Viewing Study NCT03611998



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Last Modification Date: 2024-10-26 @ 12:50 PM
Study NCT ID: NCT03611998
Status: COMPLETED
Last Update Posted: 2018-08-03
First Post: 2018-07-02

Brief Title: Survivors of Sex Trafficking Occupation-Based Interventions for Executive Functioning
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Organization: Louisiana State University Health Sciences Center in New Orleans

Study Overview

Official Title: Survivors of Sex Trafficking Occupation-Based Interventions for Executive Functioning
Status: COMPLETED
Status Verified Date: 2018-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 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 t7 -249 p04 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None