Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04518397 |
Other study ID # |
The Sankofa Paradigm |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 30, 2020 |
Est. completion date |
May 10, 2024 |
Study information
Verified date |
May 2023 |
Source |
Indiana University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to test the impact of a 6-week theatre intervention rooted in
African culture (Sankofa) on the wellness of girls (predominately African American) ages 8-18
receiving services at five Boys & Girls Club Indianapolis sites. Theatre interventions are
led by Asante theatre personnel and evaluated by the PI and occupational therapy graduate
students. The theatre intervention being evaluated has been conducted for decades by an
established theatre company with widespread community participation and anecdotal positive
responses, but has not been scientifically evaluated to understand how it impacts wellbeing.
This will be the first large-scale study of the mechanisms of change and of the impact of the
theatre intervention in the community and will help to guide future therapeutic interventions
using theatre with underserved populations.
Research questions include: Is Sankofa a feasible and acceptable intervention for the target
population? Does participation in Sankofa result in improved scores on wellness outcome
measures, including the National Youth Outcomes Initiative (NYOI) survey?
The study is funded by Asante Children's Theatre via the Central Indiana Community Foundation
Women's Fund.
Description:
This project will take place over a 3 year period and will consist of 10 6-week theatre
interventions (5 for girls 8-12 and 5 for girls 13-18). The first two (pilot) interventions
(one for each age group) are scheduled to take place in Spring of 2020. From Fall 2020
through Spring 2022, one intervention per age group will be implemented each fall and one per
age group each spring.
The theatre intervention is an Asante Theatre production that involves reading a script,
being assigned a role, rehearsing, participating in discussions about the script that will
contribute to script development/editing to personalize it, and eventually performing the
play in front of a community audience. The play is free and open to the public and at the end
of the performance participants will participate in a community conversation during which
audience members can ask questions about the process. The talk back is moderated by the PI,
and participants are not required to respond to questions but can speak up if/when they feel
comfortable doing so. Theatre interventions are led by Asante theatre personnel and evaluated
by the PI and occupational therapy graduate students. Evaluations take place after the PI
obtains parental/guardian informed consent, the week after the intervention, 6 weeks follow
up, and 6 months follow up. Evaluation sessions are conducted individually with each girl who
signs up to participate, using data collection tools described below and attached in the
'notes/attachment' section, and will take no longer than 60 minutes. Adult audience members
at performances are also participants of this study if they consent by checking "Yes" or "No"
on the Audience Survey and responding to questions. The audience survey is described briefly
below and attached in the notes/attachments section.
For 4 weeks leading up to each intervention, recruit will take place through posting flyers
throughout the Boys & Girls Club of Indianapolis (BGCI) where the interventions are to take
place (implemented at 5 different clubs throughout the city). Flyers will also be circulated
through BGCI social media and listservs, and sent home to parents. Girls who want to
participate can let BGCI staff members know and BGCI staff will provide that girl's
parent/guardian with an informed consent document to review and sign with the PI's contact
information on it in case the parent/guardian has questions. The PI will call parents to
ensure understanding and answer questions. She will also review the document to obtain assent
from girls who want to participate and have their parents' signed consent forms.