RecruitingACTRN12619000914167

Evaluation of the effectiveness of Coping with Accident REactions (CARE) screen and-treat early intervention for improving recovery from trauma reactions in young injured children and their parents

Pragmatic Randomised Control Trial of the Coping with Accident REactions (CARE) screen and-treat early intervention for facilitating faster recovery from acute traumatic stress reactions in young injured children and their parents

Sponsor

University of Queensland

Enrollment

120 participants

Start Date

Apr 12, 2019

Study Type

Interventional

Conditions

Mental Health Posttraumatic Stress Disorder Injury

Summary

Approximately 10-30% of young children are at high-risk of experiencing posttraumatic stress disorder (PTSD), anxiety, mood and/or behavioural disorders following a traumatic injury. We have developed and found support for the efficacy of the Coping with Accident Reactions (CARE) early intervention at accelerating the recovery from PTSD symptoms for young injured children (1-6 years). The aim of this pragmatic trial is demonstrate the effectiveness of the screen-and-treat CARE intervention program when delivered by hospital staff as part of routine clinical care.

Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

When very young children experience a traumatic injury — a serious accident, fall, or collision — they can develop lasting emotional and psychological difficulties, including post-traumatic stress disorder (PTSD). Parents are also significantly affected. Around 10–30% of injured children aged 1–6 are at high risk of developing these problems. The CARE (Coping with Accident Reactions) program is an early intervention developed specifically for toddlers and young children that helps both the child and their parents manage the emotional aftermath of trauma. This study is testing whether the CARE program, delivered by trained hospital staff as part of routine clinical care, effectively reduces PTSD symptoms and psychological distress in young children and their families. Children aged 1–6 presenting to Queensland Children's Hospital after an unintentional injury will be screened for trauma risk and, if appropriate, offered the program. Eligibility is for children aged 1–6 who have been seen at the hospital after an accidental traumatic injury, with families who speak sufficient English to participate and whose situation is not assessed as too complex for the program. This study could help establish early psychological intervention as a standard part of paediatric trauma care, potentially preventing years of mental health difficulties for young injury survivors and their families.

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Interventions

The CARE intervention consists of a 2 session manualised treatment protocol, with Session 1 providing (1) psychoeducation to normalise parent and child reactions, (2) coping strategies to manage distress, and (3) resources to help parents and children develop an accurate narrative about the accident and medical treatment. Session 2 consists of (1) monitoring child and parent distress; (2) educating how parenting and parent-child relationships can change following an accident, helping parents identify unhelpful behaviours and discuss goals for change; and (3) teaching parents how to manage their child’s symptoms. The sessions are conducted following the baseline diagnostic assessment approximately 2-4 weeks post injury. Sessions are 45-60 minutes in duration and conducted 1 week apart. A brief follow-up phone session at 6-weeks is offered to check in with families and provide referral information if needed. Resources developed for the intervention include information booklets, Max the Brave (a storybook about a boy who goes to hospital after an injury), LuLu the Owl toy, and a personal storybook template. In running the efficacy trials and following protocol such that all families completed all sessions and modules, we discovered that many families did not require all modules of the intervention, and children often preferred one resource over another (e.g. liked Max the Brave, didn’t use LuLu the Owl). Using this information to inform the current trial, therapists will now choose the most appropriate treatment modules and resources on a case-by-case basis, tailoring the intervention to each family. The intervention will be delivered up to a maximum equivalent of two 90-minute sessions conducted with the primary caregiver(s), delivered via telephone, skype or face-to-face, as preferred by the family to facilitate access. Fidelity: Clinical psychologists (with a minimum of master’s level training) from the Queensland Children's Hospital will be the therapists delivering the intervention. They will undergo a full-day training workshop on trauma during early childhood, paediatric medical traumatic stress, and the CARE intervention by the co-developer of the intervention. Clinical supervision will be held at the completion of each intervention session. As this intervention is been delivered by hospital staff as part of routine clinical care it will not be possible to record (audio or video) and review sessions. However, therapists will be required to complete treatment adherence checklists at the end of each session.