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Evaluation of an Early Intervention to Prevent Traumatic Stress Reactions in Young Injured Children and their Parents.

Prevention of Post Trauma Reactions in Young Injured Children and their Parents:A Randomised Control Trial of the Early Psychological Intervention in Children after Psychological Trauma (EPICAP).

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000325606
Enrollment
464
Registered
2014-03-26
Start date
2014-06-03
Completion date
2016-07-26
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In Australia, accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Recent research has shown that around 10-30% of young injured children will go on to develop chronic posttraumatic stress disorder (PTSD). Parents of injured children are also at risk of PTSD and this is associated with short and long-term consequences for their child’s physical and psychological recovery. PTSD is a complex and serious disorder that is associated with a range of adverse psychiatric and health outcomes; poorer adherence to medical treatment; reduced wound healing; diminished health-related quality of life; impaired parent-child relationships; and can significantly impact psychological, cognitive, social and neurobiological development. Despite the significance of this problem, to date, the mental health needs of injured young children have been neglected. One reason for this is due to the uncertainty and considerable debate around how to best provide early psychological intervention to traumatised children and adults. In particular, there are currently no published studies on early intervention for young traumatised children. The proposed research therefore aims to evaluate the effectiveness and feasibility of a screening and indicated prevention program for injured young children (1-6 years) and their parents. The study will employ a randomised control trial design and children who are screened as ‘high-risk’ for PTSD and their parents will be randomised to either (1) 2-session face-to-face child and family focused intervention or (2) treatment as usual. Assessment will be completed at baseline (2 weeks), 3 and 6 months post injury. The development, evaluation and dissemination of effective indicated prevention programs for young children and parents have the potential for enormous national and international benefit.

Interventions

This study involves a screen-and-treat design. All eligible families will be screened approximately 1 week after the accident. Families who screen at 'high-risk' will then be randomly allocation to intervention or treatment as usual conditions. Families who screen at 'low-risk' will not need to participate in the intervention. However, these parents will be invited to fill in some brief questionnaires at 2 weeks and 6 months after the accident to monitor the progress of their child over this p

This study involves a screen-and-treat design. All eligible families will be screened approximately 1 week after the accident. Families who screen at 'high-risk' will then be randomly allocation to intervention or treatment as usual conditions. Families who screen at 'low-risk' will not need to participate in the intervention. However, these parents will be invited to fill in some brief questionnaires at 2 weeks and 6 months after the accident to monitor the progress of their child over this period. The intervention will consist of 2 face-to-face sessions (60 min) and 2 follow-up calls or short follow-up face-to-face meetings (5-15 min), respectively. All sessions will be conducted with parents and with children participating when developmentally appropriate. Treatment Session 1 will begin approximately 2 weeks post accident. Follow-up phone-call 1 will be 3 days after Session 1. Session 2 will be conducted 1 week after Session 1 and follow-up call 2 will occur 4 weeks after Session 1. The treatment will be conducted according to a manual that will specify the treatment procedures and timing. The first session aims to: (1) obtain the parent’s story about their child’s accident and medical treatment to normalise experiences and to convey empathy and understanding and to assess level of parental distress (2) provide psychoeducation materials to help parents understand and normalize their own reactions and to promote positive coping (3) provide psychoeducation materials to help parents to understand and normalize the reactions of their child and to identify signs that indicate risk for ongoing problems (4) provide parents with general coping strategies to prevent or manage their child’s distress (5) provide parents with a storybook (‘Max the brave’) to help them talk to their child about accident related experiences and to show how the character successfully copes with the experience (6) give children an Owl Toy “Lu Lu” that they can use for comfort and to feel brave in scary situations and (7) teach parents how to help their child to create an accurate story about the accident and medical treatment and to provide exposure to these memories. The second session aims to (1) educate and normalise how parenting behaviours and the parent-child relationship can change following a child’s accident and help parents to identify any unhelpful behaviours and discuss goals for change and (2) teach parents how to effectively manage their child’s traumatic stress reactions (i.e. Fear and avoidance, Separation anxiety, Tantrums, aggression and disobedience and Sleeping problems).

Sponsors

CONROD, University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

(1) child is admitted to the Royal Children’s Hospital (RCH) Brisbane following an unintentional traumatic injury and (2) child is aged between 1-6 years.

Exclusion criteria

Participants will be excluded if (1) parents’ English is insufficient to complete interviews or questionnaires, (2) child has a Glasgow Coma Scale < 12, (3) injury was a result of suspected child abuse or neglect, and/or (4) child has a pervasive developmental disorder.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 12, 2026