Clinical Trials Directory

Trials / Completed

CompletedNCT04036708

Caregiver Training to Prevent Konzo Disease in Children in Democratic Republic of Congo (DRC)

Caregiver Early Child Development Training for Preventing Konzo From Toxic Cassava in the Democratic Republic of Congo (DRC)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
238 (actual)
Sponsor
Michigan State University · Academic / Other
Sex
All
Age
1 Year – 4 Years
Healthy volunteers
Accepted

Summary

The proposed research adapted the caregiver training and child neurodevelopmental assessment capacity that the PI previously built in Uganda beginning in 2008, to a community-based intervention model for the prevention of konzo in the Democratic Republic of Congo.

Detailed description

Early childhood (1 through 4 yrs) is a period of dramatic developmental change that can be seriously compromised by exposure to toxic cyanogenic cassava (konzo disease), with potentially great impact throughout central and western sub-Sahara Africa in regions dependent on this food staple. In the face of ongoing economic instability and nutritional, medical and educational deprivation affecting konzo at-risk communities in the Democratic Republic of Congo, no programs exist for sustaining a favorable developmental milieu for these children. By establishing the viability of caregiver training interventions to enhance functionality among caregivers and improve caregiving quality while preventing konzo, this research l can benefit tens of millions of children at-risk neurodevelopmentally; not only from poorly processed cyanogenic cassava, but also from a myriad of other non-infectious and infectious diseases.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWetting method (WTM)The wetting method is an evidence-based, simple process to remove cyanogens from cassava flour. It involves teaching women to add water to cassava flour and allow it to stand for 2 h in the sun or 5 h in the shade for the hydrogen cyanide gas to escape. Colorfully illustrated and durable laminated posters depicting the WTM were distributed to participating households. Women received this training bi-weekly for 12 months.
BEHAVIORALMediational Intervention for Sensitizing Caregivers (MISC)The study team used MISC to train DRC mothers in practical day-to-day activities with their children to enhance 5 key mediational processes: 1) focusing (getting the child's attention and engaging directing them to learning experiences); 2) exciting (communicating excitement, appreciation, and affection with the learning experience); 3) expanding (making the child aware of how the learning experience transcends the present situation and can include past and future issues beyond the immediate need of the moment); 4) encouraging (emotional support to foster the child's sense of security and competence); and 5) regulating (helping to direct the child's behavior in constructive ways with a goal towards self-regulation).

Timeline

Start date
2021-04-01
Primary completion
2022-08-31
Completion
2022-08-31
First posted
2019-07-30
Last updated
2024-04-24
Results posted
2024-04-24

Locations

1 site across 1 country: Democratic Republic of the Congo

Source: ClinicalTrials.gov record NCT04036708. Inclusion in this directory is not an endorsement.