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

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

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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