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

Stress Clinical Trial

— SEE-Change  

Official title:

SEE Change Evaluation - Assessing Impacts of Personal Agency Training to Advance Entrepreneurial Outcomes in Uganda

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958225
• Other study ID #: 00024029
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Anita V Shankar, PhD
• Phone: +16179556726
• Email: anita.shankar[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: September 30, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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;

Related Conditions & MeSH terms

• Financial Stress
• Stress

Intervention

Behavioral:
• SEE Change Business and Personal Agency Training
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.

Locations

Country	Name	City	State
Uganda	Innovations for Poverty Action	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Innovations for Poverty Action, Investors Club/Enterprise Uganda

Country where clinical trial is conducted

Uganda, 

References & Publications (12)

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. — View Citation

Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. Organizational research methods, 4(1), 62-83.

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

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. — View 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

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. — View 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. — View 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.

Rosenberg, M. (1965). Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package, 61(52), 18.

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. — View 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. — View 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.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, six months
Primary	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.	Baseline, six months
Primary	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	Baseline, six months
Primary	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.	Baseline, six months
Primary	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.	Baseline, six months
Primary	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	Baseline, six months
Primary	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	Baseline, six months
Secondary	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)	Baseline, six months
Secondary	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.	Baseline, six months
Secondary	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.	Baseline, six months
Secondary	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.	Baseline, six months
Secondary	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.	Baseline, six months
Secondary	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.	Baseline, six months
Secondary	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.	Baseline, six months