Child AbuseNCT02415933
Child Protective Outcomes Among Ultra-poor Families in Burkina Faso
A study testing Trickle Up and Trickle Up Plus in people with Child Abuse and Child Maltreatment, run by University of Chicago at 1 site in Burkina Faso.
Trial summary
This study tests the effects of family-based economic empowerment intervention, alone and in combination with child rights sensitization component, on child protective outcomes among ultra-poor families in Nord Region, Burkina Faso. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Abuse, Child Maltreatment
- What is being tested?
- Trickle Up and Trickle Up Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Oct 2014to Dec 2016
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Households that meet the following eligibility criteria will be invited to participate in the study:
- Household meets locally defined poverty criteria (classified as an ultrapoor household);
- Mother or female caregiver of at least one child between the ages of 10 and 15.
- Child is between the ages of 10 and 15.
- Male head of household provides permission for his wife and child to participate in the study;
- Eligible child and female caregiver/parent can commit to study participation.
Who cannot join
- Household doesn't meet locally defined poverty criteria (classified as an ultrapoor household);
- Mother or female caregiver doesn't have at least one child between the ages of 10 and 15.
- Child is not between the ages of 10 and 15.
- Male head of household does not provide permission for his wife and child to participate in the study;
- Eligible child or mother/female caregiver cannot commit to study participation.
- Participants are also excluded from participation in the study if the child or the parent is assessed to have a cognitive impairment that would interfere with their ability to provide informed consent and participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Child Protective Effects of Economic Strengthening and Child Rights Interventions Among Ultra-poor Families in Burkina Faso
This study tests the effects of family-based economic empowerment intervention, alone and in combination with child rights sensitization component, on child protective outcomes among ultra-poor families in Nord Region, Burkina Faso.
Read the detailed description
This study evaluates a combined economic empowerment and child rights intervention to prevent violence against children and exploitation of children in ultra-poor communities in Burkina Faso. This evaluation study takes place in the Nord Region of Burkina Faso which is located in the Sahel Desert on the border to Mali. The Nord Region is characterized by extreme poverty and an ongoing food and nutrition crisis due to cyclical droughts. Extreme poverty heightens risks of violence and exploitation of children, particularly girls, who may end up in the worst forms of child labor as defined by the UN (e.g., slavery, debt bondage, forced or hazardous work in gold mines, cotton fields, or plantations in the Ivory Coast or in the South of Burkina Faso, involving physical deprivation and violence). About 1.25 million (or 37.8%) of children ages 5-14 in Burkina Faso are working to augment the incomes of their families, or because their families are too poor to support them. Adolescent girls being sent away to work as maids, facing risks of sexual exploitation and abuse. Boys being sent to religious schools madrassas, where they are made to do unpaid and/or hazardous work including begging in the street, and are subject to physical abuse.
The study employs a 3-arm cluster (group) randomized control trial design with baseline and one-year follow-up and includes 360 households (120 households per arm). Each selected household includes a female primary caregiver with a child between the ages of 10-15 who is also able to participate in the evaluation study. The study evaluates the efficacy of an economic empowerment program (Trickle Up) and a combination economic empowerment and child rights sensitization program (Trickle Up Plus) to prevent child separation and potential subsequent exposure to exploitation, abuse, and hazardous working conditions among children. Randomization occurred at the village level to assign households to three study arms: Trickle Up, Trickle Up Plus or the wait-list condition which serves as the control arm. Participants were recruited from 12 impoverished comparable villages that were selected based on socio-economic status (poverty ranking and food insecurity), geography, population size, and distance from urban center. Within these communities, families living in ultra-poverty were identified using a Participatory Wealth Ranking (PWR) exercise.
The evaluation study is implemented in partnership with the Trickle Up organization, Women's Refugee Council (WRC), and Aide aux Enfants et aux Families Démunies (ADEFAD).
- Conditions
- Child Abuse, Child Maltreatment
- Being tested
- Trickle Up, Trickle Up Plus
- Keywords
- Burkina Faso, West Africa, Children, Child Abuse, Child Mental Health, Economic Empowerment, Women's Empowerment, Domestic Violence, Child and Family Well-being, Child Separation, Child Labor, Child Maltreatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trickle UpBehavioural
Female caregivers (mothers) receive a package of interventions on economic empowerment and livelihood strengthening:
- Savings group formation and training for a group of 15-25 women which provides a place to save, take out emergency loans and builds community networks and social capital;
- Provision of seed grants to assist in business start-ups through microfinance loans;
- One-on-one mentoring and coaching on livelihood development, which is held on a bi-weekly or monthly basis;
- Trainings on financial planning and household livelihoods.
Trickle Up PlusBehavioural
In addition to the economic empowerment program for women (Trickle Up), all members of the household assigned to Trickle Up+ arm receive sensitization component on beliefs and knowledge related to protection of children from violence and exploitation. Training sessions are developed and delivered by a local organization, Aide aux Enfants et aux Familles Démunies (ADEFAD).
Sessions involve all members of the household and focus on knowledge and cultural norms associated with child protective outcomes (e.g. the dangers of child separation such as sending children away for work, the importance of education for girls, risks of child and forced marriage).
| Study group | Role | What they receive |
|---|---|---|
| Trickle Up | Experimental | Economic empowerment Receives: Behavioral: Trickle Up |
| Trickle Up Plus | Experimental | Economic empowerment + child rights sensitization Receives: Behavioral: Trickle Up Plus |
| Wait-list | No intervention | Women in villages assigned to the control arm do not receive any intervention during the study period, but are placed on a wait-list to receive the intervention upon completion of the evaluation phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Protection
Questions assess children's labor-related family separation, early and forced marriage, involvement in child labor and exposure to the Worst Forms of Child Labor (e.g. slavery, debt bondage, serfdom, transactional sex, forced or hazardous work). Questions adapted from International Labour Organization (ILO)'s Statistical Information and Monitoring Programme on Child Labour (SIMPOC) Survey.
Measured: Baseline, 12 months, 24 months
Change in Exposure to Child Abuse
Exposure to physical and emotional violence is measured using the International Society for the Prevention of Child Abuse and Neglect Screening Tool (Child Abuse Screening Tool, Children's Version / ICASTCH).
Measured: Baseline, 12 months, 24 months
Secondary outcomes (1)
Change in Child Mental Health
Child's emotional well-being and mental health problems (depression, post-traumatic symptoms and low self-esteem) are measured using Epidemiological Studies Depression Scale for Children (CES-DC), Rosenberg Self-Esteem Scale and Children's Revised Impact of Event Scale (CRIES).
Measured: Baseline, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- TrickleUp, Women's Refugee Commission, Aide aux Enfants et aux Familles Démunies (ADEFAD), Network of European Foundations (NEF), Child Protection Working Group (UNICEF), Bernard van Leer Foundation, Oak Foundation, UBS Optimus Foundation, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Leyla Ismayilova, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415933
- Sponsor's protocol ID
- IRB13-1481
- Status last verified
- Sep 2023
- First submitted
- 30 Mar 2015
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ismayilova L, Gaveras E, Blum A, To-Camier A, Nanema R. Maltreatment and Mental Health Outcomes among Ultra-Poor Children in Burkina Faso: A Latent Class Analysis. PLoS One. 2016 Oct 20;11(10):e0164790. doi: 10.1371/journal.pone.0164790. eCollection 2016.
PubMed 27764155Karimli L, Rost L, Ismayilova L. Integrating Economic Strengthening and Family Coaching to Reduce Work-Related Health Hazards Among Children of Poor Households: Burkina Faso. J Adolesc Health. 2018 Jan;62(1S):S6-S14. doi: 10.1016/j.jadohealth.2017.07.007.
PubMed 29273116Ismayilova L, Karimli L. Harsh Parenting and Violence Against Children: A Trial with Ultrapoor Families in Francophone West Africa. J Clin Child Adolesc Psychol. 2020 Jan-Feb;49(1):18-35. doi: 10.1080/15374416.2018.1485103. Epub 2018 Aug 15.
PubMed 30110179Ismayilova L, Karimli L, Sanson J, Gaveras E, Nanema R, To-Camier A, Chaffin J. Improving mental health among ultra-poor children: Two-year outcomes of a cluster-randomized trial in Burkina Faso. Soc Sci Med. 2018 Jul;208:180-189. doi: 10.1016/j.socscimed.2018.04.022. Epub 2018 May 7.
PubMed 29743136Ismayilova L, Karimli L, Gaveras E, To-Camier A, Sanson J, Chaffin J, Nanema R. An Integrated Approach to Increasing Women's Empowerment and Reducing Domestic Violence: Results of a Cluster-Randomized Controlled Trial in a West African Country. Psychol Violence. 2018 Jul;8(4):448-459. doi: 10.1037/vio0000136. Epub 2017 Aug 7.
PubMed 34790432Karimli, L., Bose, B., & Kagotho, N. (2019). Integrated Graduation Program and its Effect on Women and Household Economic Well-being: Findings from a Randomised Controlled Trial in Burkina Faso. The Journal of Development Studies, 1-18. https://doi.org/10.1080/00220388.2019.1677887
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Child Protective Effects of Economic Strengthening and Child Rights Interventions Among Ultra-poor Families in Burkina Faso
- ClinicalTrials.gov ID
- NCT02415933
- Acronym / sponsor ID
- IRB13-1481
- Conditions
- Child Abuse, Child Maltreatment
- Keywords
- Burkina Faso, West Africa, Children, Child Abuse, Child Mental Health, Economic Empowerment, Women's Empowerment, Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- TrickleUp, Women's Refugee Commission, Aide aux Enfants et aux Familles Démunies (ADEFAD), Network of European Foundations (NEF), Child Protection Working Group (UNICEF), Bernard van Leer Foundation, Oak Foundation, UBS Optimus Foundation, University of California, Los Angeles
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Apr 2015 (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.
This study tests the effects of family-based economic empowerment intervention, alone and in combination with child rights sensitization component, on child protective outcomes among ultra-poor families in Nord Region, Burkina Faso.
Detailed description
This study evaluates a combined economic empowerment and child rights intervention to prevent violence against children and exploitation of children in ultra-poor communities in Burkina Faso. This evaluation study takes place in the Nord Region of Burkina Faso which is located in the Sahel Desert on the border to Mali. The Nord Region is characterized by extreme poverty and an ongoing food and nutrition crisis due to cyclical droughts. Extreme poverty heightens risks of violence and exploitation of children, particularly girls, who may end up in the worst forms of child labor as defined by the UN (e.g., slavery, debt bondage, forced or hazardous work in gold mines, cotton fields, or plantations in the Ivory Coast or in the South of Burkina Faso, involving physical deprivation and violence). About 1.25 million (or 37.8%) of children ages 5-14 in Burkina Faso are working to augment the incomes of their families, or because their families are too poor to support them. Adolescent girls being sent away to work as maids, facing risks of sexual exploitation and abuse. Boys being sent to religious schools madrassas, where they are made to do unpaid and/or hazardous work including begging in the street, and are subject to physical abuse.
The study employs a 3-arm cluster (group) randomized control trial design with baseline and one-year follow-up and includes 360 households (120 households per arm). Each selected household includes a female primary caregiver with a child between the ages of 10-15 who is also able to participate in the evaluation study. The study evaluates the efficacy of an economic empowerment program (Trickle Up) and a combination economic empowerment and child rights sensitization program (Trickle Up Plus) to prevent child separation and potential subsequent exposure to exploitation, abuse, and hazardous working conditions among children. Randomization occurred at the village level to assign households to three study arms: Trickle Up, Trickle Up Plus or the wait-list condition which serves as the control arm. Participants were recruited from 12 impoverished comparable villages that were selected based on socio-economic status (poverty ranking and food insecurity), geography, population size, and distance from urban center. Within these communities, families living in ultra-poverty were identified using a Participatory Wealth Ranking (PWR) exercise.
The evaluation study is implemented in partnership with the Trickle Up organization, Women's Refugee Council (WRC), and Aide aux Enfants et aux Families Démunies (ADEFAD).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trickle Up | Experimental | Behavioral: Trickle UpEconomic empowerment |
| Trickle Up Plus | Experimental | Behavioral: Trickle Up PlusEconomic empowerment + child rights sensitization |
| Wait-list | No intervention | –Women in villages assigned to the control arm do not receive any intervention during the study period, but are placed on a wait-list to receive the intervention upon completion of the evaluation phase. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Households that meet the following eligibility criteria will be invited to participate in the study:
- Household meets locally defined poverty criteria (classified as an ultrapoor household);
- Mother or female caregiver of at least one child between the ages of 10 and 15.
- Child is between the ages of 10 and 15.
- Male head of household provides permission for his wife and child to participate in the study;
Key exclusion criteria (6 listed)
- Household doesn't meet locally defined poverty criteria (classified as an ultrapoor household);
- Mother or female caregiver doesn't have at least one child between the ages of 10 and 15.
- Child is not between the ages of 10 and 15.
- Male head of household does not provide permission for his wife and child to participate in the study;
- Eligible child or mother/female caregiver cannot commit to study participation.
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 |
|---|---|---|
| Trickle UpFemale caregivers (mothers) receive a package of interventions on economic empowerment and livelihood strengthening: * Savings group formation and training for a group of 15-25 women which provides a place to save, take out emergency loans and builds community networks and social capital; * Provision of seed grants to assist in business start-ups through microfinance loans; * One-on-one mentoring and coaching on livelihood development, which is held on a bi-weekly or monthly basis; * Trainings on financial planning and household livelihoods. | Behavioural | Trickle Up |
| Trickle Up PlusIn addition to the economic empowerment program for women (Trickle Up), all members of the household assigned to Trickle Up+ arm receive sensitization component on beliefs and knowledge related to protection of children from violence and exploitation. Training sessions are developed and delivered by a local organization, Aide aux Enfants et aux Familles Démunies (ADEFAD). Sessions involve all members of the household and focus on knowledge and cultural norms associated with child protective outcomes (e.g. the dangers of child separation such as sending children away for work, the importance of education for girls, risks of child and forced marriage). | Behavioural | Trickle Up Plus |
Primary outcome
Change in Child Protection
Time frame: Baseline, 12 months, 24 months
Questions assess children's labor-related family separation, early and forced marriage, involvement in child labor and exposure to the Worst Forms of Child Labor (e.g. slavery, debt bondage, serfdom, transactional sex, forced or hazardous work). Questions adapted from International Labour Organization (ILO)'s Statistical Information and Monitoring Programme on Child Labour (SIMPOC) Survey.
Change in Exposure to Child Abuse
Time frame: Baseline, 12 months, 24 months
Exposure to physical and emotional violence is measured using the International Society for the Prevention of Child Abuse and Neglect Screening Tool (Child Abuse Screening Tool, Children's Version / ICASTCH).
1 secondary outcome
Change in Child Mental Health
Time frame: Baseline, 12 months, 24 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 31 Dec 2024.
- Results publication: PubMed 27764155Ismayilova L, Gaveras E, Blum A, To-Camier A, Nanema R. Maltreatment and Mental Health Outcomes among Ultra-Poor Children in Burkina Faso: A Latent Class Analysis. PLoS One. 2016 Oct 20;11(10):e0164790. doi: 10.1371/journal.pone.0164790. eCollection 2016.
- Results publication: PubMed 29273116Karimli L, Rost L, Ismayilova L. Integrating Economic Strengthening and Family Coaching to Reduce Work-Related Health Hazards Among Children of Poor Households: Burkina Faso. J Adolesc Health. 2018 Jan;62(1S):S6-S14. doi: 10.1016/j.jadohealth.2017.07.007.
- Results publication: PubMed 30110179Ismayilova L, Karimli L. Harsh Parenting and Violence Against Children: A Trial with Ultrapoor Families in Francophone West Africa. J Clin Child Adolesc Psychol. 2020 Jan-Feb;49(1):18-35. doi: 10.1080/15374416.2018.1485103. Epub 2018 Aug 15.
- Results publication: PubMed 29743136Ismayilova L, Karimli L, Sanson J, Gaveras E, Nanema R, To-Camier A, Chaffin J. Improving mental health among ultra-poor children: Two-year outcomes of a cluster-randomized trial in Burkina Faso. Soc Sci Med. 2018 Jul;208:180-189. doi: 10.1016/j.socscimed.2018.04.022. Epub 2018 May 7.
- Results publication: PubMed 34790432Ismayilova L, Karimli L, Gaveras E, To-Camier A, Sanson J, Chaffin J, Nanema R. An Integrated Approach to Increasing Women's Empowerment and Reducing Domestic Violence: Results of a Cluster-Randomized Controlled Trial in a West African Country. Psychol Violence. 2018 Jul;8(4):448-459. doi: 10.1037/vio0000136. Epub 2017 Aug 7.
- Results publicationKarimli, L., Bose, B., & Kagotho, N. (2019). Integrated Graduation Program and its Effect on Women and Household Economic Well-being: Findings from a Randomised Controlled Trial in Burkina Faso. The Journal of Development Studies, 1-18. https://doi.org/10.1080/00220388.2019.1677887
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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.
Leyla Ismayilova, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trickle Up and Trickle Up Plus in people with Child Abuse and Child Maltreatment, run by University of Chicago at 1 site in Burkina Faso.
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 6 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 31 Dec 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 Burkina Faso. 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 Child Protection (time frame: Baseline, 12 months, 24 months). The study lists 2 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 NCT02415933, which also lists 6 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 31 Dec 2024.