMed 19289877Elklit A, Petersen T. Exposure to traumatic events among adolescents in four nations. Torture. 2008;18(1):2-11.
- Background: PubMed 23400611Hamilton BE, Hoyert DL, Martin JA, Strobino DM, Guyer B. Annual summary of vital statistics: 2010-2011. Pediatrics. 2013 Mar;131(3):548-58. doi: 10.1542/peds.2012-3769. Epub 2013 Feb 11.
- Background: PubMed 9246255Di Gallo A, Barton J, Parry-Jones WL. Road traffic accidents: early psychological consequences in children and adolescents. Br J Psychiatry. 1997 Apr;170:358-62. doi: 10.1192/bjp.170.4.358.
- Background: PubMed 9747409Mirza KA, Bhadrinath BR, Goodyer IM, Gilmour C. Post-traumatic stress disorder in children and adolescents following road traffic accidents. Br J Psychiatry. 1998 May;172:443-7. doi: 10.1192/bjp.172.5.443.
- Background: PubMed 9848900Stallard P, Velleman R, Baldwin S. Prospective study of post-traumatic stress disorder in children involved in road traffic accidents. BMJ. 1998 Dec 12;317(7173):1619-23. doi: 10.1136/bmj.317.7173.1619.
- Background: PubMed 10576537Stallard P, Velleman R, Baldwin S. Psychological screening of children for post-traumatic stress disorder. J Child Psychol Psychiatry. 1999 Oct;40(7):1075-82.
- Background: PubMed 10585980de Vries AP, Kassam-Adams N, Cnaan A, Sherman-Slate E, Gallagher PR, Winston FK. Looking beyond the physical injury: posttraumatic stress disorder in children and parents after pediatric traffic injury. Pediatrics. 1999 Dec;104(6):1293-9. doi: 10.1542/peds.104.6.1293.
- Background: PubMed 10881968McDermott BM, Cvitanovich A. Posttraumatic stress disorder and emotional problems in children following motor vehicle accidents: an extended case series. Aust N Z J Psychiatry. 2000 Jun;34(3):446-52. doi: 10.1080/j.1440-1614.2000.00753.x.
- Background: PubMed 11902599Keppel-Benson JM, Ollendick TH, Benson MJ. Post-traumatic stress in children following motor vehicle accidents. J Child Psychol Psychiatry. 2002 Feb;43(2):203-12. doi: 10.1111/1469-7610.00013.
- Background: PubMed 16292120Landolt MA, Vollrath M, Timm K, Gnehm HE, Sennhauser FH. Predicting posttraumatic stress symptoms in children after road traffic accidents. J Am Acad Child Adolesc Psychiatry. 2005 Dec;44(12):1276-83. doi: 10.1097/01.chi.0000181045.13960.67.
Related trials for Posttraumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina M Maier, MSc contact
Lasse P Michelsen, MA principal investigator
Copenhagen University Hospital, Rigshospitalet
Ditte B Eriksen, LPsy principal investigator
Copenhagen University Hospital, Rigshospitalet
Carolina M Maier, MSc study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive intervention trauma-informed early intervention in people with Posttraumatic Stress Disorder and Depression, run by Carolina Magdalene Maier at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina M Maier, MSc (carolina.magdalene.maier@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of posttraumatic stress symptoms (Children's Revised Impact of Event Scale.) (time frame: 4 weeks after the traumatic event). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299583, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.