Domestic Violence Discussion Session

Intimate Partner Violence Clinical Trial

Official title:

Microfinance-Discussion Session Intervention in Post-Conflict Central African States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322880
• Other study ID #: HF15660-101
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: March 24, 2011
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: February 2009
• Source: London School of Economics and Political Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Over the last twenty years micro-finance based interventions have proven to be a popular and often effective means of improving the economic outcomes of impoverished women. However, the gains to microfinance based interventions on women's decision making in both economic and non-economic arenas remains largely unknown. Specifically, the question of to what extent does access to small-scale credit alone, rather than other programs often combined with microfinance, affect women's empowerment is of particular interest when determining interventions in a variety of setting in developing nations. There exists evidence that women's empowerment is associated with reduced violence and as such maybe an important tool for improving adult women's wellbeing. In addition increased decision making power by women has been associated with improvement in children's health outcomes, especially for girls, and as such may be way generating intergenerational improvements in women's outcomes.

The goal of this project is to disentangle the effects of access to credit alone from the information on financial and personal decision making that is frequently coupled with these programs. To accomplish this, the investigators use a randomized field experiment among participants in Village Savings and Loans Associations (VSLA's). VSLA participants are a self-selected group of people who pool their money into a fund from which members can borrow. The money is paid back with interest, causing the fund to grow. The regular savings contributions to the VSLA are deposited with an end date (usually less than 1 year) after which all or part of the total funds are distributed to the individual members. The small loans are paid back with interest which is determined by the group at the time of formation and the returns from these interest payments are also distributed to the groups. The investigators then test whether there are additional gains to women's well-being by providing VSLA participants with training on process-based decision making to determine if there is a need for additional efforts to improve the decision making structure in households. To the extent that increased access to credit and more broadly financial resources is limited by existing constraints on women's decision making power, this additional training may be a necessary part of the creation of credit markets in improving the health and well-being of women and children.

Description:

• How are subjects recruited? What inducement is offered? If participants are paid, what amount and when are they paid? Is there partial pay for partial completion? (Append copy of letter or advertisement or poster, if any.)

Subjects are voluntary participants in a Village and Savings Group organized by the International Rescue Committee

• Salient characteristics of subjects--number who will participate, age range, sex, institutional affiliation, other special inclusion and exclusion criteria (if children, prisoners or other vulnerable subjects are recruited, explain why their inclusion is necessary):

Subjects will be 600 individuals, predominantly women, aged 20-50, who reside in the Burundi province of Makamba (in the southern part of Burundi)

• Describe how permission has been obtained from cooperating institution(s)--school, hospital, corporation, prison, or other relevant organization. (Append letters.) Is the approval of other research compliance committees or another Institutional Review Board required?

Jodi Nelson: (protocols)

• What do subjects do, or what is done to them, or what information is gathered? (Append copies of instructions, tests, questionnaires, or interview guides to be used.) How many times will observations, tests, etc., be conducted? How long will their participation take? Are interviews to be tape recorded or videotaped?

Everyone in the sample (N=600) is in a VSLA with its financial design previously determined. Half of the sample will be treated as the "control" group and will not receive the treatment. Of this sample, in half of the VSLA's the investigators will ask the spouse to accompany the member to one payment meeting. A baseline survey will be conducted in January 2008 to gather basic demographic information as well as pre-treatment levels of variables of interest The training/discussion groups will take place over several months are intended to promote joint decision-making. conduct a post-treatment survey to determine immediate gains from the treatment. After another 1-2 months, the investigators will conduct a final survey to determine the survival rate of any changes. Interviews will be recorded in written form to be input into computerized data management systems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participation in Village Savings and Loans Association program administered by International Rescue Committee--Burundi

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

Behavioral:
• Discussion sessions
Those selected were invited to attend a 6 session course on household decision-making with their spouses. Topics included budgeting, household financial management, and negotiation skills
• Village Savings and Loans Associations
The approach developed by CARE International develops Village Savings and Loan Associations (VSLAs). A VSLA is a self-selected group of people who pool their money into a fund from which members can borrow. The money is paid back with interest, causing the fund to grow. The regular savings contributions to the Association are deposited with an end date in mind for distribution of all or part of the total funds (including interest earnings) to the individual members, usually on the basis of a formula that links payout to the amount saved. This lump sum distribution provides a large amount of money that members can then use as they want, without restriction.

Locations

Country	Name	City	State
Burundi	International Rescue Committee--Burundi	Makamba

Sponsors (1)

Lead Sponsor	Collaborator
London School of Economics and Political Science

Country where clinical trial is conducted

Burundi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Domestic Violence Exposure	The measure of exposure to violence used in this survey is the Hurt Insult Threaten Scream (HITS) instrument. It includes four items: physical abuse, insults, threats and screaming. The four items are scored on a Likert 5-point scale. The HITS was chosen due to its proven applicability in a variety of settings , and because it allows for a rapid appraisal of past experiences of violence. Its measurement regards the two weeks prior to the interview. Similar to the more commonly used World Health Organization methodology, but includes indicators of abuse such as threats and insults.	baseline, 6 months, 12 months, 15 months	No
Secondary	Attitudes towards gender roles and rights	Attitudinal questions on traditional gender roles and appropriateness of abuse in a range of common settings. The questions are based on those asked in the Demographic Health Survey funded by USAID	Baseline, 6 months, 15 months	No
Secondary	Economic Empowerment	The intervention aimed to improve decision making dynamics in this direction, encouraging both men and women to take increasingly more decisions jointly. We identified several areas which may be critical to women's empowerment: income/asset-related decision making authority, fertility decision making authority, safety, and legal and political rights	baseline, 6 months, 12 months, 15 months	No

External Links

•   Supplementary Material for Intervention (training, survey instruments, instructions)