NCT05958225

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
814

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 19, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

June 26, 2023

Last Update Submit

November 13, 2024

Conditions

Keywords

Personal agencyentrepreneurshipflourishing

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (7)

  • Change in perseverance assessed by the Grit scale

    Baseline, six months

  • Change in Locus of control as measured by the Internal-External Locus of Control Short Scale-4 (IE-4)

    Baseline, six months

  • Change in understanding of gender norms as assessed by the Gender norms and attitude scale

    Baseline, six months

  • Change in Depression Anxiety and Stress Scale (DASS 8)

    Baseline, six months

  • Change in environmental mastery as assessed by the Ryff Environmental Mastery subscale

    Baseline, six months

  • +2 more secondary outcomes

Study Arms (2)

Personal agency, leadership and business training

EXPERIMENTAL

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.

Behavioral: SEE Change Business and Personal Agency Training

Control

NO INTERVENTION

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

Interventions

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.

Personal agency, leadership and business training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action

Kampala, Uganda

Location

Related Publications (12)

  • 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

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

    BACKGROUND
  • 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.

    PMID: 19205937BACKGROUND
  • 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.

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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 35816496BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 30933213BACKGROUND
  • 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.

    PMID: 17999228BACKGROUND
  • 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.

    PMID: 7473027BACKGROUND
  • 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.

    PMID: 14732414BACKGROUND

MeSH Terms

Conditions

Psychological Well-BeingFinancial Stress

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorStress, PsychologicalBehavioral Symptoms

Study Officials

  • Anita V Shankar, PhD

    Associate Scientist, Johns Hopkins School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 24, 2023

Study Start

September 19, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations