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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591694
• Other study ID #: NA_00047384
• Secondary ID: 2U79SM056215
• Status: Completed
• First received: April 9, 2012
• Last updated: April 5, 2018
• Start date: April 2012
• Est. completion date: February 7, 2017

Study information

• Verified date: April 2018
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Trauma-informed treatment will improve emotional regulation and behavior.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4193
• Est. completion date: February 7, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 89 Years

Eligibility

Inclusion Criteria:

• Children enrolled in treatment at the Family Center and caregivers

Exclusion Criteria:

• Psychosis,

• Inability to comply with directions

Related Conditions & MeSH terms

• ADHD
• Anxiety
• Conduct Disorder
• Depression
• Disease
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	Family Center at Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior	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