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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Information provided by (Responsible Party):
Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01591694
First received: April 9, 2012
Last updated: September 26, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • Behavior [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 2018
Estimated Primary Completion Date: September 2016 (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

Ages Eligible for Study:   2 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 9, 2012
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by 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:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Depression
Conduct Disorder
Disease
Anxiety Disorders
Mental Disorders
Behavioral Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014