PTSDSMSCNCT04752618
Safe Mothers, Safe Children Initiative
A study testing P-STAIR and Supportive Counseling in people with PTSD and Depression, run by New York University at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Depression, Child Maltreatment
- What is being tested?
- P-STAIR and Supportive Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving preventive services at the time of the consent session to participate in the study
- Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-5)
- Having 1-10-year-old child
- Being the legal guardian for the child with physical and legal custody
- Being able to read, write, and speak English or Spanish
- Must be a currently or formerly hired Study Clinician or Clinical Director with Safe Mothers, Safe Children.
Who cannot join
- Having suicidal ideation present in the past month prior to pre-assessment or reports of a suicide attempt in the past year (SCID-5)
- Meeting a diagnosis of severe substance or alcohol use disorder (≥ 6 symptoms on SCID) AND not in early remission (≥3 months without meeting any substance or alcohol use disorder criteria (except craving)
- Having current or active symptoms of psychosis in the past month
- Having a disability affecting communication, such as deafness
- Having an index child with a developmental condition that impedes cognitive and/or physical functioning, e.g. autism
- Having an index child with current symptoms or diagnosis of psychosis as defined by the DSM-5 in the past 3 months
Show all 9Show fewer
- Experiencing current or history of intimate partner violence (IPV) or family violence:
- If there is a history of IPV/family violence and the relationship is no longer active, the relationship must have ended for at least ninety days with no intention of restarting; If there is a history of IPV/family violence, but the relationship is ongoing, there must not have been an IPV/family violence event for at least one year
- There are no exclusion criteria for this population. Participants in this population will cease completion of therapist-copy measures upon the conclusion of their role with Safe Mothers, Safe Children, or upon withdrawal from participation in these measures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McSilver Institute for Poverty Policy and Research
New York, New York, 10003
Michael A Lindsey, 212-998-5927, ml4361@nyu.edu
Ammu Kowolik, ammu@nyu.edu
About this study
Official title: Treating Maternal PTSD to Enhance and Reduce Maltreatment Recidivism: Safe Mothers, Safe Children
The purpose of this study is to assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.
Read the detailed description
This study is a two-arm randomized controlled trial (RCT): P-STAIR (23 sessions) vs. supportive counseling (SC) (23 sessions). Eligible cases are randomized to P-STAIR and SC in a 1:1 ratio. Participants will be mothers receiving family preservation services (FPS), with a child in the age range of 1-10 years old, and PTSD (with/without depression). Symptom progress will be measured at pre-treatment, two in-treatment assessments (9 weeks and 16 weeks), post-treatment, and at a 6-month follow-up.
Study clinicians who deliver the study interventions are also considered participants in SMSC. They are not randomized to treatment arms; they are assigned to work with participants in both treatment arms. The study clinicians complete therapist-versions of certain assessment measures throughout the course of the study in order for researchers to assess the working relationship between study clinicians and the mothers they are administering treatment to.
- Conditions
- PTSD, Depression, Child Maltreatment
- Being tested
- P-STAIR, Supportive Counseling
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-STAIRBehavioural
PCIT+ STAIR
Supportive CounselingBehavioural
Non-trauma focused psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| P-STAIR | Experimental | Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. P-STAIR is a combination of STAIR and PCIT. STAIR focuses on reduction of PTSD symptoms through enhancement of emotion regulation skills. PCIT focuses on the reduction of negative parenting skills and the increase of positive parenting skills. Receives: Behavioral: P-STAIR |
| Supportive Counseling | Active comparator | Participants will receive 23 weekly individual treatment sessions. Each session will last one hour. Supportive counseling has been modified to permit non-trauma discussion of parenting problems. Each session is client-directed and clinicians take an unconditionally supportive role. Receives: Behavioral: Supportive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5)
Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) is a 24-item self-report measure of PTSD symptoms over the last month. Items are rated on a 5-point scale of frequency and severity ranging from 0 ("not at all") to 4 ("6 or more times a week/severe"). Higher scores indicate more severe PTSD symptoms. PDS-5 will be used to monitor change in PTSD symptoms over treatment implementation. PDS-5 is also used during the baseline to evaluate for inclusion/exclusion criteria.
Measured: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Center for Epidemiological Studies-Depression (CES-D)
Center for Epidemiological Studies-Depression (CES-D) is a 20-item self-report measure of symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Items are rated on a 3-point scale ranging from 0 ("rarely or none of the time") to 3 ("most or almost all of the time"). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D will be used to assess change in depression symptoms over treatment implementation.
Measured: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Dyadic Parent-Child Interaction Coding System-IV (DPICS)
Dyadic Parent-Child Interaction Coding System-IV (DPICS) examines the quality of parent-child social interaction in three 5-minute situations: child-directed play, parent-directed play, and clean-up. Positive skills include praise, reflect, and describe, and negative skills include questions, commands, and criticisms. Observations are coded by trained DPICS scorers to produce total scores. DPICS scores allow us to track the changes in positive and negative parenting scores over treatment implementation.
Measured: Change from baseline (pre-treatment) to mid-treatment at session 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
New foster care removals
Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of out-of-home placements for 10 years for completers and non-completers who have consented into the study. Number of new foster care removals are located by unique NYSCWR identifiers collected at time of consent. Out-of-home placement data, in addition to new substantiated welfare reports, will be used to assess recidivism.
Measured: Every six-months for 10 years
New child abuse/neglect welfare reports
Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of substantiated abuse/neglect reports for 10 years for completers and non-completers who have consented into the study. Number of new substantiated reports are located by unique NYSCWR identifiers collected at time of consent. New substantiated welfare reports, as well as out-of-home placement data, will be used to assess recidivism.
Measured: Every six-months for 10 years
Family Preservation Services Usual Care (FPSUC) reports
Family Preservation Services Usual Care (FPSUC) is extracted from electronic records that agencies use to document services. FPSUC details the number of services accessed in preventative agencies for clients. Data will be used to statistically control for FPSUC.
Measured: Throughout study completion, an average 43 weeks
Secondary outcomes (9)
Structured Clinical Interview for DSM-5 (SCID-5)
Structured Clinical Interview for DSM-5 (SCID-5) is the gold standard for determining DSM-5 Axis I current diagnoses and psychiatric history. The SCID-5 alcohol and substance use and psychosis modules will be used. SCID-5 will be used to track changes in substance use/abuse and symptoms of psychosis, as well as to evaluate inclusion/exclusion criteria.
Measured: Change from baseline (pre-treatment) to mid-treatment at session 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Difficulties in Emotion Regulation Scale (DERS)
Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure used to assesses emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation. DERS has adequate construct and predictive validity and good test-retest reliability. DERS will be used to evaluate level of emotion regulation skills during treatment implementation.
Measured: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1)
Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1) is a self-reporting inventory that measures parental behaviors and is commonly used to assess the risk of child abuse and neglect. Items are rated on a scale of 1 ("strongly agree") to 5 ("strongly disagree"). AAPI-2.1 has five sub-constructs: expectations of children, parental empathy towards children's needs, use of corporal punishment, parent-child family roles, and children's power and independence. Higher scores indicate lower risk of parental abuse/neglect. AAPI will be used to monitor the change in parental behaviors over treatment implementation.
Measured: Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up
Treatment Services Review (TSR)
Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment and treatment received one year prior to the time of the baseline (pre) assessment. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.
Measured: Baseline (pre-treatment)
Treatment Services Review (TSR)
Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment and treatment received during treatment implementation. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.
Measured: End of treatment (an average 43 weeks)
Treatment Services Review (TSR)
Treatment Services Review (TSR) is an interview used to gather information about specific mental health services received outside of the study treatment and treatment received between the end of treatment and the six-month follow-up assessment. It describes treatment type (individual therapy vs. group), provider type (psychologist, psychiatrist, social worker), length (in years) and frequency of treatment (rate of appointments), rate of hospitalizations, and medications prescribed.
Measured: Follow-up after treatment completion (six-months after end of treatment)
Therapy Acceptability and Expectations (TAE)
Therapy Acceptability and Expectations (TAE) is a 5-item scale that evaluates credibility and engagement of study treatment. Items range from 0 ("not at all") to 8 ("extremely"). Higher scores indicate greater acceptability of treatment. TAE is administered throughout treatment in order to assess the clinician-client therapeutic relationship and client engagement with treatment. Necessary changes that arise from the TAE are addressed in future treatment sessions.
Measured: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Strengths and Difficulties Questionnaire (SDQ)
Strengths and Difficulties Questionnaire (SDQ) is a 25-item parent-report behavioral screening questionnaire that comprises five sub-scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Items have the following responses: "not true," "somewhat true," and "certainly true." Higher scores indicate a higher likelihood of emotional and/or behavioral difficulties. SDQ will be used throughout treatment to assess change in behavior of the child participating in the parent-child dyadic play observations.
Measured: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Working Alliance Inventory Short Form (WAI-S)
The WAI-S is a 12-item measure assessing three key aspects of the therapeutic alliance: agreement on the tasks of therapy, agreement on the goals of therapy, and development of an affective bond. Item responses range from 1 ("Never") to 7 ("Always"). Higher scores indicate a higher quality of the therapeutic alliance. The WAI-S is administered throughout treatment beginning at mid-treatment in order to assess the working relationship between a client and their treating clinician, from both the participant and clinician perspectives.
Measured: Change from mid-treatment at session 9 and 16 to upon completion of treatment (an average of 15 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 May 2021
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by New York UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- P-STAIR vs Supportive Counseling
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Lindsey, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752618
- Sponsor's protocol ID
- IRB-FY2021-5220
- Acronym
- SMSC
- Status last verified
- Nov 2025
- First submitted
- 29 Jan 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Maternal PTSD to Enhance and Reduce Maltreatment Recidivism: Safe Mothers, Safe Children
- ClinicalTrials.gov ID
- NCT04752618
- Acronym / sponsor ID
- SMSC / IRB-FY2021-5220
- Conditions
- PTSD, Depression, Child Maltreatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 12 Feb 2021 (actual)
- 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 assess the efficacy of the combined interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Interaction Therapy (PCIT) or P-STAIR, for treating maternal PTSD and reducing maltreatment recidivism.
Detailed description
This study is a two-arm randomized controlled trial (RCT): P-STAIR (23 sessions) vs. supportive counseling (SC) (23 sessions). Eligible cases are randomized to P-STAIR and SC in a 1:1 ratio. Participants will be mothers receiving family preservation services (FPS), with a child in the age range of 1-10 years old, and PTSD (with/without depression). Symptom progress will be measured at pre-treatment, two in-treatment assessments (9 weeks and 16 weeks), post-treatment, and at a 6-month follow-up.
Study clinicians who deliver the study interventions are also considered participants in SMSC. They are not randomized to treatment arms; they are assigned to work with participants in both treatment arms. The study clinicians complete therapist-versions of certain assessment measures throughout the course of the study in order for researchers to assess the working relationship between study clinicians and the mothers they are administering treatment to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- P-STAIR vs Supportive Counseling
| Arm | Type | Receives |
|---|---|---|
| P-STAIR | Experimental | Behavioral: P-STAIRParticipants will receive 23 weekly individual treatment sessions. Each session will last one hour. P-STAIR is a combination of STAIR and PCIT. STAIR focuses on reduction of PTSD symptoms through enhancement of emotion regulation skills. PCIT focuses on the reduction of negative parenting skills and the increase of positive parenting skills. |
| Supportive Counseling | Active comparator | Behavioral: Supportive CounselingParticipants will receive 23 weekly individual treatment sessions. Each session will last one hour. Supportive counseling has been modified to permit non-trauma discussion of parenting problems. Each session is client-directed and clinicians take an unconditionally supportive role. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Receiving preventive services at the time of the consent session to participate in the study
- Meeting a severity score of 28 or higher OR probable DSM-5 diagnostic criteria for PTSD (PDS-5)
- Having 1-10-year-old child
- Being the legal guardian for the child with physical and legal custody
- Being able to read, write, and speak English or Spanish
Key exclusion criteria (9 listed)
- Having suicidal ideation present in the past month prior to pre-assessment or reports of a suicide attempt in the past year (SCID-5)
- Meeting a diagnosis of severe substance or alcohol use disorder (≥ 6 symptoms on SCID) AND not in early remission (≥3 months without meeting any substance or alcohol use disorder criteria (except craving)
- Having current or active symptoms of psychosis in the past month
- Having a disability affecting communication, such as deafness
- Having an index child with a developmental condition that impedes cognitive and/or physical functioning, e.g. autism
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 |
|---|---|---|
| P-STAIRPCIT+ STAIR | Behavioural | P-STAIR |
| Supportive CounselingNon-trauma focused psychotherapy | Behavioural | Supportive Counseling |
Primary outcome
Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5)
Time frame: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) is a 24-item self-report measure of PTSD symptoms over the last month. Items are rated on a 5-point scale of frequency and severity ranging from 0 ("not at all") to 4 ("6 or more times a week/severe"). Higher scores indicate more severe PTSD symptoms. PDS-5 will be used to monitor change in PTSD symptoms over treatment implementation. PDS-5 is also used during the baseline to evaluate for inclusion/exclusion criteria.
Center for Epidemiological Studies-Depression (CES-D)
Time frame: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Center for Epidemiological Studies-Depression (CES-D) is a 20-item self-report measure of symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Items are rated on a 3-point scale ranging from 0 ("rarely or none of the time") to 3 ("most or almost all of the time"). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. CES-D will be used to assess change in depression symptoms over treatment implementation.
Dyadic Parent-Child Interaction Coding System-IV (DPICS)
Time frame: Change from baseline (pre-treatment) to mid-treatment at session 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Dyadic Parent-Child Interaction Coding System-IV (DPICS) examines the quality of parent-child social interaction in three 5-minute situations: child-directed play, parent-directed play, and clean-up. Positive skills include praise, reflect, and describe, and negative skills include questions, commands, and criticisms. Observations are coded by trained DPICS scorers to produce total scores. DPICS scores allow us to track the changes in positive and negative parenting scores over treatment implementation.
New foster care removals
Time frame: Every six-months for 10 years
Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of out-of-home placements for 10 years for completers and non-completers who have consented into the study. Number of new foster care removals are located by unique NYSCWR identifiers collected at time of consent. Out-of-home placement data, in addition to new substantiated welfare reports, will be used to assess recidivism.
New child abuse/neglect welfare reports
Time frame: Every six-months for 10 years
Data is collected through the New York State Child Welfare Registry (NYSCWR) semi-annually on the number of substantiated abuse/neglect reports for 10 years for completers and non-completers who have consented into the study. Number of new substantiated reports are located by unique NYSCWR identifiers collected at time of consent. New substantiated welfare reports, as well as out-of-home placement data, will be used to assess recidivism.
Family Preservation Services Usual Care (FPSUC) reports
Time frame: Throughout study completion, an average 43 weeks
Family Preservation Services Usual Care (FPSUC) is extracted from electronic records that agencies use to document services. FPSUC details the number of services accessed in preventative agencies for clients. Data will be used to statistically control for FPSUC.
9 secondary outcomes
Structured Clinical Interview for DSM-5 (SCID-5)
Time frame: Change from baseline (pre-treatment) to mid-treatment at session 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Adult Adolescent Parenting Inventory-2.1 (AAPI-2.1)
Time frame: Change from baseline (pre-treatment) to end of treatment (average 43 weeks) to six-month follow-up
Treatment Services Review (TSR)
Time frame: Baseline (pre-treatment)
Treatment Services Review (TSR)
Time frame: End of treatment (an average 43 weeks)
Treatment Services Review (TSR)
Time frame: Follow-up after treatment completion (six-months after end of treatment)
Therapy Acceptability and Expectations (TAE)
Time frame: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion
Working Alliance Inventory Short Form (WAI-S)
Time frame: Change from mid-treatment at session 9 and 16 to upon completion of treatment (an average of 15 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Michael A Lindsey principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P-STAIR and Supportive Counseling in people with PTSD and Depression, run by New York University 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin A Montion, MA ((929) 489-1501, em5935@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic Stress Diagnostic Scale for the DSM-5 (PDS-5) (time frame: Change from baseline (pre-treatment) to mid-treatment at session 9 and 16 to upon completion of treatment (an average of 43 weeks) to six-month follow-up after treatment completion). The study lists 6 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 7 May 2026.