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)

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Manihot Species Poisoning
• Intervention / Treatment: Behavioral: Wetting method (WTM); Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)

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.

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael J Boivin, PhD; Phone Number: (517) 884-0281; Email: boivin@msu.edu
• Study Contact Backup: Name: Itziar Familiar-Lopez, PhD; Phone Number: (517) 884-2906; Email: familiar@msu.edu

Study Locations

• Congo, The Democratic Republic of the
  • Kinshasa, Congo, The Democratic Republic of the
    • Institute National of Research National (INRB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MISC and WTM; Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.	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).
Active Comparator: WTM only; WTM trainings only (recommended standard of care) bi-weekly for 12 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mullen Scales of Early Learning (MSEL) Composite Score	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	Month 6, month 12
Child Urine Thiocyanite Level	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.	Month 6, month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Observation for the Measurement of the Environment (HOME) Score	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.	Month 6, month 12
Child Physical Growth: Length for Age Z-score	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.	Month 6, month 12
Child Physical Growth: Weight for Age Z-score	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.	Month 6, month 12
Caregiver Anxiety Symptoms	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.	Month 6, month 12
Caregiver Depressive Symptoms	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.	Month 6, month 12

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
• Investigators: Principal Investigator: Michael J Boivin, PhD, Professor

Publications and helpful links

General Publications

• Tshala-Katumbay D, Mumba N, Okitundu L, Kazadi K, Banea M, Tylleskar T, Boivin M, Muyembe-Tamfum JJ. Cassava food toxins, konzo disease, and neurodegeneration in sub-Sahara Africans. Neurology. 2013 Mar 5;80(10):949-51. doi: 10.1212/WNL.0b013e3182840b81.
• Boivin MJ, Okitundu D, Makila-Mabe B, Sombo MT, Mumba D, Sikorskii A, Mayambu B, Tshala-Katumbay D. Cognitive and motor performance in Congolese children with konzo during 4 years of follow-up: a longitudinal analysis. Lancet Glob Health. 2017 Sep;5(9):e936-e947. doi: 10.1016/S2214-109X(17)30267-X.
• Boivin MJ, Okitundu D, Makila-Mabe Bumoko G, Sombo MT, Mumba D, Tylleskar T, Page CF, Tamfum Muyembe JJ, Tshala-Katumbay D. Neuropsychological effects of konzo: a neuromotor disease associated with poorly processed cassava. Pediatrics. 2013 Apr;131(4):e1231-9. doi: 10.1542/peds.2012-3011. Epub 2013 Mar 25.
• Kashala-Abotnes E, Sombo MT, Okitundu DL, Kunyu M, Bumoko Makila-Mabe G, Tylleskar T, Sikorskii A, Banea JP, Mumba Ngoyi D, Tshala-Katumbay D, Boivin MJ. Dietary cyanogen exposure and early child neurodevelopment: An observational study from the Democratic Republic of Congo. PLoS One. 2018 Apr 17;13(4):e0193261. doi: 10.1371/journal.pone.0193261. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Nutrition Disorders; Poisoning; Malnutrition
• Other Study ID Numbers: 2272; R21HD098588 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study coordinator assigns a unique identification number to each research subject at entry into the study. The first page of the risk-factor questionnaire, which contains identifying information, names and addresses, is removed after data entry and stored at the field office in a locked file dedicated to this research study. The data files will include only study numbers, which are linked through a security system to a named file maintained for the purpose of informing individuals of information pertinent to their health. The name file is only accessible to the PI Professor Michael Boivin.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No