N/A
Completed N=238
Caregiver Training to Prevent Konzo Disease in Children in Democratic Republic of Congo (DRC)
Malnutrition · Manihot Species Poisoning
Source: ClinicalTrials.gov NCT04036708 ↗
Enrolled (actual)
238
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Mullen Scales of Early Learning (MSEL) Composite Score — 73.63; 74.33; 77.04; 76.75 t-score — p=.77
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mullen Scales of Early Learning (MSEL) Composite Score |
73.63; 74.33; 77.04; 76.75 | .77 |
| PRIMARY Child Urine Thiocyanite Level |
74.98; 139.00; 146.45; 108.91 | .01 sig |
| SECONDARY Home Observation for the Measurement of the Environment (HOME) Score |
69.37; 67.61; 71.49; 68.07 | .55 |
| SECONDARY Child Physical Growth: Length for Age Z-score |
-1.72; -1.88; -1.57; -1.96 | .32 |
| SECONDARY Child Physical Growth: Weight for Age Z-score |
-1.54; -1.92; -1.40; -2.10 | .06 |
| SECONDARY Caregiver Anxiety Symptoms |
2.86; 3.91; 2.80; 3.74 | .04 sig |
| SECONDARY Caregiver Depressive Symptoms |
2.21; 4.25; 2.45; 4.18 | <.01 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04036708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.