- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591694
National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
April 5, 2018 updated by: Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Trauma-informed treatment will improve emotional regulation and behavior.
Study Overview
Status
Completed
Detailed Description
The proposed study is to request permission to continue federally mandated data collection to examine the clinical outcomes of children at the Family Center at Kennedy Krieger Institute who are enrolled in evidence-based and promising trauma-informed treatments as part of the National Child Traumatic Stress Network funded by the Substance Abuse and Mental Health Services Administration.
The purpose of the National Child Traumatic Stress Initiative(NCTSNI) Evaluation is to determine the extent to which the NCTSI, through the National Child Traumatic Stress Network (NCTSN), has raised the standard of care and improved access to services for traumatized children.
In addition, the evaluation assesses the extent to which the NCTSI has served as a national resource capable of improving children's access to high-quality, trauma-informed mental health services.
This data, previously collected and managed by the Category I NCTSN Center at Duke will now be managed by ICF Macro in a data system entitled NICON.
Study Type
Observational
Enrollment (Actual)
4193
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231
- Family Center at Kennedy Krieger Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 89 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children enrolled in treatment at the Family Center and their caregivers
Description
Inclusion Criteria:
- Children enrolled in treatment at the Family Center and caregivers
Exclusion Criteria:
- Psychosis,
- Inability to comply with directions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
FamilyLive
Families with a history of intergenerational trauma (maltreatment, violence exposure, domestic violence, substance abuse, etc.)
|
Yoga Based Psychotherapy
Children with a history of maltreatment and/or violence exposure
|
Biofeedback
Children with a history of maltreatment and violence exposure and their caregivers
|
TST-SA
Trauma Systems Therapy for Adolescent Substance Abuse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavior
Time Frame: 1 year
|
Improved behavioral and emotional regulation, i.e., improved behavior compliance, improved misbehavior symptoms, reduced symptoms of anxiety, depression, attention deficit hyperactivity disorder (ADHD), conduct disorder, oppositional defiant disorder, and post traumatic stress syndrome (PTSD).
Improved sleep, toileting, parent-child attachment, and mood regulation.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Harolyn Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (ACTUAL)
February 7, 2017
Study Completion (ACTUAL)
February 7, 2017
Study Registration Dates
First Submitted
April 9, 2012
First Submitted That Met QC Criteria
May 2, 2012
First Posted (ESTIMATE)
May 4, 2012
Study Record Updates
Last Update Posted (ACTUAL)
April 6, 2018
Last Update Submitted That Met QC Criteria
April 5, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00047384
- 2U79SM056215 (SAMHSA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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