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National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database

This study is currently recruiting participants.
Verified May 2016 by Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591694
First Posted: May 4, 2012
Last Update Posted: May 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  Purpose
Trauma-informed treatment will improve emotional regulation and behavior.

Condition
Post Traumatic Stress Disorder Anxiety Depression Conduct Disorder ADHD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database

Further study details as provided by Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 500
Study Start Date: April 2012
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 89 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children enrolled in treatment at the Family Center and their caregivers
Criteria

Inclusion Criteria:

  • Children enrolled in treatment at the Family Center and caregivers

Exclusion Criteria:

  • Psychosis,
  • Inability to comply with directions
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591694


Locations
United States, Maryland
Family Center at Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21231
Contact: Harolyn M. Belcher, M.D.    443-923-5933      
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Investigators
Principal Investigator: Harolyn Belcher, M.D. Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  More Information

Responsible Party: Harolyn M.E.Belcher, M.D., Director of Research, Kennedy Krieger Family Center; Associate Professor, Johns Hopkins University School of Medicine., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01591694     History of Changes
Other Study ID Numbers: NA_00047384
2U79SM056215 ( U.S. SAMHSA Grant/Contract )
First Submitted: April 9, 2012
First Posted: May 4, 2012
Last Update Posted: May 20, 2016
Last Verified: May 2016

Keywords provided by Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
child trauma
maltreatment
physical abuse
sexual abuse
emotional abuse
abandonment
domestic violence
community violence

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Conduct Disorder
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders