Prevention of Posttraumatic Stress Symptoms in Young Children With Burns: a Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Psychological Interventions in Children After Road Traffic Accidents or Burns

NCT01085370

Acute Stress Disorder

COMPLETED NA

Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial

NCT00296842

Injury

COMPLETED NA

Dysfunctional Posttraumatic Cognitions in Children and Adolescents

NCT02693249

Motor Vehicle Accident Burns

COMPLETED

Reducing PTSD in Hospitalized Burn Patients

NCT02026037

Posttraumatic Stress Disorder

COMPLETED NA

Evaluating Effectiveness of Dyadic Prolonged Exposure on 2-4 Years Old vs. Toddler-parent Focused Treatment

NCT02226393

Post-Traumatic Stress Disorder in Children

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Burns

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

'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

Group Type EXPERIMENTAL

'EPICAP'

Intervention Type BEHAVIORAL

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

Medical treatment as usual

Medical treatment of burn injuries as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

'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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ages 1- 4 years
* Acute burn injury
* Treatment at University Children's Hospital Zurich

Exclusion Criteria

* 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

Minimum Eligible Age

1 Year

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No