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Coping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: study protocol for two randomised controlled trials.

ABSTRACT: Accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Around 10-30 % of young injured children will go on to develop post-traumatic stress disorder (PTSD) and other co-morbid conditions. Parents of injured children are also at risk of PTSD, and this is associated with short- and long-term consequences for their children's physical and psychological recovery. 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. To address these gaps, researchers and psychologists in Australia and Switzerland have developed the Coping with Accident Reactions (CARE) programme, which is a two-session early intervention designed to prevent persistent PTSD reactions in young injured children screened as 'at risk'. Two separate international studies are being conducted to evaluate the effectiveness and feasibility of this programme.The study design for the two proposed studies will employ a randomised controlled trial design and children (aged 1-6 years) who are screened as at risk for PTSD 1 week after an unintentional injury, and their parents will be randomised to either (1) CARE intervention or (2) treatment as usual. Assessment will be completed at baseline (2 weeks) and 3 and 6 months post-injury.This international collaboration provides an excellent opportunity to test the benefit of screening and providing early intervention to young children in two different countries and settings. It is expected that outcomes from this research will lead to significant original contributions to the scientific evidence base and clinical treatment and recovery of very young injured children.The Australian study was registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12614000325606 ) on 26 March 2014. The Swiss study was registered with ClinicalTrials.gov ( NCT02088814 ) on 12 March 2014.

SUBMITTER: De Young AC

PROVIDER: S-EPMC4964020 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Coping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: study protocol for two randomised controlled trials.

De Young Alexandra C AC Haag Ann-Christin AC Kenardy Justin A JA Kimble Roy M RM Landolt Markus A MA

Trials 20160728

<h4>Background</h4>Accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Around 10-30 % of young injured children will go on to develop post-traumatic stress disorder (PTSD) and other co-morbid conditions. Parents of injured children are also at risk of PTSD, and this is associated with short- and long-term consequences for their children's physical and psychological recovery. Despite the significance of this problem, to date, the ...[more]

PMID: 27464735

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Project description:Trial sponsorBangor University, Brigantia Building, College Road, Bangor, LL57 2AS, UK INTRODUCTION: The COPING parent online universal programme is a web-based parenting intervention for parents of children aged 3-8 years with an interest in positive parenting. The programme focuses on strengthening parent-child relationships and encouraging positive child behaviour. This trial will evaluate whether the intervention is effective in increasing the use of positive parenting strategies outlined in the programme using parent report and blind observation measures.Methods and analysisThis is a pilot randomised controlled trial with intervention and wait-list control conditions. The intervention is a 10-week online parenting programme to promote positive parent-child relations by teaching core social learning theory principles that encourage positive child behaviour, primarily through the use of praise and rewards. Health visitors and school nurses will circulate a recruitment poster to parents of children aged 3-8 years on their current caseloads. Recruitment posters will also be distributed via local primary schools and nurseries. Parents recruited to the trial will be randomised on a 2:1 ratio to intervention or wait-list control conditions (stratified according to child gender and age). The primary outcome measure is positive parenting as measured by a behavioural observation of parent-child interactions using the Dyadic Parent-Child Interaction Coding System. Secondary outcomes include parent report of child behaviour, and self-reported parental sense of competence, parenting behaviour and parental mental health. Data will be collected at baseline and 3 months later (postintervention) for all participants and 6 months postbaseline for the intervention group only. Analysis of covariance will be the main statistical method used.Ethics and disseminationThe trial has received ethical approval from the NHS Betsi Cadwaladr University Health Board Ethics Committee (REC) and the School of Psychology, Bangor University REC (15/WA/0463). Publication of all outcomes will be in peer-reviewed journals and conference presentations.Trial registration numberCurrent Controlled Trials ISRCTN89370147 (5 May 2016).

Project description:BackgroundPrevious research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios.MethodsData on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each trial's primary results was classified into six categories; 1) statistically significant in favour of the new treatment, 2) statistically significant in favour of the control treatment 3) true negative, 4) truly inconclusive, 5) inconclusive in favour of new treatment or 6) inconclusive in favour of control treatment. Trials were classified by comparing the 95% confidence interval for the difference in primary outcome to the difference specified in the sample size calculation. The results were compared with Djulbegovic's analysis of NCI trials.ResultsData from 51 superiority trials were included, involving over 48,000 participants and a range of diseases and interventions. 85 primary comparisons were available because some trials had more than two randomised arms or had several primary outcomes. The new treatment had superior results (whether significant or not) in 61% of the comparisons (52/85 95% CI 49.9% to 71.6%). The results were conclusive in 46% of the comparisons (19% statistically significant in favour of the new treatment, 5% statistically significant in favour of the control and 22% true negative). The results were classified as truly inconclusive (i.e. failed to answer the question asked) for 24% of comparisons (20/85). HTA trials included fewer truly inconclusive and statistically significant results and more results rated as true negative than NCI trials.ConclusionsThe pattern of results in HTA trials is similar to that of the National Cancer Institute portfolio. Differences that existed were plausible given the differences in the types of trials -HTA trials are more pragmatic. The results indicate HTA trials are compatible with equipoise. This classification usefully summarises the results from clinical trials and enables comparisons of different portfolios of trials.

Project description:Background: Post-traumatic stress disorder (PTSD) occurs after exposure to actual or threatened death, serious injury, or sexual violence. Road traffic accident (RTA) is one of the traumatic experiences, which may result in PTSD. But treatment is mainly concentrated on physical health. This may be due to a lack of evidence in low-income countries. Aim: To determine the incidence level and identify risk factors of PTSD after RTA. Methods: Longitudinal panel study was done to assess the incidence of PTSD after RTA. The study was conducted in three orthopedic settings of Bahir Dar town Northwest, Ethiopia. The study was on 299 adult car accident survivors. PTSD Checklist (PCL) civilian version, Sheehan disability assessment scale, Patient Health Question (PHQ-2), and Alcohol Use Disorder Identification Test (AUDIT) were instruments to assess the outcome and associated factors. The generalized linear model with Poisson log-linear method was applied to identify associated factors. Ethical clearance was obtained from Bahir Dar University. Individuals with PTSD symptoms were linked to the psychiatric clinic. Result: One hundred thirty-nine (46.5%) participants had at least three extremely severe symptoms that fulfil criteria B, C, and D of Diagnostic Statistical Manual IV of PTSD. The most frequent severe symptoms were having repeated, disturbing memories, thoughts, or images. Two hundred ten (70.2%) participants reported the extreme impact of the accident on work or schooling and 156 (51.9%) reported extreme problems in social functioning. Alcohol dependence, hazardous alcohol consumption, and harmful use were reported by 7.9%, 15.1%, and 4.7% of the participants, respectively. In the final model witnessing death, severe sleep problem and severe impairment in family functioning were significantly associated with PTSD. Conclusion: Nearly half of RTA survivors develop PTSD. Clinicians need to link these patients to the psychiatry clinic. Special attention should be given to patients who witnessed death, with a serious disability, and previous psychiatric history.

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Coping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: study protocol for two randomised controlled trials.

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Coping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: study protocol for two randomised controlled trials.

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