TraumaPhase 3NCT02737488
Helping Children With Trauma
A Phase 3 study testing Trauma Systems Therapy (TST) and Treatment as Usual (TAU) in people with Trauma and Post-Traumatic Stress Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if a trauma treatment called Trauma Systems Therapy (TST) decreases children's mental health symptoms (such as acting out, not controlling their emotions, etc.) as a result of a traumatic event (or events). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Trauma, Post-Traumatic Stress Disorder
- What is being tested?
- Trauma Systems Therapy (TST) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 1 Feb 2017
- Phase
- Phase 3
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of 7 and 17.
- Have experienced a trauma and have symptoms of that trauma for more than 1 month
- Have a legal guardian who is willing to give consent and a primary caregiver who will be available for assessments.
Who cannot join
- Reside outside the study area
- Currently participating in another study
- Do not speak English
- Receive psychotherapy elsewhere
- Have a sibling already participating in the study
- Are acutely suicidal or homicidal
Show all 10Show fewer
- Demonstrate they are in immediate danger
- Legal guardian does not give consent
- If the primary caregiver does not speak English, does not have consistent access to a telephone, does not have the capacity to answer questions, the child will be excluded.
- If a potential subject has started, stopped, or changed a psychotropic medication within 2 weeks of their intake appointment. If the family is willing to wait for 2 weeks the participant may then be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
The purpose of this study is to evaluate if a trauma treatment called Trauma Systems Therapy (TST) decreases children's mental health symptoms (such as acting out, not controlling their emotions, etc.) as a result of a traumatic event (or events). A traumatic event or events can include experiencing or witnessing violence, excessive bullying, war, car accident, serious injury, getting mistreated or anything else that makes one feel scared or frightened. Children/teens who experience traumatic events have been shown to be at higher risk of poor mental and physical health. Trauma can impact family life, school life and interpersonal relationships well into adulthood. Unfortunately, most children who have experienced traumatic events do not undergo treatment. Although promising treatments do exist, most do not address the complexity of trauma, particularly related to ongoing stress and threats to safety in their environments. One hundred and twenty eligible youth will be randomized to receive either treatment with TST at NYU's Child Study Center or trauma treatment as usual (TAU) at a community mental health clinic.
It is hypothesized that:
- Youth receiving TST will demonstrate a greater decrease in Post-Traumatic Stress Disorder (PTSD) symptoms at the 3, 6, and 9-month follow-up assessments compared to youth receiving treatment as usual (TAU) in the community.
- Youth receiving TST will demonstrate a greater decrease in symptoms of depression, anxiety and problem behaviors (aggression, violence, self-destructive behaviors, etc.) at the 3-, 6- and 9-month follow-up assessments compared to youth receiving TAU.
- Youth receiving TST will have fewer acute mental health service events, such as psychiatric hospitalizations and ED visits compared to youth receiving TAU.
- Greater fidelity to the TST model is associated with better treatment outcomes among youth receiving TST.
- Conditions
- Trauma, Post-Traumatic Stress Disorder
- Being tested
- Trauma Systems Therapy (TST), Treatment as Usual (TAU)
- Keywords
- Therapy, Trauma Systems Therapy
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Systems Therapy (TST)Behavioural
Treatment will be delivered by clinicians and trainees working at the CSC who have been trained in delivering TST. Participants who begin treatment in the safety-focused phase will have their treatment sessions in their homes. Whenever a child enters a different phase of treatment, he or she will go to the site for office visits. At the beginning of treatment, TST clinicians will do a brief diagnostic assessment. All documentation that is completed by the clinician as part of TST treatment at the NYU Langone Medical Center will be documented using Epic, a standard of care integrated health information system for patient safety. Although we are not providing the CSC's standard of care in this study,we are replicating standard care as TST is standard care in other settings. Providing medication is part of standard TST treatment and conforms to good usual practice integrated with psychotherapy. Medication will not be prescribed for research purposes.
Treatment as Usual (TAU)Behavioural
Youth in the control group will be referred to a mental health clinic in close proximity to their residence, in order to receive an evaluation and trauma treatment as usually provided. It cannot be specifically determined, in advance, the nature of this treatment.
The clinics will be contacted after the family enrolls to determine if there was a specific protocol followed. An NYU CSC research coordinator will contact the clinic and assist in scheduling the subject's first visit. Families who do not enroll in any community treatment or dropout of treatment will be followed according to the research protocol for data collection. At the 3, 6, and 9 month assessments, the research coordinator will request the patient's records from the community treatment clinic they are attending in order to track and keep record of the youth's treatment modality, progress, and visit frequency.
| Study group | Role | What they receive |
|---|---|---|
| TST | Experimental | Not described Receives: Behavioral: Trauma Systems Therapy (TST) |
| TAU Group | Active comparator | Not described Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA-Post Traumatic Stress Disorder-Reaction Index-DSM-IV (UCLA-PTSD-RI-DSM-IV)
The primary outcome (PTSD symptom severity) will be collected at 3, 6 and 9 months post-randomization in addition to baseline. The effect of TST compared with TAU will be evaluated based on mixed effects model for longitudinal data.
Measured: 9 Months
Child Stress Disorder Checklist (CSDC)
The primary outcome (PTSD symptom severity) will be collected at 3, 6 and 9 months post-randomization in addition to baseline. The effect of TST compared with TAU will be evaluated based on mixed effects model for longitudinal data.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Saxe, MD, Principal investigator, Glenn.Saxe@nyumc.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737488
- Sponsor's protocol ID
- 15-01251
- Status last verified
- Mar 2017
- First submitted
- 8 Apr 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Children With Trauma
- ClinicalTrials.gov ID
- NCT02737488
- Acronym / sponsor ID
- 15-01251
- Conditions
- Trauma, Post-Traumatic Stress Disorder
- Keywords
- Therapy, Trauma Systems Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Feb 2016
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 14 Apr 2016 (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.
The purpose of this study is to evaluate if a trauma treatment called Trauma Systems Therapy (TST) decreases children's mental health symptoms (such as acting out, not controlling their emotions, etc.) as a result of a traumatic event (or events). A traumatic event or events can include experiencing or witnessing violence, excessive bullying, war, car accident, serious injury, getting mistreated or anything else that makes one feel scared or frightened. Children/teens who experience traumatic events have been shown to be at higher risk of poor mental and physical health. Trauma can impact family life, school life and interpersonal relationships well into adulthood. Unfortunately, most children who have experienced traumatic events do not undergo treatment. Although promising treatments do exist, most do not address the complexity of trauma, particularly related to ongoing stress and threats to safety in their environments. One hundred and twenty eligible youth will be randomized to receive either treatment with TST at NYU's Child Study Center or trauma treatment as usual (TAU) at a community mental health clinic.
It is hypothesized that:
- Youth receiving TST will demonstrate a greater decrease in Post-Traumatic Stress Disorder (PTSD) symptoms at the 3, 6, and 9-month follow-up assessments compared to youth receiving treatment as usual (TAU) in the community.
- Youth receiving TST will demonstrate a greater decrease in symptoms of depression, anxiety and problem behaviors (aggression, violence, self-destructive behaviors, etc.) at the 3-, 6- and 9-month follow-up assessments compared to youth receiving TAU.
- Youth receiving TST will have fewer acute mental health service events, such as psychiatric hospitalizations and ED visits compared to youth receiving TAU.
- Greater fidelity to the TST model is associated with better treatment outcomes among youth receiving TST.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TST | Experimental | Behavioral: Trauma Systems Therapy (TST) |
| TAU Group | Active comparator | Behavioral: Treatment as Usual (TAU) |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between the ages of 7 and 17.
- Have experienced a trauma and have symptoms of that trauma for more than 1 month
- Have a legal guardian who is willing to give consent and a primary caregiver who will be available for assessments.
Key exclusion criteria (10 listed)
- Reside outside the study area
- Currently participating in another study
- Do not speak English
- Receive psychotherapy elsewhere
- Have a sibling already participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Systems Therapy (TST)Treatment will be delivered by clinicians and trainees working at the CSC who have been trained in delivering TST. Participants who begin treatment in the safety-focused phase will have their treatment sessions in their homes. Whenever a child enters a different phase of treatment, he or she will go to the site for office visits. At the beginning of treatment, TST clinicians will do a brief diagnostic assessment. All documentation that is completed by the clinician as part of TST treatment at the NYU Langone Medical Center will be documented using Epic, a standard of care integrated health information system for patient safety. Although we are not providing the CSC's standard of care in this study,we are replicating standard care as TST is standard care in other settings. Providing medication is part of standard TST treatment and conforms to good usual practice integrated with psychotherapy. Medication will not be prescribed for research purposes. | Behavioural | TST |
| Treatment as Usual (TAU)Youth in the control group will be referred to a mental health clinic in close proximity to their residence, in order to receive an evaluation and trauma treatment as usually provided. It cannot be specifically determined, in advance, the nature of this treatment. The clinics will be contacted after the family enrolls to determine if there was a specific protocol followed. An NYU CSC research coordinator will contact the clinic and assist in scheduling the subject's first visit. Families who do not enroll in any community treatment or dropout of treatment will be followed according to the research protocol for data collection. At the 3, 6, and 9 month assessments, the research coordinator will request the patient's records from the community treatment clinic they are attending in order to track and keep record of the youth's treatment modality, progress, and visit frequency. | Behavioural | TAU Group |
Primary outcome
UCLA-Post Traumatic Stress Disorder-Reaction Index-DSM-IV (UCLA-PTSD-RI-DSM-IV)
Time frame: 9 Months
The primary outcome (PTSD symptom severity) will be collected at 3, 6 and 9 months post-randomization in addition to baseline. The effect of TST compared with TAU will be evaluated based on mixed effects model for longitudinal data.
Child Stress Disorder Checklist (CSDC)
Time frame: 9 months
The primary outcome (PTSD symptom severity) will be collected at 3, 6 and 9 months post-randomization in addition to baseline. The effect of TST compared with TAU will be evaluated based on mixed effects model for longitudinal data.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
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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.
Glenn Saxe, MD principal investigator
Glenn.Saxe@nyumc.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trauma Systems Therapy (TST) and Treatment as Usual (TAU) in people with Trauma and Post-Traumatic Stress Disorder, run by NYU Langone Health 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 31 Mar 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
UCLA-Post Traumatic Stress Disorder-Reaction Index-DSM-IV (UCLA-PTSD-RI-DSM-IV) (time frame: 9 Months). The study lists 2 primary outcomes in all. 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 31 Mar 2017.