NCT03611998

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: t(7)= -2.49, p=.04. Preliminary findings suggest that occupation-based programming may facilitate development of EF skills in sex-trafficked women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

July 2, 2018

Last Update Submit

August 1, 2018

Conditions

Keywords

Sex traffickingOccupational therapyOccupation-based programmingActivity-based programmingBrain trauma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The Canadian Occupational Performance Measure (COPM)

    8 months

  • The Occupational Therapy Task Observation Scale (OTTOS)

    8 months

Study Arms (1)

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.

Behavioral: Occupation-based programming

Interventions

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.

Survivors of Sex Trafficking

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsProject performance site was a residential facility for women who were sex-trafficked; Typically women are the gender involved in this activity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant had to be a resident of the performance site and have a history of being sex-trafficked.

You may not qualify if:

  • Participants were not enrolled if behavioral issues prevented participation or impacted the safety of others as determined by resident directors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (7)

  • 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.

    BACKGROUND
  • 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.

    PMID: 27473258BACKGROUND
  • 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.

    PMID: 22421012BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 18712007BACKGROUND
  • 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.

    PMID: 10104738BACKGROUND
  • 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.

    PMID: 8728668BACKGROUND

MeSH Terms

Conditions

Mental DisordersBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Shannon W. Mangum, MPS, LOTR

    Louisiana State University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One group, pretest-posttest design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2018

First Posted

August 2, 2018

Study Start

September 1, 2016

Primary Completion

March 31, 2017

Study Completion

April 30, 2017

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations