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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Wetting 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. |
| BEHAVIORAL | Mediational 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.