AzTrials
AzTrials

Well-Being, PsychologicalSEE-ChangeNCT05958225

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

A study testing SEE Change Business and Personal Agency Training in people with Well-Being, Psychological and Economic Hardship, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
SEE Change Business and Personal Agency Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
814 participants
Where
1 siteUganda
Study dates
19 Sep 2023to 30 Oct 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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • Innovations for Poverty Action

    Kampala

Other trials in Uganda

About this study

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

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).

Read the 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.

Being tested
SEE Change Business and Personal Agency Training
Keywords
Personal agency, entrepreneurship, flourishing
Medical subject headings
Psychological Well-Being, Financial Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEE Change Business and Personal Agency TrainingBehavioural

    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.

Study groups in NCT05958225
Study groupRoleWhat they receive
Personal agency, leadership and business trainingExperimentalEntrepreneurs 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.
Receives: Behavioral: SEE Change Business and Personal Agency Training
ControlNo interventionFor this study, the control participants will not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, six months

  2. 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.

    Measured: Baseline, six months

  3. 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

    Measured: Baseline, six months

  4. 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.

    Measured: Baseline, six months

  5. 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.

    Measured: Baseline, six months

  6. 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

    Measured: Baseline, six months

  7. 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

    Measured: Baseline, six months

Secondary outcomes (7)

  1. 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)

    Measured: Baseline, six months

  2. 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.

    Measured: Baseline, six months

  3. 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.

    Measured: Baseline, six months

  4. 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.

    Measured: Baseline, six months

  5. 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.

    Measured: Baseline, six months

  6. 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.

    Measured: Baseline, six months

  7. 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.

    Measured: Baseline, six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2023
  2. Study start19 Sep 2023
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
814 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05958225
Sponsor's protocol ID
IRB00024029
Acronym
SEE-Change
Status last verified
Nov 2024
First submitted
26 Jun 2023
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

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

  • 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.

    PubMed 19205937

  • 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.

    PubMed 35816496

  • 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.

    PubMed 30933213

  • 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.

    PubMed 17999228

  • 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.

    PubMed 7473027

  • 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.

    PubMed 14732414

Questions about this trial

What is this clinical trial studying?

A study testing SEE Change Business and Personal Agency Training in people with Well-Being, Psychological and Economic Hardship, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Uganda.

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 7 inclusion and 6 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 14 Nov 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 Uganda. 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?

Change in Business revenue and profits as assessed by questionnaire developed by study team (time frame: Baseline, six months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05958225, which also lists 12 linked publications.

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 14 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in