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

Michigan State University

Status: Completed

Conditions: Malnutrition; Manihot Species Poisoning

Treatments: Behavioral: Wetting method (WTM); Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04036708

R21HD098588 (U.S. NIH Grant/Contract)

2272

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 patients

Sex: All

Ages: 1 to 4 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mother with at least one child aged between 1 and 4 years
• Mother is the primary caregiver of child
• Mother is 18 years of age or older

Exclusion criteria

• History of brain injury (infectious, traumatic, birth) in child
• Konzo disease in any family member of household
• Epilepsy in child
• Any neurodisability in child
• Caregiver is unable to participate in the year-long training

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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238 participants in 2 patient groups

MISC and WTM

Experimental group

Description:

Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.

Treatment:

Behavioral: Wetting method (WTM)

Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)

WTM only

Active Comparator group

Description:

WTM trainings only (recommended standard of care) bi-weekly for 12 months.

Treatment:

Behavioral: Wetting method (WTM)