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

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT01591694
Collaborator
(none)
4,193
Enrollment
1
Location
58.3
Duration (Months)
72
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Trauma-informed treatment will improve emotional regulation and behavior.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    4193 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
    Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    Feb 7, 2017
    Actual Study Completion Date :
    Feb 7, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Behavior [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children enrolled in treatment at the Family Center and caregivers
    Exclusion Criteria:

    • Psychosis,

    • Inability to comply with directions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Family Center at Kennedy Krieger Institute Baltimore Maryland United States 21231

    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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None 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
    Other Study ID Numbers:
    • NA_00047384
    • 2U79SM056215
    First Posted:
    May 4, 2012
    Last Update Posted:
    Apr 6, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by 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.
    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

    Study Results

    No Results Posted as of Apr 6, 2018