- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05958225
SEE Change Evaluation - Impacts of Personal Agency Training on Ugandan Entrepreneurs (SEE-Change)
SEE Change Evaluation - Assessing Impacts of Personal Agency Training to Advance Entrepreneurial Outcomes in Uganda
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kampala, Uganda
- Innovations for Poverty Action
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Personal agency, leadership and business training
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.
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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. |
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No Intervention: Control
For this study, the control participants will not receive any intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Business revenue and profits as assessed by questionnaire developed by study team
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Change in Marketing score as assessed by questionnaire as assessed by the Micro-Enterprise survey
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Change in in the number of Marketing strategies adopted as assessed by questionnaire developed by study team
Time Frame: Baseline, six months
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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
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Baseline, six months
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Change in adoption of Business skills as assessed by questionnaire developed by study team
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Change in Self-efficacy as measured by the Chen scale for self efficacy
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Change in Self-esteem as measured by the Rosenberg scale
Time Frame: Baseline, six months
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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
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Baseline, six months
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Change in ability to regulate behavior as assessed by the Short Self-Regulation Questionnaire (SSRQ)
Time Frame: Baseline, six months
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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
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Baseline, six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in perseverance assessed by the Grit scale
Time Frame: Baseline, six months
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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)
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Baseline, six months
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Change in Locus of control as measured by the Internal-External Locus of Control Short Scale-4 (IE-4)
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Change in understanding of gender norms as assessed by the Gender norms and attitude scale
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Change in Depression Anxiety and Stress Scale (DASS 8)
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Change in environmental mastery as assessed by the Ryff Environmental Mastery subscale
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Change in positive relations as assessed by the Ryff Positive Relations with Others subscale
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Change in personal initiative as assessed by the Personal Initiative Scale
Time Frame: Baseline, six months
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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.
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Baseline, six months
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Collaborators and Investigators
Investigators
- Principal Investigator: Anita V Shankar, PhD, Associate Scientist, Johns Hopkins School of Public Health
Publications and helpful links
General Publications
- Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. Organizational research methods, 4(1), 62-83.
- 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.
- 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.
- 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.
- 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
- 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.
- Rosenberg, M. (1965). Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package, 61(52), 18.
- 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
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00024029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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