Post Traumatic Stress DisorderNCT01591694
National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
An observational study of Post Traumatic Stress Disorder and Anxiety, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
Trauma-informed treatment will improve emotional regulation and behavior. Read more about this study
- Who is it for?
- Ages 2 to 89 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Anxiety, Depression
- How many people
- 4,193 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 7 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children enrolled in treatment at the Family Center and their caregivers
Who may be able to join
- Children enrolled in treatment at the Family Center and caregivers
Who cannot join
- Psychosis,
- Inability to comply with directions
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Center at Kennedy Krieger Institute
Baltimore, Maryland, 21231
About this study
Trauma-informed treatment will improve emotional regulation and behavior.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder, Anxiety, Depression, Conduct Disorder, ADHD
- Keywords
- child trauma, maltreatment, physical abuse, sexual abuse, emotional abuse, abandonment, domestic violence, community violence
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Conduct Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startApr 2012
- Primary completion7 Feb 2017
- Study completion7 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Harolyn Belcher, M.D., Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591694
- Sponsor's protocol ID
- NA_00047384
- Other IDs
- 2U79SM056215
- Status last verified
- Apr 2018
- First submitted
- 9 Apr 2012
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
- ClinicalTrials.gov ID
- NCT01591694
- Acronym / sponsor ID
- NA_00047384
- Conditions
- Post Traumatic Stress Disorder, Anxiety, Depression, Conduct Disorder, ADHD
- Keywords
- child trauma, maltreatment, physical abuse, sexual abuse, emotional abuse, abandonment, domestic violence, community violence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,193 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- Apr 2012
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trauma-informed treatment will improve emotional regulation and behavior.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children enrolled in treatment at the Family Center and their caregivers
Key inclusion criteria (1 listed)
- Children enrolled in treatment at the Family Center and caregivers
Key exclusion criteria (2 listed)
- Psychosis,
- Inability to comply with directions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harolyn Belcher, M.D. principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder and Anxiety, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.