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

Not Applicable

Completed

Conditions: Manihot Species Poisoning
Malnutrition

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

Registration Number: NCT04036708

Lead Sponsor: Michigan State University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 238

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MISC and WTM	Wetting method (WTM)	Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
WTM only	Wetting method (WTM)	WTM trainings only (recommended standard of care) bi-weekly for 12 months.
MISC and WTM	Mediational Intervention for Sensitizing Caregivers (MISC)	Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.

Primary Outcome Measures

Name	Time	Method
Mullen Scales of Early Learning (MSEL) Composite Score	Month 6, month 12	The Mullen Scales of Early Learning (MSEL) assesses child developmental domains: visual reception, gross motor skills, fine motor skills, receptive language, and expressive language. A composite t-score derived from standardized t-scores of the four domains (excluding gross motor) provides a measure of g, the general measure of fluid intelligence thought to underlie general cognitive ability. The composite t-score ranges from 40 to 130. The t-scores have mean 100 and standard deviation 15 in the Western population. Higher scores reflect better outcome. Measure is applicable to children only, not collected from caregivers
Child Urine Thiocyanite Level	Month 6, month 12	Technicians collected samples of urine on the same day as child assessments, so that they are contiguous with level of cyanide exposure from current poorly processed cassava. Urine thiocyanite levels in urine were measured in micromol per liter. The range was 0-1032, higher scores reflect worse outcome. Data collected from children only, not collected from caregivers.

Secondary Outcome Measures

Name	Time	Method
Home Observation for the Measurement of the Environment (HOME) Score	Month 6, month 12	Home Observation for the Measurement of the Environment (HOME) composite measure designed to assess the quality and quantity of stimulation that the child is exposed to in their home environment. The Infant/Toddler version includes 45 items answered on the scale from 0=none to 3=good. A total HOME score was generated by summing item responses. Potential range is 0 to 135. Higher HOME scores indicate higher quality of home environment. Measure applies to children only.
Child Physical Growth: Length for Age Z-score	Month 6, month 12	Length for age z-score was determined using the World Health Organization algorithm using child's length, sex, and age at the time of measurement. The world population mean is 0 with standard deviation 1. Z-scores of -2 or below are often used to indicate stunting.
Caregiver Anxiety Symptoms	Month 6, month 12	The modified Hopkins Symptom Checklist was used to assess caregiver anxiety. The instrument included 9 yes/no items, and the item responses were summed into the total score. The potential range was 0-9 with higher score indicating worse anxiety. Measure applicable to caregiver only. Data were not collected from children.
Caregiver Depressive Symptoms	Month 6, month 12	The modified Hopkins Symptom Checklist was used to assess caregiver depressive symptoms. The instrument included 9 yes/no items, and the item responses were summed into the total score. The potential range was 0-9 with higher score indicating worse depressive symptoms. Measure applies to caregivers only, data were not collected from children.
Child Physical Growth: Weight for Age Z-score	Month 6, month 12	Weight for age z-score was determined using the World Health Organization algorithm using child's length, sex, and age at the time of measurement. The world population mean is 0 with standard deviation 1.