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5.8.2 Developing a Site-Specific Protocol for Parent Notification and Follow Up Care
Each center will establish a written protocol describing the above procedure. If the study
psychologist is not available, arrangements will be made for another local, licensed
psychologist to cover. The protocol also will establish whether/how the Site PI and
Coordinator will be contacted.
This protocol also will establish specifics, consistent with local IRB, on how/who will
determine whether the child meets exclusion criteria:
”Psychiatric or behavioral disorders requiring initiation of new medication, therapy, or
other specific treatment during the 12 month trial period.”
Those who are deemed at imminent risk of suicidality will be referred to the nearest
psychiatric emergency center
If a child does not note an immediate intent for self-harm, the parent will be given mental
health referral information
Report findings on Neuropsychological Abnormal Test Log (NPAB), including CDI score
and check mark for Item 9 if equal to response of “3.”
After family/child contact, check the appropriate boxes on Administrative Form (NPAB)
related to the status of Follow-Up procedures for the child (i.e., “Parent Informed?”, “Site
PI Informed?”, “DCC Informed?”, “Follow-UP?”)