BurnsEPICAPNCT02088814
Prevention of Posttraumatic Stress Symptoms in Young Children With Burns: a Randomized Controlled Trial
A study testing 'EPICAP' in people with Burns, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
Background: Previous studies have found considerable rates of posttraumatic stress disorder (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with injuries following accidental trauma. Read more about this study
- Who is it for?
- Ages 1 year to 4 years
- Conditions the study is for
- Burns
- What is being tested?
- 'EPICAP'
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Dec 2017
- 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 1 year to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 1- 4 years
- Acute burn injury
- Treatment at University Children's Hospital Zurich
Who cannot join
- severe comorbid head injury in the child (Glasgow Coma Scale < 9)
- expected initial stay in the pediatric intensive care unit for more than a week
- burn injury due to suspected or substantiated child abuse
- any previous evidence of cognitive impairment or pervasive developmental disorder in the child
- insufficient command of the German language in both parents
Trial locations and contacts
1 site in 1 country.
About this study
Background: Previous studies have found considerable rates of posttraumatic stress disorder (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with injuries following accidental trauma. In consequence, secondary preventive efforts (early interventions) should be undertaken to minimize such long-term deleterious consequences in children.
Aims: The proposed study aims at examining the effect of a newly developed, standardized early psychological intervention in reducing posttraumatic maladjustment and in enhancing health-related quality of life in children ages 1 to 4 years with acute burn injuries.
Method: The study is designed as a randomized controlled trial within a stepped procedure. First, eligible children will be screened 5 to 7 days post injury by means of a standardized measure for their risk of developing PTSS. After a baseline assessment, children at risk will then be randomly allocated to either a control group (standard medical care) or an intervention group. Participants of the intervention group will be provided with the standardized "EPICAP 1-4" intervention which uses established cognitive-behavioral techniques and is directed to the parents. The intervention consists of two face-to-face sessions (at baseline and 1 week later) and a follow-up call or short follow-up face-to-face meeting (6 weeks after the first session). Blinded follow- up assessments with standardized parent report measures will be conducted at 3 and 6 months post injury. The primary outcome measures are child PTSD and PTSS, secondary outcome measures include child behavior and health-related quality of life. In addition, a variety of socio-demographic, medical and parental variables will be assessed as co-variates. Children screened as low-risk will be reassessed only at 6 months to make sure that the screening procedure is valid.
Read the detailed description
Background: Unintentional injuries in preschoolers are frequent. Many accidents meet criteria for a psychotraumatic event as defined by the DSM-IV. It is therefore not surprising that previous studies have found considerable rates of posttraumatic stress disorder (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with injuries following accidental trauma, such as road traffic or burn accidents. In consequence, secondary preventive efforts (early interventions) should be undertaken to minimize such long-term deleterious consequences in children. While important components of successful early interventions have been identified in school-age children, evidence is completely lacking for younger children, especially for those below the age of 4 years.
Aims: The proposed study aims at examining the effect of a newly developed, standardized early psychological intervention in reducing posttraumatic maladjustment and in enhancing health-related quality of life in children ages 1 to 4 years with acute burn injuries. Also, the effectiveness of an early screening measure in identyfing children with high risk for psychological follow-up problems shall be studied.
Method: The study is designed as a randomized controlled trial within a stepped procedure. First, eligible children will be screened 5 to 7 days post injury by means of a standardized measure for their risk of developing PTSS. After a baseline assessment, children at risk will then be randomly allocated to either a control group (standard medical care) or an intervention group. Participants of the intervention group will be provided with the standardized "EPICAP 1-4" intervention which uses established cognitive-behavioral techniques and is directed to the parents. The intervention includes the following components: psychoeducation on child and parental PTSS, promotion of adaptive strategies to manage child and parental distress, construction of a parental trauma narrative, promotion of strategies that increase parental capacity and enhance parent-child relationship. The intervention consists of two face-to-face sessions with the parents (at baseline and 1 week later) and a follow-up call or short follow-up face-to-face meeting (6 weeks after the first session). Blinded follow- up assessments with standardized parent report measures will be conducted at 3 and 6 months post injury. The primary outcome measures are child PTSD and PTSS, secondary outcome measures include child behavior and health-related quality of life. In addition, a variety of socio-demographic, medical and parental variables will be assessed as co-variates. Children screened as low-risk will be reassessed only at 6 months to make sure that the screening procedure is valid.
- Conditions
- Burns
- Being tested
- 'EPICAP'
- Keywords
- posttraumatic stress, burns, injuries, children
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'EPICAP'Behavioural
standardized, secondary preventive psychological intervention with parents of children ages 1-4 with acute burn injuries, consisting of psychoeducation, trauma narrative, storybook, provision of coping skills
| Study group | Role | What they receive |
|---|---|---|
| 'EPICAP' | Experimental | Secondary preventive psychological intervention with parents of children ages 1-4 with acute burn injuries, consisting of psychoeducation, trauma narrative, storybook, provision of coping skills Receives: Behavioral: 'EPICAP' |
| Medical treatment as usual | No intervention | Medical treatment of burn injuries as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
DIPA PTSD Module
The DIPA PTSD module is an interview of caregivers for children from nine months to six years old that assesses DSM-5 PTSD preschool criteria.
Measured: 6 months
Secondary outcomes (2)
Child Behavior Checklist 11⁄2-5 (CBCL; Achenbach & Rescorla, 2000)
This is a highly standardized, widely used and well validated 100-item parent-report measure for children ages 1.5 to 5 years.3 Caregivers have to report the extent to which they agree with statements on a 3-point Likert scale ranging from 1 (not true) to 3 (very true). The questionnaire yields scores for two broad-band sca- les (internalizing and externalizing behavior problems), and an overall total behavioral problems score.
Measured: 6 months
TNO-AZL Preschool Children Quality of Life Questionnaire (TAPQOL; Fekkes et al., 2000).
The TAPQOL is a 43-item multidimensional instrument that yields sum scores for physical, emotional, social, and cognitive functioning by parent report. Also, an overall sum score indicating general HRQoL can be computed. The TAPQOL can be applied to children of 9 months to 6 years of age. It has good construct, criterion, and concurrent validity and a good internal consistency.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus A. Landolt, University Children's Hospital, Zurich
- Investigators
- Markus A. Landolt, PhD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088814
- Sponsor's protocol ID
- 100014_149158
- Acronym
- EPICAP
- Status last verified
- Apr 2019
- First submitted
- 12 Mar 2014
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Haag AC, Landolt MA. Young Children's Acute Stress After a Burn Injury: Disentangling the Role of Injury Severity and Parental Acute Stress. J Pediatr Psychol. 2017 Sep 1;42(8):861-870. doi: 10.1093/jpepsy/jsx059.
PubMed 28340168De Young AC, Haag AC, Kenardy JA, Kimble RM, Landolt MA. Coping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: study protocol for two randomised controlled trials. Trials. 2016 Jul 28;17:362. doi: 10.1186/s13063-016-1490-2.
PubMed 27464735Haag AC, Landolt MA, Kenardy JA, Schiestl CM, Kimble RM, De Young AC. Preventive intervention for trauma reactions in young injured children: results of a multi-site randomised controlled trial. J Child Psychol Psychiatry. 2020 Sep;61(9):988-997. doi: 10.1111/jcpp.13193. Epub 2020 Jan 8.
PubMed 31912485
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Posttraumatic Stress Symptoms in Young Children With Burns: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02088814
- Acronym / sponsor ID
- EPICAP / 100014_149158
- Conditions
- Burns
- Keywords
- posttraumatic stress, burns, injuries, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Mar 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: Previous studies have found considerable rates of posttraumatic stress disorder (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with injuries following accidental trauma. In consequence, secondary preventive efforts (early interventions) should be undertaken to minimize such long-term deleterious consequences in children.
Aims: The proposed study aims at examining the effect of a newly developed, standardized early psychological intervention in reducing posttraumatic maladjustment and in enhancing health-related quality of life in children ages 1 to 4 years with acute burn injuries.
Method: The study is designed as a randomized controlled trial within a stepped procedure. First, eligible children will be screened 5 to 7 days post injury by means of a standardized measure for their risk of developing PTSS. After a baseline assessment, children at risk will then be randomly allocated to either a control group (standard medical care) or an intervention group. Participants of the intervention group will be provided with the standardized "EPICAP 1-4" intervention which uses established cognitive-behavioral techniques and is directed to the parents. The intervention consists of two face-to-face sessions (at baseline and 1 week later) and a follow-up call or short follow-up face-to-face meeting (6 weeks after the first session). Blinded follow- up assessments with standardized parent report measures will be conducted at 3 and 6 months post injury. The primary outcome measures are child PTSD and PTSS, secondary outcome measures include child behavior and health-related quality of life. In addition, a variety of socio-demographic, medical and parental variables will be assessed as co-variates. Children screened as low-risk will be reassessed only at 6 months to make sure that the screening procedure is valid.
Detailed description
Background: Unintentional injuries in preschoolers are frequent. Many accidents meet criteria for a psychotraumatic event as defined by the DSM-IV. It is therefore not surprising that previous studies have found considerable rates of posttraumatic stress disorder (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with injuries following accidental trauma, such as road traffic or burn accidents. In consequence, secondary preventive efforts (early interventions) should be undertaken to minimize such long-term deleterious consequences in children. While important components of successful early interventions have been identified in school-age children, evidence is completely lacking for younger children, especially for those below the age of 4 years.
Aims: The proposed study aims at examining the effect of a newly developed, standardized early psychological intervention in reducing posttraumatic maladjustment and in enhancing health-related quality of life in children ages 1 to 4 years with acute burn injuries. Also, the effectiveness of an early screening measure in identyfing children with high risk for psychological follow-up problems shall be studied.
Method: The study is designed as a randomized controlled trial within a stepped procedure. First, eligible children will be screened 5 to 7 days post injury by means of a standardized measure for their risk of developing PTSS. After a baseline assessment, children at risk will then be randomly allocated to either a control group (standard medical care) or an intervention group. Participants of the intervention group will be provided with the standardized "EPICAP 1-4" intervention which uses established cognitive-behavioral techniques and is directed to the parents. The intervention includes the following components: psychoeducation on child and parental PTSS, promotion of adaptive strategies to manage child and parental distress, construction of a parental trauma narrative, promotion of strategies that increase parental capacity and enhance parent-child relationship. The intervention consists of two face-to-face sessions with the parents (at baseline and 1 week later) and a follow-up call or short follow-up face-to-face meeting (6 weeks after the first session). Blinded follow- up assessments with standardized parent report measures will be conducted at 3 and 6 months post injury. The primary outcome measures are child PTSD and PTSS, secondary outcome measures include child behavior and health-related quality of life. In addition, a variety of socio-demographic, medical and parental variables will be assessed as co-variates. Children screened as low-risk will be reassessed only at 6 months to make sure that the screening procedure is valid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'EPICAP' | Experimental | Behavioral: 'EPICAP'Secondary preventive psychological intervention with parents of children ages 1-4 with acute burn injuries, consisting of psychoeducation, trauma narrative, storybook, provision of coping skills |
| Medical treatment as usual | No intervention | –Medical treatment of burn injuries as usual |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 1- 4 years
- Acute burn injury
- Treatment at University Children's Hospital Zurich
Key exclusion criteria (5 listed)
- severe comorbid head injury in the child (Glasgow Coma Scale < 9)
- expected initial stay in the pediatric intensive care unit for more than a week
- burn injury due to suspected or substantiated child abuse
- any previous evidence of cognitive impairment or pervasive developmental disorder in the child
- insufficient command of the German language in both parents
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 |
|---|---|---|
| 'EPICAP'standardized, secondary preventive psychological intervention with parents of children ages 1-4 with acute burn injuries, consisting of psychoeducation, trauma narrative, storybook, provision of coping skills | Behavioural | 'EPICAP' |
Primary outcome
DIPA PTSD Module
Time frame: 6 months
The DIPA PTSD module is an interview of caregivers for children from nine months to six years old that assesses DSM-5 PTSD preschool criteria.
2 secondary outcomes
Child Behavior Checklist 11⁄2-5 (CBCL; Achenbach & Rescorla, 2000)
Time frame: 6 months
TNO-AZL Preschool Children Quality of Life Questionnaire (TAPQOL; Fekkes et al., 2000).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Background: PubMed 28340168Haag AC, Landolt MA. Young Children's Acute Stress After a Burn Injury: Disentangling the Role of Injury Severity and Parental Acute Stress. J Pediatr Psychol. 2017 Sep 1;42(8):861-870. doi: 10.1093/jpepsy/jsx059.
- Background: PubMed 27464735De Young AC, Haag AC, Kenardy JA, Kimble RM, Landolt MA. Coping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: study protocol for two randomised controlled trials. Trials. 2016 Jul 28;17:362. doi: 10.1186/s13063-016-1490-2.
- Derived from this study: PubMed 31912485Haag AC, Landolt MA, Kenardy JA, Schiestl CM, Kimble RM, De Young AC. Preventive intervention for trauma reactions in young injured children: results of a multi-site randomised controlled trial. J Child Psychol Psychiatry. 2020 Sep;61(9):988-997. doi: 10.1111/jcpp.13193. Epub 2020 Jan 8.
- Individual participant dataSharing planned: No
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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.
Markus A. Landolt, PhD principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'EPICAP' in people with Burns, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 Apr 2019. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIPA PTSD Module (time frame: 6 months). 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 NCT02088814, which also lists 3 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 22 Apr 2019.