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Table 2 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2013) schedule of study recruitment, intervention and assessments

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

 

Study period

 

Enrolment

Allocation

Post-allocation

Timepoint

-t1

0

t1

t2

t3

Enrolment:

     

 Eligibility screen

X

    

 Informed consent

X

    

 Allocation to risk condition

 

X

   

Interventions:

     

 CARE Intervention

  

X

  

Assessments:

     

 Demographic variables

 

X

   

 Pediatric Emotional Distress Scale Early Screener

 

X

   

 Diagnostic Infant Preschool Assessment

  

X

X

X

 Young Child PTSD Checklist

  

X

X

X

 Child Behavior Checklist for ages 1.5-5

  

X

X

X

 Posttraumatic diagnostic scale

  

X

X

X

 Injury related variables

    

X

  1. 0 Allocation to the high-risk or low-risk condition occurs via completion of the screener at 6–8 days post- injury. t1 9–11 days post-injury, t2 3 months post-injury, t3 6 months post-injury