Posttraumatic Stress DisorderPhase 1/2NCT01934348
Psychological First Aid for Victims of Crime
A Phase 1/2 study testing Psychological First Aid and Usual victim advocacy Services in people with Posttraumatic Stress Disorder and Depression, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
This study aims to implement and refine research protocols required for a full-scale randomized controlled trial of Psychological First Aid (PFA) for adult victims of crime. PFA is a promising acute intervention designed to reduce the severity and duration of trauma-related distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression, Substance Use
- What is being tested?
- Psychological First Aid and Usual victim advocacy Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Dec 2014
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Victim of a rape/sexual assault, physical assault, or armed robbery
- Experience of a physical injury or perceived life threat during the assault
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Charleston County Sheriff's Office
Charleston, South Carolina
City of Charleston Police Department
Charleston, South Carolina
About this study
This study aims to implement and refine research protocols required for a full-scale randomized controlled trial of Psychological First Aid (PFA) for adult victims of crime. PFA is a promising acute intervention designed to reduce the severity and duration of trauma-related distress. Law Enforcement Victim Advocates are being trained to implement PFA with adult crime victims. A pilot trial is comparing PFA to usual victim advocacy services on key psychiatric outcomes from baseline through 4 months post-baseline.
Read the detailed description
Criminal victimization represents a major public health problem in the United States. As many as one-third of adults have been the victim of a violent crime (rape/sexual assault, physical assault, or armed robbery) during their lifetime, and individuals exposed to violence are at risk for developing chronic psychiatric problems, including posttraumatic stress disorder (PTSD), depression, and substance abuse.
The high prevalence of psychopathology among crime victims underscores the importance of effective interventions for this population. As such, considerable work has validated formal treatments for victims who have already developed chronic trauma-related difficulties. Very little effort, however, has been devoted to testing acute interventions that can be implemented soon after a crime event (i.e., within 4 weeks) with the ultimate aim of preventing longer-term psychiatric problems.
Despite the limited research on acute interventions for crime victims, researchers recently developed an acute intervention called Psychological First Aid (PFA) for individuals exposed to natural disasters or other catastrophic events. Important for present purposes, however, researchers have argued that the primary PFA components (Contact and Engagement, Stabilization, Information Gathering, Safety Planning, Practical Assistance, Connection with Social Supports, Information on Coping, and Linkage with Collaborative Services) also have direct relevance for victims of crime. Thus, we propose that PFA could represent an ideal approach for responding to the acute needs of crime victims, with the goal of reducing their risk for development of chronic psychiatric problems. Importantly, although PFA has been strongly advocated by trauma experts, there have been no empirical tests of the model, highlighting the importance of the proposed research.
Thus, this R34 project aims to implement and refine research protocols required for a full-scale randomized controlled trial of PFA for crime victims. Specifically, this project will examine the feasibility of a protocol for recruiting, assessing, and retaining acute crime victims in the study (Aim 1). Additional preliminary work that is essential for treatment research also will be completed, including the development and evaluation of a PFA fidelity instrument (Aim 2) and the refinement and testing of protocols for training paraprofessionals (i.e., Victim Advocates) to deliver PFA with a high level of fidelity (Aim 3). Finally, a controlled pilot study will examine the effects of PFA on the key psychiatric outcomes (Aim 4).
- Conditions
- Posttraumatic Stress Disorder, Depression, Substance Use
- Being tested
- Psychological First Aid, Usual victim advocacy Services
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological First AidBehavioural
Usual victim advocacy ServicesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Psychological First Aid | Experimental | Behavioral intervention delivered to crime victims during 2-3 in-person interactions within 1 month of the assault. Receives: Behavioral: Psychological First Aid |
| Usual victim advocacy services | Active comparator | Standard victim advocacy services delivered to crime victims within 1 month of the assault. Receives: Behavioral: Usual victim advocacy Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the frequency and severity of posttraumatic stress disorder symptoms as measured by the National Stressful Events PTSD Scale
Measured: Baseline, 1-, 2-, & 4-months post-baseline
Change in the frequency and severity of general anxiety, depression, and somatic symptoms as measured by the Brief Symptom Inventory-18
Measured: Baseline, 1-, 2-, & 4-months post-baseline
Change in the frequency and severity of substance use as measured by the Addiction Severity Index-Self Report
Measured: Baseline, 1-, 2-, & 4-months post-baseline
Secondary outcomes (5)
Change in the frequency of exposure to traumatic events as measured by the Trauma Assessment for Adults-Brief Version
Measured: Baseline, 1-, 2-, & 4-months post-baseline
Change in the level of adaptive functioning as measured by the Social Adjustment Scale-Self Report
Measured: 1-, 2-, & 4-months post-baseline
Change in the utilization of formal treatment services as measured by the Service Utilization Form
Measured: 1-, 2-, & 4-months post-baseline
Change in the frequency of contact between Victim Advocates and crime victims as measured by the Advocate Contact Form
Measured: Up to 9 months following randomization of the advocates to the PFA and usual services conditions
Change in the level of PFA implementation by Victim Advocates as measured by the PFA Fidelity Form
Measured: Up to 9 months following randomization of the advocates to the PFA and usual services conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael R. McCart, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934348
- Sponsor's protocol ID
- R34MH091203
- Status last verified
- Aug 2013
- First submitted
- 27 Aug 2013
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological First Aid for Victims of Crime
- ClinicalTrials.gov ID
- NCT01934348
- Acronym / sponsor ID
- R34MH091203
- Conditions
- Posttraumatic Stress Disorder, Depression, Substance Use
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Sep 2013 (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.
This study aims to implement and refine research protocols required for a full-scale randomized controlled trial of Psychological First Aid (PFA) for adult victims of crime. PFA is a promising acute intervention designed to reduce the severity and duration of trauma-related distress. Law Enforcement Victim Advocates are being trained to implement PFA with adult crime victims. A pilot trial is comparing PFA to usual victim advocacy services on key psychiatric outcomes from baseline through 4 months post-baseline.
Detailed description
Criminal victimization represents a major public health problem in the United States. As many as one-third of adults have been the victim of a violent crime (rape/sexual assault, physical assault, or armed robbery) during their lifetime, and individuals exposed to violence are at risk for developing chronic psychiatric problems, including posttraumatic stress disorder (PTSD), depression, and substance abuse.
The high prevalence of psychopathology among crime victims underscores the importance of effective interventions for this population. As such, considerable work has validated formal treatments for victims who have already developed chronic trauma-related difficulties. Very little effort, however, has been devoted to testing acute interventions that can be implemented soon after a crime event (i.e., within 4 weeks) with the ultimate aim of preventing longer-term psychiatric problems.
Despite the limited research on acute interventions for crime victims, researchers recently developed an acute intervention called Psychological First Aid (PFA) for individuals exposed to natural disasters or other catastrophic events. Important for present purposes, however, researchers have argued that the primary PFA components (Contact and Engagement, Stabilization, Information Gathering, Safety Planning, Practical Assistance, Connection with Social Supports, Information on Coping, and Linkage with Collaborative Services) also have direct relevance for victims of crime. Thus, we propose that PFA could represent an ideal approach for responding to the acute needs of crime victims, with the goal of reducing their risk for development of chronic psychiatric problems. Importantly, although PFA has been strongly advocated by trauma experts, there have been no empirical tests of the model, highlighting the importance of the proposed research.
Thus, this R34 project aims to implement and refine research protocols required for a full-scale randomized controlled trial of PFA for crime victims. Specifically, this project will examine the feasibility of a protocol for recruiting, assessing, and retaining acute crime victims in the study (Aim 1). Additional preliminary work that is essential for treatment research also will be completed, including the development and evaluation of a PFA fidelity instrument (Aim 2) and the refinement and testing of protocols for training paraprofessionals (i.e., Victim Advocates) to deliver PFA with a high level of fidelity (Aim 3). Finally, a controlled pilot study will examine the effects of PFA on the key psychiatric outcomes (Aim 4).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological First Aid | Experimental | Behavioral: Psychological First AidBehavioral intervention delivered to crime victims during 2-3 in-person interactions within 1 month of the assault. |
| Usual victim advocacy services | Active comparator | Behavioral: Usual victim advocacy ServicesStandard victim advocacy services delivered to crime victims within 1 month of the assault. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Victim of a rape/sexual assault, physical assault, or armed robbery
- Experience of a physical injury or perceived life threat during the assault
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Psychological First Aid | Behavioural | Psychological First Aid |
| Usual victim advocacy Services | Behavioural | Usual victim advocacy services |
Primary outcome
Change in the frequency and severity of posttraumatic stress disorder symptoms as measured by the National Stressful Events PTSD Scale
Time frame: Baseline, 1-, 2-, & 4-months post-baseline
Change in the frequency and severity of general anxiety, depression, and somatic symptoms as measured by the Brief Symptom Inventory-18
Time frame: Baseline, 1-, 2-, & 4-months post-baseline
Change in the frequency and severity of substance use as measured by the Addiction Severity Index-Self Report
Time frame: Baseline, 1-, 2-, & 4-months post-baseline
5 secondary outcomes
Change in the frequency of exposure to traumatic events as measured by the Trauma Assessment for Adults-Brief Version
Time frame: Baseline, 1-, 2-, & 4-months post-baseline
Change in the level of adaptive functioning as measured by the Social Adjustment Scale-Self Report
Time frame: 1-, 2-, & 4-months post-baseline
Change in the utilization of formal treatment services as measured by the Service Utilization Form
Time frame: 1-, 2-, & 4-months post-baseline
Change in the frequency of contact between Victim Advocates and crime victims as measured by the Advocate Contact Form
Time frame: Up to 9 months following randomization of the advocates to the PFA and usual services conditions
Change in the level of PFA implementation by Victim Advocates as measured by the PFA Fidelity Form
Time frame: Up to 9 months following randomization of the advocates to the PFA and usual services conditions
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 13 Apr 2015.
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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.
Michael R. McCart, Ph.D. principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psychological First Aid and Usual victim advocacy Services in people with Posttraumatic Stress Disorder and Depression, run by Medical University of South Carolina at 2 sites 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 2 inclusion and 0 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Change in the frequency and severity of posttraumatic stress disorder symptoms as measured by the National Stressful Events PTSD Scale (time frame: Baseline, 1-, 2-, & 4-months post-baseline). The study lists 3 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 13 Apr 2015.