Status:
WITHDRAWN
FamilyLive Feasibility and Effectiveness Study
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborating Sponsors:
Substance Abuse and Mental Health Services Administration (SAMHSA)
Conditions:
Mood Lability
PTSD
Eligibility:
All Genders
5-80 years
Phase:
EARLY_PHASE1
Brief Summary
Children who have been exposed to trauma (defined as physical, sexual or emotional abuse, neglect, exposure to life threatening events, domestic and community violence, parental mental health disorder...
Detailed Description
Children who have been exposed to neglect often have parents who experienced their own childhood neglect and/or trauma (defined as childhood physical, sexual or emotional abuse, exposure to life threa...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Children, ages 5-17 years 11 months,
- enrolled in treatment at KKFC and each child's primary caregiver will be invited to participate if the child continues to exhibit behavior dysregulation (CBCL of \> 60) and/ or attachment difficulties following 3 months of SMHC at the KKFC and if parents have a history of neglect (with or without trauma).
- Exclusion criteria:
- Children with cardiac arrhythmias, endocrine disorders associated with heart rate irregularities or who are not able to cooperate or understand study procedures will be excluded.
- Non-English speaking children or hearing impaired will be excluded.
- Children in foster care.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01524185
Start Date
February 1 2009
End Date
January 8 2016
Last Update
April 9 2018
Active Locations (1)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21231