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

NCT04036708 | Completed Results

• 2 other identifiers: 2272R21HD098588
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Manihot Species Poisoning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Home Observation for the Measurement of the Environment (HOME) Score

  Month 6, month 12

• Child Physical Growth: Length for Age Z-score

  Month 6, month 12

• Child Physical Growth: Weight for Age Z-score

  Month 6, month 12

• Caregiver Anxiety Symptoms

  Month 6, month 12

• Caregiver Depressive Symptoms

  Month 6, month 12

Study Arms (2)

MISC and WTM

EXPERIMENTAL

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

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

WTM only

ACTIVE COMPARATOR

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

Behavioral: Wetting method (WTM)

Interventions

Wetting method (WTM) BEHAVIORAL

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.

MISC and WTM; WTM only

Mediational Intervention for Sensitizing Caregivers (MISC) BEHAVIORAL

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).

MISC and WTM

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Institute National of Research National (INRB)

Kinshasa, Democratic Republic of the Congo

Location

Related Publications (4)

• 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.

  PMID: 23460617 BACKGROUND

• 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.

  PMID: 28807191 BACKGROUND

• 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.

  PMID: 23530166 BACKGROUND

• 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.

  PMID: 29664942 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Limitations and Caveats

The study was exploratory and developmental in nature. Where statistical significance was not reached, estimates of the means and standard deviations will be used to formally power future trials of MISC and WTM interventions.

Results Point of Contact

• Title: Michael J Boivin
• Organization: Michigan State University

boivin@msu.edu

1-517-884-0281

Study Officials

• Michael J Boivin, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Psychiatry Department Research Program

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 30, 2019
• Study Start: April 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)