Adolescent BehaviorNCT04518397
Sankofa Paradigm: A Therapeutic Theatre Program for Girls
A study testing Theatre in people with Adolescent Behavior and Child Behavior, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years, women only
- Conditions the study is for
- Adolescent Behavior, Child Behavior, Mental Health Wellness 1
- What is being tested?
- Theatre
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female identifying
- Member of Boys and Girls Club of Indianapolis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Finish Line Boys and Girls Club
Indianapolis, Indiana, 46226
About this study
Official title: Sankofa Paradigm: A Healing-centered, Therapeutic Theatre Program for Girls Ages 7 -18
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.
Read the detailed 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.
- Being tested
- Theatre
- Medical subject headings
- Adolescent Behavior, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheatreBehavioural
6-week participatory arts culturally-informed theatre program
| Study group | Role | What they receive |
|---|---|---|
| Theatre participants | Experimental | Girls in this arm will participate in the theatre intervention. Receives: Behavioral: Theatre |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Youth Outcomes Initiative
change in leadership, competence, and social and emotional development; 45 Likert-type items; 43 scored 1-4 scale, 2 items scored on 1-5 scale, higher scores indicate better outcomes. Max score of 182.
Measured: baseline, 6-weeks, compared to national average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start30 Jan 2020
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre/post cohort
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Boys & Girls Clubs of Indianapolis, Community Health Network
- Responsible party
- Principal investigator, Sally Wasmuth, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518397
- Sponsor's protocol ID
- The Sankofa Paradigm
- Status last verified
- May 2023
- First submitted
- 14 Aug 2020
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sankofa Paradigm: A Healing-centered, Therapeutic Theatre Program for Girls Ages 7 -18
- ClinicalTrials.gov ID
- NCT04518397
- Acronym / sponsor ID
- The Sankofa Paradigm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Boys & Girls Clubs of Indianapolis, Community Health Network
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/post cohort
| Arm | Type | Receives |
|---|---|---|
| Theatre participants | Experimental | Behavioral: TheatreGirls in this arm will participate in the theatre intervention. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Female identifying
- Member of Boys and Girls Club of Indianapolis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theatre6-week participatory arts culturally-informed theatre program | Behavioural | Theatre participants |
Primary outcome
National Youth Outcomes Initiative
Time frame: baseline, 6-weeks, compared to national average
change in leadership, competence, and social and emotional development; 45 Likert-type items; 43 scored 1-4 scale, 2 items scored on 1-5 scale, higher scores indicate better outcomes. Max score of 182.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theatre in people with Adolescent Behavior and Child Behavior, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Youth Outcomes Initiative (time frame: baseline, 6-weeks, compared to national average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.