Prevention of Posttraumatic Stress Symptoms in Young Children With Burns: a Randomized Controlled Trial
Condition: Burns
MeSH terms: Burns
Study type: Interventional

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. 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.
    

Intervention name(s): 'EPICAP'
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: posttraumatic stress; burns; injuries; children