- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03611998
Survivors of Sex Trafficking: Occupation-Based Interventions for Executive Functioning
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
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New Orleans, Louisiana, United States, 70112
- Louisiana State University Health Sciences Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant had to be a resident of the performance site and have a history of being sex-trafficked.
Exclusion Criteria:
- Participants were not enrolled if behavioral issues prevented participation or impacted the safety of others as determined by resident directors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Survivors of Sex Trafficking
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Canadian Occupational Performance Measure (COPM)
Time Frame: 8 months
|
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.
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8 months
|
The Occupational Therapy Task Observation Scale (OTTOS)
Time Frame: 8 months
|
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.
|
8 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Shannon W. Mangum, MPS, LOTR, Louisiana State University Health Sciences Center
Publications and helpful links
General Publications
- Law 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.
- 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.
- Newby 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.
- Perry, 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.
- Margolis 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSUHSCIRB9383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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