Sex TraffickingNCT03611998
Survivors of Sex Trafficking: Occupation-Based Interventions for Executive Functioning
A study testing Occupation-based programming in people with Sex Trafficking and Mental Disorder, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
Persons traumatized through sex trafficking can demonstrate similar neurobehavioral and executive function (EF) deficits as persons with cortical injuries. In this pilot study, occupation-based activity (OBA) programming was implemented at a residence for females who had been trafficked. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Sex Trafficking, Mental Disorder
- What is being tested?
- Occupation-based programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 30 Apr 2017
- Phase
- Interventional
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant had to be a resident of the performance site and have a history of being sex-trafficked.
Who cannot join
- Participants were not enrolled if behavioral issues prevented participation or impacted the safety of others as determined by resident directors
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
About this study
Persons traumatized through sex trafficking can demonstrate similar neurobehavioral and executive function (EF) deficits as persons with cortical injuries. In this pilot study, occupation-based activity (OBA) programming was implemented at a residence for females who had been trafficked. The study hypothesis was that OBA would facilitate development of EF skills in these clients, enabling more successful occupational performance. Method: Eight women engaged in OBA sessions over the course of eight months. Session objectives were to maximize independence in daily life skills and to foster EF component skills such as problem-solving, decision-making, cooperation, direction following and appropriate self-expression. Outcome measures used were the Executive Function Performance Test (EFPT), the Canadian Occupational Performance Measure (COPM) and the Occupational Therapy Task Observation Scale (OTTOS). Results: Gains were seen from baseline to final session in COPM score changes meeting minimally clinical difference, and OTTOS scores showing significant improvement: t(7)= -2.49, p=.04. Preliminary findings suggest that occupation-based programming may facilitate development of EF skills in sex-trafficked women.
Read the detailed description
Individuals who are sex-trafficked experience a combination of sexual violence, emotional trauma, and physical injuries that lead to high rates of depression, anxiety and post traumatic stress disorder (PTSD) Prolonged stress and adverse learning experiences can also cause use-dependent brain changes that influence executive functioning (EF) development. Other distressing situations, such as living in poverty or in dangerous environments and experiencing early sexual trauma, can result in interrupted development of executive functioning skills Although the current OT literature in the area of human and sex trafficking provide recommendations regarding areas of advocacy, education and occupation-based interventions, there is no empirical evidence to date investigating the efficacy of occupation-based interventions with survivors of sex trafficking (SST). The research question addressed in this pilot study was whether occupation-based interventions would improve the overall occupational performance of SST living in a residential program. Therefore, the purpose was to objectively determine the efficacy of occupation-based activity to improve EF skills in SST; the researchers expected that an improvement in EF skills would translate to improved occupational performance.
This pilot study used a one-group, pretest-posttest design. Participants in the study were residents of a local residential program for survivors of sex trafficking (SST). Eight women, average age, 20 to 50 years who were living in the home during the eight-month project period, engaged in the occupation-based intervention groups provided and completed assessment outcome measures (Canadian Occupational Performance Measure and the Executive Function Performance Test) before and after completing the program. Group behavior was scored at each session attended with the Occupational Therapy Task Observation Scale (OTTOS). Group sessions consisted of specific tasks performed to completion that emphasized problem-solving, decision-making, frustration tolerance and cooperation.
Current performance level rating and performance satisfaction scores from the COPM, as well as scores from each area of the EFPT, were collected upon initial evaluation and at the end of the eight-month intervention period. OTTOS scores were recorded during each group intervention for individual clients and graphically recorded to demonstrate individual changes over time; day one OTTOS scores were compared to the OTTOS score of the final intervention. All comparisons were completed using two-tailed, paired t-tests with a .05 alpha level for significance.
- Conditions
- Sex Trafficking, Mental Disorder
- Being tested
- Occupation-based programming
- Keywords
- Sex trafficking, Occupational therapy, Occupation-based programming, Activity-based programming, Brain trauma
- Medical subject headings
- Mental Disorders, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupation-based programmingBehavioural
Group sessions consisted of specific tasks performed to completion that emphasized skills such as problem-solving, decision-making, frustration tolerance, appropriate pacing, attention, inquiring, sequencing, gathering, organizing, adjusting, responding, enduring, initiating and cooperating. Examples of tasks included projects that the women were specifically interested in learning such as jewelry making, holiday decorations, clay work and other home décor projects. Investigators observed these and other behaviors during the group sessions, and scored individuals using the OTTOS instrument.
| Study group | Role | What they receive |
|---|---|---|
| Survivors of Sex Trafficking | Experimental | Survivors of sex trafficking (SST) who were living in a residential facility participated in this project by receiving occupation-based programming to address limitations in executive function skills over the course of the 8-month project. Sessions were held twice-monthly for an hour duration at each session. Receives: Behavioral: Occupation-based programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function Performance Test (EFPT)
The EFPT is a task-based measure where clients engage in actual functional tasks, including a simple cooking activity, use of telephone to obtain public information, organization of a medication routine, and money management. The number of cues needed to perform each task and the type of cue used is recorded. The EFPT measures the construct of executive function.
Measured: 8 months
Secondary outcomes (2)
The Canadian Occupational Performance Measure (COPM)
The COPM measures the construct of occupational performance. The tool consists of an unstructured interview whereby the rater assists the client in articulating current daily activities in the domains of self-care, work, and leisure. From this list of activities, the client rates the importance of each activity and her current satisfaction with performance on each task. A prioritized list of the five most important activities is created and associated satisfaction levels are assigned. The list can serve as a foundation for intervention planning and creation of client-centered goals.
Measured: 8 months
The Occupational Therapy Task Observation Scale (OTTOS)
The OTTOS evaluates task and general behavior. Skills subsumed under task behavior measured by the OTTOS include 1) engagement; 2)coordination, 3) follows directions, 4) quality of work, 5) independence, 6) initiative, 7) decision making, 8) concentration, 9) frustration tolerance, and 10) problem solving; skills subsumed under general behavior include 11) appearance, 12) activity level, 13) expression, 14) cooperation, and 7) socialization. Each skill is scored on a 10-point rating scale, 0 being dysfunctional, and 10 being functional. A total score for task behavior is generated (max 100) and a total score for general behavior is multiplied by 2, to also obtain a max of 100. The tool is frequently used with clients having psychiatric disorders and has shown a high correlation (0.92) between occupational therapist raters.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Sep 2016
- Primary completion31 Mar 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sex TraffickingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group, pretest-posttest design
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon W. Mangum, MPS, LOTR, Principal investigator, Louisiana State University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611998
- Sponsor's protocol ID
- LSUHSCIRB9383
- Status last verified
- Aug 2018
- First submitted
- 2 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babcock, E. (2014). Using brain science as a way out of poverty. Crittenton Women's Union. @http://s3.amazonaws.com/empath-website/pdf/Research-UsingBrainScienceDesignPathwaysPoverty-0114.pdf.
Hemmings S, Jakobowitz S, Abas M, Bick D, Howard LM, Stanley N, Zimmerman C, Oram S. Responding to the health needs of survivors of human trafficking: a systematic review. BMC Health Serv Res. 2016 Jul 29;16:320. doi: 10.1186/s12913-016-1538-8.
PubMed 27473258Newby A, McGuinness TM. Human trafficking: what psychiatric nurses should know to help children and adolescents. J Psychosoc Nurs Ment Health Serv. 2012 Apr;50(4):21-4. doi: 10.3928/02793695-20120307-03. Epub 2012 Mar 14.
PubMed 22421012Perry, B. D. (2009). Examining child maltreatment through a neurodevelopmental lens: Clinical applications of the neurosequential model of therapeutics. Journal of Loss and Trauma, 14(4), 240-255. 10.1080/15325020903004350 Retrieved from https://doi.org/10.1080/15325020903004350
Baum CM, Connor LT, Morrison T, Hahn M, Dromerick AW, Edwards DF. Reliability, validity, and clinical utility of the Executive Function Performance Test: a measure of executive function in a sample of people with stroke. Am J Occup Ther. 2008 Jul-Aug;62(4):446-55. doi: 10.5014/ajot.62.4.446.
PubMed 18712007Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990 Apr;57(2):82-7. doi: 10.1177/000841749005700207.
PubMed 10104738Margolis RL, Harrison SA, Robinson HJ, Jayaram G. Occupational therapy task observation scale (OTTOS): a rapid method for rating task group function of psychiatric patients. Am J Occup Ther. 1996 May;50(5):380-5. doi: 10.5014/ajot.50.5.380.
PubMed 8728668
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivors of Sex Trafficking: Occupation-Based Interventions for Executive Functioning
- ClinicalTrials.gov ID
- NCT03611998
- Acronym / sponsor ID
- LSUHSCIRB9383
- Conditions
- Sex Trafficking, Mental Disorder
- Keywords
- Sex trafficking, Occupational therapy, Occupation-based programming, Activity-based programming, Brain trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 2 Aug 2018 (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.
Persons traumatized through sex trafficking can demonstrate similar neurobehavioral and executive function (EF) deficits as persons with cortical injuries. In this pilot study, occupation-based activity (OBA) programming was implemented at a residence for females who had been trafficked. The study hypothesis was that OBA would facilitate development of EF skills in these clients, enabling more successful occupational performance. Method: Eight women engaged in OBA sessions over the course of eight months. Session objectives were to maximize independence in daily life skills and to foster EF component skills such as problem-solving, decision-making, cooperation, direction following and appropriate self-expression. Outcome measures used were the Executive Function Performance Test (EFPT), the Canadian Occupational Performance Measure (COPM) and the Occupational Therapy Task Observation Scale (OTTOS). Results: Gains were seen from baseline to final session in COPM score changes meeting minimally clinical difference, and OTTOS scores showing significant improvement: t(7)= -2.49, p=.04. Preliminary findings suggest that occupation-based programming may facilitate development of EF skills in sex-trafficked women.
Detailed description
Individuals who are sex-trafficked experience a combination of sexual violence, emotional trauma, and physical injuries that lead to high rates of depression, anxiety and post traumatic stress disorder (PTSD) Prolonged stress and adverse learning experiences can also cause use-dependent brain changes that influence executive functioning (EF) development. Other distressing situations, such as living in poverty or in dangerous environments and experiencing early sexual trauma, can result in interrupted development of executive functioning skills Although the current OT literature in the area of human and sex trafficking provide recommendations regarding areas of advocacy, education and occupation-based interventions, there is no empirical evidence to date investigating the efficacy of occupation-based interventions with survivors of sex trafficking (SST). The research question addressed in this pilot study was whether occupation-based interventions would improve the overall occupational performance of SST living in a residential program. Therefore, the purpose was to objectively determine the efficacy of occupation-based activity to improve EF skills in SST; the researchers expected that an improvement in EF skills would translate to improved occupational performance.
This pilot study used a one-group, pretest-posttest design. Participants in the study were residents of a local residential program for survivors of sex trafficking (SST). Eight women, average age, 20 to 50 years who were living in the home during the eight-month project period, engaged in the occupation-based intervention groups provided and completed assessment outcome measures (Canadian Occupational Performance Measure and the Executive Function Performance Test) before and after completing the program. Group behavior was scored at each session attended with the Occupational Therapy Task Observation Scale (OTTOS). Group sessions consisted of specific tasks performed to completion that emphasized problem-solving, decision-making, frustration tolerance and cooperation.
Current performance level rating and performance satisfaction scores from the COPM, as well as scores from each area of the EFPT, were collected upon initial evaluation and at the end of the eight-month intervention period. OTTOS scores were recorded during each group intervention for individual clients and graphically recorded to demonstrate individual changes over time; day one OTTOS scores were compared to the OTTOS score of the final intervention. All comparisons were completed using two-tailed, paired t-tests with a .05 alpha level for significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group, pretest-posttest design
| Arm | Type | Receives |
|---|---|---|
| Survivors of Sex Trafficking | Experimental | Behavioral: Occupation-based programmingSurvivors of sex trafficking (SST) who were living in a residential facility participated in this project by receiving occupation-based programming to address limitations in executive function skills over the course of the 8-month project. Sessions were held twice-monthly for an hour duration at each session. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant had to be a resident of the performance site and have a history of being sex-trafficked.
Key exclusion criteria (1 listed)
- Participants were not enrolled if behavioral issues prevented participation or impacted the safety of others as determined by resident directors
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 |
|---|---|---|
| Occupation-based programmingGroup sessions consisted of specific tasks performed to completion that emphasized skills such as problem-solving, decision-making, frustration tolerance, appropriate pacing, attention, inquiring, sequencing, gathering, organizing, adjusting, responding, enduring, initiating and cooperating. Examples of tasks included projects that the women were specifically interested in learning such as jewelry making, holiday decorations, clay work and other home décor projects. Investigators observed these and other behaviors during the group sessions, and scored individuals using the OTTOS instrument. | Behavioural | Survivors of Sex Trafficking |
Primary outcome
Executive Function Performance Test (EFPT)
Time frame: 8 months
The EFPT is a task-based measure where clients engage in actual functional tasks, including a simple cooking activity, use of telephone to obtain public information, organization of a medication routine, and money management. The number of cues needed to perform each task and the type of cue used is recorded. The EFPT measures the construct of executive function.
2 secondary outcomes
The Canadian Occupational Performance Measure (COPM)
Time frame: 8 months
The Occupational Therapy Task Observation Scale (OTTOS)
Time frame: 8 months
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 3 Aug 2018.
- BackgroundBabcock, E. (2014). Using brain science as a way out of poverty. Crittenton Women's Union. @http://s3.amazonaws.com/empath-website/pdf/Research-UsingBrainScienceDesignPathwaysPoverty-0114.pdf.
- Background: PubMed 27473258Hemmings S, Jakobowitz S, Abas M, Bick D, Howard LM, Stanley N, Zimmerman C, Oram S. Responding to the health needs of survivors of human trafficking: a systematic review. BMC Health Serv Res. 2016 Jul 29;16:320. doi: 10.1186/s12913-016-1538-8.
- Background: PubMed 22421012Newby A, McGuinness TM. Human trafficking: what psychiatric nurses should know to help children and adolescents. J Psychosoc Nurs Ment Health Serv. 2012 Apr;50(4):21-4. doi: 10.3928/02793695-20120307-03. Epub 2012 Mar 14.
- BackgroundPerry, B. D. (2009). Examining child maltreatment through a neurodevelopmental lens: Clinical applications of the neurosequential model of therapeutics. Journal of Loss and Trauma, 14(4), 240-255. 10.1080/15325020903004350 Retrieved from https://doi.org/10.1080/15325020903004350
- Background: PubMed 18712007Baum CM, Connor LT, Morrison T, Hahn M, Dromerick AW, Edwards DF. Reliability, validity, and clinical utility of the Executive Function Performance Test: a measure of executive function in a sample of people with stroke. Am J Occup Ther. 2008 Jul-Aug;62(4):446-55. doi: 10.5014/ajot.62.4.446.
- Background: PubMed 10104738Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990 Apr;57(2):82-7. doi: 10.1177/000841749005700207.
- Background: PubMed 8728668Margolis RL, Harrison SA, Robinson HJ, Jayaram G. Occupational therapy task observation scale (OTTOS): a rapid method for rating task group function of psychiatric patients. Am J Occup Ther. 1996 May;50(5):380-5. doi: 10.5014/ajot.50.5.380.
- Individual participant dataSharing planned: No
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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.
Shannon W. Mangum, MPS, LOTR principal investigator
Louisiana State University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupation-based programming in people with Sex Trafficking and Mental Disorder, run by Louisiana State University Health Sciences Center in New Orleans 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 1 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 3 Aug 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?
Executive Function Performance Test (EFPT) (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03611998, which also lists 7 linked publications.
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 3 Aug 2018.