Mental Disorder Clinical Trial
Official title:
Survivors of Sex Trafficking: Occupation-Based Interventions for Executive Functioning
Verified date | August 2018 |
Source | Louisiana State University Health Sciences Center in New Orleans |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | April 30, 2017 |
Est. primary completion date | March 31, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Louisiana State University Health Sciences Center | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Louisiana State University Health Sciences Center in New Orleans |
United States,
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.
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 8 months | |
Secondary | 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. | 8 months | |
Secondary | 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. | 8 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06102850 -
Adaptation of Critical Time Intervention for Young Adults With MH Challenges
|
N/A | |
Completed |
NCT05649449 -
Testing Self-Directed Care in Florida
|
N/A | |
Not yet recruiting |
NCT05886595 -
Being Young : My Mental Health
|
||
Recruiting |
NCT04157062 -
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
|
N/A | |
Completed |
NCT04505540 -
Start Treatment and Recovery for Opioid Use Disorder
|
N/A | |
Withdrawn |
NCT03236766 -
Engaging Pacific Islander Perspectives on Mental Illness and Mental Health Services
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Not yet recruiting |
NCT04071145 -
Using Sensors to Measure Drug Concentrations in Exhaled Breath
|
||
Completed |
NCT04457635 -
Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.
|
N/A | |
Completed |
NCT01922258 -
Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
|
Phase 3 | |
Recruiting |
NCT06054061 -
Evaluation the Efficacy "Think and Cope Positively" Program
|
N/A | |
Completed |
NCT03118388 -
Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs
|
Phase 2 | |
Active, not recruiting |
NCT04196881 -
Effect of Attention Deficit Hyperactivity Disorder Knowledge Improvement Program on Male Primary School Teachers
|
N/A | |
Terminated |
NCT04028609 -
Community Health Worker Intervention to Improve Post-Hospital Outcomes
|
N/A | |
Active, not recruiting |
NCT03641664 -
FCT Study: Reducing the Need for Out-of-Home Placements
|
N/A | |
Completed |
NCT05019937 -
Exploring Effectiveness and Mechanism of Change of an Implementation Strategy on Guideline Implementation in Schools
|
N/A | |
Active, not recruiting |
NCT04148508 -
App-based Mental Health Promotion in Young European Adults
|
N/A | |
Completed |
NCT03704805 -
Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe
|
N/A | |
Recruiting |
NCT05087446 -
Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care
|
N/A | |
Recruiting |
NCT03729050 -
Rehabilitation Coordinators in Specialist Psychiatry
|
N/A |