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SEE Change Evaluation - Impacts of Personal Agency Training on Ugandan Entrepreneurs (SEE-Change)

Primary Purpose

Well-Being, Psychological, Economic Hardship, Stress

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
SEE Change Business and Personal Agency Training
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Well-Being, Psychological focused on measuring Personal agency, entrepreneurship, flourishing

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Small or micro entrepreneur; Business has been in operation/existence for at least the past 12 months; Entrepreneur is between the ages of 18 and 55; Entrepreneur has the ability to participate in all training activities; Informed consent is obtained from the entrepreneur; The entrepreneur is not planning to leave the area in the next 12 months; The entrepreneur has access to a phone for contact purposes; Exclusion Criteria: Entrepreneur is unable to provide informed consent or informed consent is not obtained; Entrepreneur is not considered a small or micro entrepreneur; Entrepreneur is younger than 18 years of age; Business has been in operation/existence for less than 12 months; Entrepreneur's primary business is farming (anything related to seasonal crop production); Entrepreneur is planning to leave the area in the next 12 months;

Sites / Locations

  • Innovations for Poverty ActionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Personal agency, leadership and business training

Control

Arm Description

Entrepreneurs will participate in a 3 day residential training (based on SEE Change's Empowered Entrepreneur training) that integrates personal agency with basic business and leadership topics. Participants will also get weekly support messages on their phone for 6 weeks and a check in by a training once a month for 3 months.

For this study, the control participants will not receive any intervention.

Outcomes

Primary Outcome Measures

Change in Business revenue and profits as assessed by questionnaire developed by study team
Specific questions to assess types of income generating activities and overall business growth over the past month. Questions include number of income generating activities, length of time in business, business type, days and hours worked in business, number of employees, revenues and profits earned in business. Each of these questions can be examined separately or together as a composite score based on the number of questions are combined together.
Change in Marketing score as assessed by questionnaire as assessed by the Micro-Enterprise survey
A composite score made up of a list of marketing activities that have been completed over the past three months. The score range is 0-10, with 0 being the lowest marketing activities to 10 as using all of the marketing strategies mentioned. There are 10 activities asked about (as yes/no questions) include questions to assess: negotiating with suppliers, engaging with customers to learn their needs or provide special offers, keeping supplies stocked and visiting competitors businesses.
Change in in the number of Marketing strategies adopted as assessed by questionnaire developed by study team
A composite score made up of a list of types of marketing strategies that have been completed over the past six months. The score is assess from 0-8 and includes affirmative responses. Having a score of 0 is lowest, and 8 is the highest level of marketing strategies
Change in adoption of Business skills as assessed by questionnaire developed by study team
A composite score made up of responses to a list of key business skills utilized over the past six months. These 10 questions include topics such as record keeping, keeping balance sheets, financial planning, understanding which items lead to higher profits, analysis of financial performance. Having a score of 0 is lowest, and 10 is the highest in terms of business skills.
Change in Self-efficacy as measured by the Chen scale for self efficacy
This scale asks 8 questions related to self-efficacy and each question is scored on a likert scale from 1 (Strongly disagree) to 5 (Strongly agree). The range of score are from 8-40, but usually examined as an average score (1-5), with the lowest scores being very low self-efficacy and the highest score being high self-efficacy.
Change in Self-esteem as measured by the Rosenberg scale
The Self-esteem scale is a 10 question scales that is scored on a Likert scale of 1 (strongly disagree) to 5 (strongly agree). The total score range is 10-50 and is usually examined as an average score (1-5), with the lowest scores indicating very low self-esteem and the highest score indicating very high self-esteem
Change in ability to regulate behavior as assessed by the Short Self-Regulation Questionnaire (SSRQ)
The Short Self-Regulation Questionnaire (SSRQ) is a 31-item measure of the ability to regulate behavior in order to achieve desired future outcomes. Each question is scored on a Likert scale of 1 (strongly disagree) to 5 (strongly agree), with the lowest score indicating low level of self-regulation to the highest level of self-regulation - with a range of 31-155 after adjustments for reverse scoring

Secondary Outcome Measures

Change in perseverance assessed by the Grit scale
The Grit scales includes 10 questions designed to assess level of perseverance, ability to overcome challenges and move towards one's goals. Each question is score on a Likert scale of 1 (strongly disagree) to 5 (strongly agree), with the lowest scores indicating very low grit and the highest scores indicating very high levels of grit, range (10-50)
Change in Locus of control as measured by the Internal-External Locus of Control Short Scale-4 (IE-4)
This short scale consists of 4 questions to assess how much individuals feel that have control over their lives. These questions are scored on a Likert scale from 1 (strongly disagree) to 5 (strongly agree) with the lowest scores (2) for the first two questions indicating that the individuals has a low sense of internal control over their lives, but if they score high on the first two questions (10), it indicates a high level of internal control. Similarly low scores on the remaining 2 questions indicate a low level of external control and high scores indicate a high level of external control on their lives.
Change in understanding of gender norms as assessed by the Gender norms and attitude scale
This 14 question scales is focused on understanding gender norms of the participant. Each question is scored via a Likert scale from 1 (strongly agree) to 5 (strongly disagree). Some of the questions are reverse scored, however, the scale is averaged to scores of 1-5 with the lowest scores indicating beliefs that are more in line with traditional gender norms and high scores indicating beliefs for greater equity for women, with a range of 14-70 or an average score 1-5.
Change in Depression Anxiety and Stress Scale (DASS 8)
This 8 question psychometric scale is a shortened version of the DASS 21 scale and covers questions referring to symptoms of depression, anxiety and stress. Participants are asked to rate whether they strongly agree or strongly disagree on a 6 point scale. The first 4 questions are focused on depression with a scale range of 4-24 and questions 5-8 are focused on anxiety (with a similar scale range). The lowest scores correspond to better outcomes related to depression or anxiety and the highest score correspond to worse levels of depression or anxiety.
Change in environmental mastery as assessed by the Ryff Environmental Mastery subscale
The environmental mastery scale is a subscale of the larger Ryff scales for social agency. It has 9 questions that are scored via a Likert scale of 1 (strongly disagree) and 5 (strongly agree). Some of the questions are reverse scored, but the final scores relate to high levels (5) or low levels (1) of environmental mastery.
Change in positive relations as assessed by the Ryff Positive Relations with Others subscale
The positive relations with others scale is a subscale of the larger Ryff scales for social agency. It has 9 questions that are scored via a Likert scale of 1 (strongly disagree) and 5 (strongly agree). Some of the questions are reverse scored, but the final scores relate to high levels (5) or low levels (1) of positive relationships with others.
Change in personal initiative as assessed by the Personal Initiative Scale
This 9 question scale was developed to assess level of personal initiative, drawing from their personal agency. This scales helps examine an individual's ability to be proactive and each question is scored via a Likert scale from 1 (strongly disagree) to 5 (strongly agree). An aggregate score is developed with the lowest scores indicating a low level of personal initiative and a high score as having a high level of personal initiative.

Full Information

First Posted
June 26, 2023
Last Updated
October 9, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Investors Club/Enterprise Uganda, Innovations for Poverty Action
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1. Study Identification

Unique Protocol Identification Number
NCT05958225
Brief Title
SEE Change Evaluation - Impacts of Personal Agency Training on Ugandan Entrepreneurs
Acronym
SEE-Change
Official Title
SEE Change Evaluation - Assessing Impacts of Personal Agency Training to Advance Entrepreneurial Outcomes in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Investors Club/Enterprise Uganda, Innovations for Poverty Action

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is proposed as an individually randomized control trial (RCT) designed to assess the short-term impacts (follow up at six months) of a personal agency training on a range of economic and health outcomes for micro and small entrepreneurs in Western and Central Uganda. Participants will be randomly selected and assigned to either the intervention group (n=400) or wait-listed control group (n=400). The intervention will include the standard Empowered Entrepreneur training curriculum which includes personal agency alongside basic business training that has been developed by the SEE Change team. This training will take place over three consecutive days (approximately 25 hours of content).
Detailed Description
The investigators propose to examine the comparative impacts of a personal agency and business training curricula on outcome measures focused in three areas 1) business related outcomes; 2) personal agency and flourishing; and 3) social spillover impacts. Aim 1: Assess changes in business related outcomes including improved sales and profit, enhanced business skills and behaviors, and business-related goal setting. Aim 2: Assess changes in personal agency and flourishing as determined through personal goal setting and psychometric measurements of self-esteem, self-confidence, grit and flourishing. Aim 3: Assess social spillover impacts of the training on depression, anxiety and stress, and changes in gender norms and attitudes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Well-Being, Psychological, Economic Hardship, Stress
Keywords
Personal agency, entrepreneurship, flourishing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly selected (using a stratified random sampling, stratified by gender) and assigned to either the intervention group (n=400) or wait-listed control group (n=400).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personal agency, leadership and business training
Arm Type
Experimental
Arm Description
Entrepreneurs will participate in a 3 day residential training (based on SEE Change's Empowered Entrepreneur training) that integrates personal agency with basic business and leadership topics. Participants will also get weekly support messages on their phone for 6 weeks and a check in by a training once a month for 3 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
For this study, the control participants will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
SEE Change Business and Personal Agency Training
Intervention Description
A three day residential training based on SEE Change's Empowered Entrepreneur Training curriculum. This training will be led by a certified SEE Change trained facilitator. The workshop will include individual and group exercises that allow participants to increase their self-awareness, build mental tools for resiliency and adaptability in their life, create life visions and key tools to create behavior change. Additional exercises will include specific business related content including record keeping, financial planning and marketing strategies based on the Business Model Canvas tool. After the 3 day training, the participants will receive a supportive message through an interactive voice recording, once a week for 6 weeks. In addition, they will be contacted once a month, for three months (either by phone or in person) by the trainer to see how they are doing on their goals.
Primary Outcome Measure Information:
Title
Change in Business revenue and profits as assessed by questionnaire developed by study team
Description
Specific questions to assess types of income generating activities and overall business growth over the past month. Questions include number of income generating activities, length of time in business, business type, days and hours worked in business, number of employees, revenues and profits earned in business. Each of these questions can be examined separately or together as a composite score based on the number of questions are combined together.
Time Frame
Baseline, six months
Title
Change in Marketing score as assessed by questionnaire as assessed by the Micro-Enterprise survey
Description
A composite score made up of a list of marketing activities that have been completed over the past three months. The score range is 0-10, with 0 being the lowest marketing activities to 10 as using all of the marketing strategies mentioned. There are 10 activities asked about (as yes/no questions) include questions to assess: negotiating with suppliers, engaging with customers to learn their needs or provide special offers, keeping supplies stocked and visiting competitors businesses.
Time Frame
Baseline, six months
Title
Change in in the number of Marketing strategies adopted as assessed by questionnaire developed by study team
Description
A composite score made up of a list of types of marketing strategies that have been completed over the past six months. The score is assess from 0-8 and includes affirmative responses. Having a score of 0 is lowest, and 8 is the highest level of marketing strategies
Time Frame
Baseline, six months
Title
Change in adoption of Business skills as assessed by questionnaire developed by study team
Description
A composite score made up of responses to a list of key business skills utilized over the past six months. These 10 questions include topics such as record keeping, keeping balance sheets, financial planning, understanding which items lead to higher profits, analysis of financial performance. Having a score of 0 is lowest, and 10 is the highest in terms of business skills.
Time Frame
Baseline, six months
Title
Change in Self-efficacy as measured by the Chen scale for self efficacy
Description
This scale asks 8 questions related to self-efficacy and each question is scored on a likert scale from 1 (Strongly disagree) to 5 (Strongly agree). The range of score are from 8-40, but usually examined as an average score (1-5), with the lowest scores being very low self-efficacy and the highest score being high self-efficacy.
Time Frame
Baseline, six months
Title
Change in Self-esteem as measured by the Rosenberg scale
Description
The Self-esteem scale is a 10 question scales that is scored on a Likert scale of 1 (strongly disagree) to 5 (strongly agree). The total score range is 10-50 and is usually examined as an average score (1-5), with the lowest scores indicating very low self-esteem and the highest score indicating very high self-esteem
Time Frame
Baseline, six months
Title
Change in ability to regulate behavior as assessed by the Short Self-Regulation Questionnaire (SSRQ)
Description
The Short Self-Regulation Questionnaire (SSRQ) is a 31-item measure of the ability to regulate behavior in order to achieve desired future outcomes. Each question is scored on a Likert scale of 1 (strongly disagree) to 5 (strongly agree), with the lowest score indicating low level of self-regulation to the highest level of self-regulation - with a range of 31-155 after adjustments for reverse scoring
Time Frame
Baseline, six months
Secondary Outcome Measure Information:
Title
Change in perseverance assessed by the Grit scale
Description
The Grit scales includes 10 questions designed to assess level of perseverance, ability to overcome challenges and move towards one's goals. Each question is score on a Likert scale of 1 (strongly disagree) to 5 (strongly agree), with the lowest scores indicating very low grit and the highest scores indicating very high levels of grit, range (10-50)
Time Frame
Baseline, six months
Title
Change in Locus of control as measured by the Internal-External Locus of Control Short Scale-4 (IE-4)
Description
This short scale consists of 4 questions to assess how much individuals feel that have control over their lives. These questions are scored on a Likert scale from 1 (strongly disagree) to 5 (strongly agree) with the lowest scores (2) for the first two questions indicating that the individuals has a low sense of internal control over their lives, but if they score high on the first two questions (10), it indicates a high level of internal control. Similarly low scores on the remaining 2 questions indicate a low level of external control and high scores indicate a high level of external control on their lives.
Time Frame
Baseline, six months
Title
Change in understanding of gender norms as assessed by the Gender norms and attitude scale
Description
This 14 question scales is focused on understanding gender norms of the participant. Each question is scored via a Likert scale from 1 (strongly agree) to 5 (strongly disagree). Some of the questions are reverse scored, however, the scale is averaged to scores of 1-5 with the lowest scores indicating beliefs that are more in line with traditional gender norms and high scores indicating beliefs for greater equity for women, with a range of 14-70 or an average score 1-5.
Time Frame
Baseline, six months
Title
Change in Depression Anxiety and Stress Scale (DASS 8)
Description
This 8 question psychometric scale is a shortened version of the DASS 21 scale and covers questions referring to symptoms of depression, anxiety and stress. Participants are asked to rate whether they strongly agree or strongly disagree on a 6 point scale. The first 4 questions are focused on depression with a scale range of 4-24 and questions 5-8 are focused on anxiety (with a similar scale range). The lowest scores correspond to better outcomes related to depression or anxiety and the highest score correspond to worse levels of depression or anxiety.
Time Frame
Baseline, six months
Title
Change in environmental mastery as assessed by the Ryff Environmental Mastery subscale
Description
The environmental mastery scale is a subscale of the larger Ryff scales for social agency. It has 9 questions that are scored via a Likert scale of 1 (strongly disagree) and 5 (strongly agree). Some of the questions are reverse scored, but the final scores relate to high levels (5) or low levels (1) of environmental mastery.
Time Frame
Baseline, six months
Title
Change in positive relations as assessed by the Ryff Positive Relations with Others subscale
Description
The positive relations with others scale is a subscale of the larger Ryff scales for social agency. It has 9 questions that are scored via a Likert scale of 1 (strongly disagree) and 5 (strongly agree). Some of the questions are reverse scored, but the final scores relate to high levels (5) or low levels (1) of positive relationships with others.
Time Frame
Baseline, six months
Title
Change in personal initiative as assessed by the Personal Initiative Scale
Description
This 9 question scale was developed to assess level of personal initiative, drawing from their personal agency. This scales helps examine an individual's ability to be proactive and each question is scored via a Likert scale from 1 (strongly disagree) to 5 (strongly agree). An aggregate score is developed with the lowest scores indicating a low level of personal initiative and a high score as having a high level of personal initiative.
Time Frame
Baseline, six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Small or micro entrepreneur; Business has been in operation/existence for at least the past 12 months; Entrepreneur is between the ages of 18 and 55; Entrepreneur has the ability to participate in all training activities; Informed consent is obtained from the entrepreneur; The entrepreneur is not planning to leave the area in the next 12 months; The entrepreneur has access to a phone for contact purposes; Exclusion Criteria: Entrepreneur is unable to provide informed consent or informed consent is not obtained; Entrepreneur is not considered a small or micro entrepreneur; Entrepreneur is younger than 18 years of age; Business has been in operation/existence for less than 12 months; Entrepreneur's primary business is farming (anything related to seasonal crop production); Entrepreneur is planning to leave the area in the next 12 months;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anita V Shankar, PhD
Phone
+16179556726
Email
anita.shankar@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Fritz, MPH
Phone
+17172531648
Email
hannah.marker@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita V Shankar, PhD
Organizational Affiliation
Associate Scientist, Johns Hopkins School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovations for Poverty Action
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Furaha Abwe, PhD
Phone
+255784210415
Email
fabwe@poverty-action.org
First Name & Middle Initial & Last Name & Degree
Kepher Tugezeku
Phone
+256-414-669-840
Email
ktugezeku@poverty-action.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
de Mel, Suresh and McKenzie, David John and Woodruff, Christopher, Business Training and Female Enterprise Start-Up, Growth, and Dynamics: Experimental Evidence from Sri Lanka (July 1, 2012). World Bank Policy Research Working Paper No. 6145
Results Reference
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Citation
Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. Organizational research methods, 4(1), 62-83.
Results Reference
background
PubMed Identifier
19205937
Citation
Duckworth AL, Quinn PD. Development and validation of the short grit scale (grit-s). J Pers Assess. 2009 Mar;91(2):166-74. doi: 10.1080/00223890802634290.
Results Reference
background
Citation
Robins, R. W., Hendin, H. M., & Trzesniewski, K. H. (2001). Measuring global self-esteem: Construct validation of a single-item measure and the Rosenberg Self-Esteem Scale. Personality and social psychology bulletin, 27(2), 151-161.
Results Reference
background
Citation
Rosenberg, M. (1965). Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package, 61(52), 18.
Results Reference
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Citation
Kovaleva, A., Beierlein, C., Kemper, C. J., & Rammstedt, B. (2014). Internale-Externale-Kontrollüberzeugung-4 (IE-4). Zusammenstellung sozialwissenschaftlicher Items und Skalen (ZIS). https://doi.org/10.6102/zis184
Results Reference
background
PubMed Identifier
35816496
Citation
Niessen D, Schmidt I, Groskurth K, Rammstedt B, Lechner CM. The Internal-External Locus of Control Short Scale-4 (IE-4): A comprehensive validation of the English-language adaptation. PLoS One. 2022 Jul 11;17(7):e0271289. doi: 10.1371/journal.pone.0271289. eCollection 2022.
Results Reference
background
Citation
Waszak, C, JL Severy, L Kafafi, and I Badawi. 2000. Fertility behavior and psychological stress: The mediating influence of gender norm beliefs among Egyptian women. Psychology of Women Quarterly 25:197-208.
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PubMed Identifier
30933213
Citation
VanderWeele TJ, McNeely E, Koh HK. Reimagining Health-Flourishing. JAMA. 2019 May 7;321(17):1667-1668. doi: 10.1001/jama.2019.3035. No abstract available.
Results Reference
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PubMed Identifier
17999228
Citation
Norton PJ. Depression Anxiety and Stress Scales (DASS-21): psychometric analysis across four racial groups. Anxiety Stress Coping. 2007 Sep;20(3):253-65. doi: 10.1080/10615800701309279.
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7473027
Citation
Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719.
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Citation
Carey KB, Neal DJ, Collins SE. A psychometric analysis of the self-regulation questionnaire. Addict Behav. 2004 Feb;29(2):253-60. doi: 10.1016/j.addbeh.2003.08.001.
Results Reference
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SEE Change Evaluation - Impacts of Personal Agency Training on Ugandan Entrepreneurs

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