ClinicalTrials.gg
CompletedNCT02415933Updated Dec 31, 2024

Child Protective Outcomes Among Ultra-poor Families in Burkina Faso

An interventional study of Trickle Up and Trickle Up Plus in Child Abuse and Child Maltreatment, sponsored by University of Chicago. Completed at 1 site in Burkina Faso. Open to participants aged 10 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by University of Chicago · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2014, registered Mar 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
720
Allocation
Randomized
Ages
10 Years to 15 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Child Abuse
  • Child Maltreatment

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
03

In context

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Households that meet the following eligibility criteria will be invited to participate in the study:

  1. Household meets locally defined poverty criteria (classified as an ultrapoor household);
  2. Mother or female caregiver of at least one child between the ages of 10 and 15.
  3. Child is between the ages of 10 and 15.
  4. Male head of household provides permission for his wife and child to participate in the study;
  5. Eligible child and female caregiver/parent can commit to study participation.

Exclusion criteria

Exclusion Criteria:

  1. Household doesn't meet locally defined poverty criteria (classified as an ultrapoor household);
  2. Mother or female caregiver doesn't have at least one child between the ages of 10 and 15.
  3. Child is not between the ages of 10 and 15.
  4. Male head of household does not provide permission for his wife and child to participate in the study;
  5. 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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
720 participants (actual)

Study arms

  • Experimental
    Trickle Up

    Economic empowerment

    Behavioral: Trickle Up

  • Experimental
    Trickle Up Plus

    Economic empowerment + child rights sensitization

    Behavioral: Trickle Up Plus

  • No intervention
    Wait-list

    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.

Interventions

  • BehavioralTrickle Up

    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.

  • BehavioralTrickle Up Plus

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 12 months, 24 months

  2. 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).

    Time frame: 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).

    Time frame: Baseline, 12 months, 24 months

Other outcomes

  1. Change in Mother's Level of Depression

    Change in mother's level of depression is assessed by Patient Health Questionnaire / PHQ-9

    Time frame: Baseline, 12 months, 24 months

  2. Change in Mother's Level of Anxiety

    Change in mother's level of anxiety is assessed by GAD-7 Anxiety

    Time frame: Baseline, 12 months, 24 months

07

Study locations

1 site
  • Trickle Up Burkina Faso
    Ouagadougou, Burkina Faso
08

References and documents

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 27764155 ↗
  • Karimli 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 29273116 ↗
  • Ismayilova 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 30110179 ↗
  • Ismayilova 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 29743136 ↗
  • Ismayilova 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 34790432 ↗
  • Karimli, 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02415933
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
First posted
Apr 14, 2015
Start date
Oct 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Dec 31, 2024

Study contacts

Leyla Ismayilova, PhD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion