Intimate Partner ViolenceNCT01322880
Domestic Violence Discussion Session
A study testing Discussion sessions and Village Savings and Loans Associations in people with Intimate Partner Violence, run by London School of Economics and Political Science at 1 site in Burundi.
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… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Discussion sessions and Village Savings and Loans Associations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 1 siteBurundi
- Study dates
- Jan 2008to Apr 2009
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participation in Village Savings and Loans Association program administered by International Rescue Committee--Burundi
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Burundi1 site
International Rescue Committee--Burundi
Makamba, Makamba Province
About this study
Official title: Microfinance-Discussion Session Intervention in Post-Conflict Central African States
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.
Read the detailed 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.
- Conditions
- Intimate Partner Violence
- Being tested
- Discussion sessions, Village Savings and Loans Associations
- Keywords
- domestic violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discussion sessionsBehavioural
Also called Household Financial Training
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 AssociationsBehavioural
Also called Village Microfinance
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Other | The project, administered by the International Rescue Committee (IRC), involved 25 village savings and loans association (VSLA) groups across the province. The VSLA groups initially formed through local members of the community designated as community based facilitators (CBF). Receives: Behavioral: Village Savings and Loans Associations |
| Treatment Group | Experimental | Half of the VSLA participants were invited to participate in an additional set of discussion groups to be attended along with their spouse. All participants were informed that due to space constraints, only half of the members would be able to attend. In each VSLA, individuals drew numbers from a bag or hat, and those with "winning" slips were the ones who entered the discussion groups with spouses. Receives: Behavioral: Discussion sessions; Behavioral: Village Savings and Loans Associations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 months, 12 months, 15 months
Secondary outcomes (2)
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
Measured: Baseline, 6 months, 15 months
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
Measured: baseline, 6 months, 12 months, 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startJan 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Investigators
- Radha Iyengar, PhD, Principal investigator, London School of Economics and Political Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322880
- Sponsor's protocol ID
- HF15660-101
- Status last verified
- Feb 2009
- First submitted
- 24 Mar 2011
- Last updated
- 25 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfinance-Discussion Session Intervention in Post-Conflict Central African States
- ClinicalTrials.gov ID
- NCT01322880
- Acronym / sponsor ID
- HF15660-101
- Conditions
- Intimate Partner Violence
- Keywords
- domestic violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Other | Behavioral: Village Savings and Loans AssociationsThe project, administered by the International Rescue Committee (IRC), involved 25 village savings and loans association (VSLA) groups across the province. The VSLA groups initially formed through local members of the community designated as community based facilitators (CBF). |
| Treatment Group | Experimental | Behavioral: Discussion sessions, Behavioral: Village Savings and Loans AssociationsHalf of the VSLA participants were invited to participate in an additional set of discussion groups to be attended along with their spouse. All participants were informed that due to space constraints, only half of the members would be able to attend. In each VSLA, individuals drew numbers from a bag or hat, and those with "winning" slips were the ones who entered the discussion groups with spouses. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in Village Savings and Loans Association program administered by International Rescue Committee--Burundi
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discussion sessionsAlso: Household Financial TrainingThose 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 | Behavioural | Treatment Group |
| Village Savings and Loans AssociationsAlso: Village MicrofinanceThe 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. | Behavioural | Control Arm, Treatment Group |
Primary outcome
Domestic Violence Exposure
Time frame: baseline, 6 months, 12 months, 15 months
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.
2 secondary outcomes
Attitudes towards gender roles and rights
Time frame: Baseline, 6 months, 15 months
Economic Empowerment
Time frame: baseline, 6 months, 12 months, 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2011.
- Supplementary Material for Intervention (training, survey instruments, instructions)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radha Iyengar, PhD principal investigator
London School of Economics and Political Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion sessions and Village Savings and Loans Associations in people with Intimate Partner Violence, run by London School of Economics and Political Science at 1 site in Burundi.
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 1 inclusion and 0 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 25 Mar 2011. 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 Burundi. 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?
Domestic Violence Exposure (time frame: baseline, 6 months, 12 months, 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2011.