Trial Outcomes & Findings for Caregiver Training to Prevent Konzo Disease in Children in Democratic Republic of Congo (DRC) (NCT NCT04036708)
NCT ID: NCT04036708
Last Updated: 2024-04-24
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
238 participants
Primary outcome timeframe
Month 6, month 12
Results posted on
2024-04-24
Participant Flow
Participant milestones
| Measure |
MISC and WTM, Children
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
MISC and WTM, Caregivers
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Caregivers
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
79
|
40
|
79
|
40
|
|
Overall Study
COMPLETED
|
65
|
36
|
65
|
36
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
14
|
4
|
Reasons for withdrawal
| Measure |
MISC and WTM, Children
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
MISC and WTM, Caregivers
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Caregivers
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
4
|
14
|
4
|
Baseline Characteristics
This measure is applicable to children only. Data were not collected from caregivers.
Baseline characteristics by cohort
| Measure |
MISC and WTM, Children
n=79 Participants
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
n=40 Participants
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
MISC and WTM, Caregivers
n=79 Participants
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Caregivers
n=40 Participants
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
2.38 years
STANDARD_DEVIATION 0.68 • n=79 Participants
|
2.34 years
STANDARD_DEVIATION 0.74 • n=40 Participants
|
28.46 years
STANDARD_DEVIATION 8.37 • n=79 Participants
|
27.98 years
STANDARD_DEVIATION 9.05 • n=40 Participants
|
15.44 years
STANDARD_DEVIATION 4.71 • n=238 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=79 Participants
|
23 Participants
n=40 Participants
|
79 Participants
n=79 Participants
|
40 Participants
n=40 Participants
|
189 Participants
n=238 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=79 Participants
|
17 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
49 Participants
n=238 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=238 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=238 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=238 Participants
|
|
Race (NIH/OMB)
Black or African American
|
79 Participants
n=79 Participants
|
40 Participants
n=40 Participants
|
79 Participants
n=79 Participants
|
40 Participants
n=40 Participants
|
238 Participants
n=238 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=238 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=238 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=238 Participants
|
|
Child Mullen Scales Learning Composite
|
73.13 t-score
STANDARD_DEVIATION 12.09 • n=79 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
74.41 t-score
STANDARD_DEVIATION 11.13 • n=40 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
—
|
—
|
73.56 t-score
STANDARD_DEVIATION 11.74 • n=119 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
|
HOME score quality caregiving
|
64.88 score on a scale
STANDARD_DEVIATION 18.01 • n=79 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
69.30 score on a scale
STANDARD_DEVIATION 14.59 • n=40 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
—
|
—
|
66.36 score on a scale
STANDARD_DEVIATION 16.99 • n=119 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
|
Child Length for age z-score
|
-1.44 Z-score
STANDARD_DEVIATION 1.53 • n=79 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
-1.79 Z-score
STANDARD_DEVIATION 1.34 • n=40 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
—
|
—
|
-1.56 Z-score
STANDARD_DEVIATION 1.47 • n=119 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
|
Child weight-for-age z-score
|
-0.80 Z-score
STANDARD_DEVIATION 1.14 • n=79 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
-1.23 Z-score
STANDARD_DEVIATION 1.21 • n=40 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
—
|
—
|
-0.95 Z-score
STANDARD_DEVIATION 1.17 • n=119 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
|
Bradbury Cyanide level cassava flour
|
28.89 parts per million
STANDARD_DEVIATION 33.10 • n=79 Participants
|
22.03 parts per million
STANDARD_DEVIATION 24.39 • n=40 Participants
|
28.89 parts per million
STANDARD_DEVIATION 33.10 • n=79 Participants
|
22.03 parts per million
STANDARD_DEVIATION 24.39 • n=40 Participants
|
26.87 parts per million
STANDARD_DEVIATION 27.23 • n=238 Participants
|
|
Child urine thiocyanate
|
179.37 Micromol per Liter
STANDARD_DEVIATION 207.35 • n=79 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
227.57 Micromol per Liter
STANDARD_DEVIATION 193.85 • n=40 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
—
|
—
|
208.45 Micromol per Liter
STANDARD_DEVIATION 202.33 • n=119 Participants • This measure is applicable to children only. Data were not collected from caregivers.
|
|
Caregiver anxiety
|
—
|
—
|
3.29 score on a scale
STANDARD_DEVIATION 2.96 • n=79 Participants • This measure is applicable to caregivers only. Data were not collected from children.
|
3.35 score on a scale
STANDARD_DEVIATION 2.76 • n=40 Participants • This measure is applicable to caregivers only. Data were not collected from children.
|
3.31 score on a scale
STANDARD_DEVIATION 2.88 • n=119 Participants • This measure is applicable to caregivers only. Data were not collected from children.
|
|
Caregiver depression
|
—
|
—
|
3.01 score on a scale
STANDARD_DEVIATION 2.37 • n=79 Participants • This measure is applicable to caregivers only. Data were not collected from children.
|
2.38 score on a scale
STANDARD_DEVIATION 2.54 • n=40 Participants • This measure is applicable to caregivers only. Data were not collected from children.
|
2.80 score on a scale
STANDARD_DEVIATION 2.86 • n=119 Participants • This measure is applicable to caregivers only. Data were not collected from children.
|
PRIMARY outcome
Timeframe: Month 6, month 12Population: Children
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
Outcome measures
| Measure |
MISC and WTM, Children
n=79 Participants
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
n=40 Participants
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
|---|---|---|
|
Mullen Scales of Early Learning (MSEL) Composite Score
Month 6
|
73.63 t-score
Standard Error 1.33
|
74.33 t-score
Standard Error 1.90
|
|
Mullen Scales of Early Learning (MSEL) Composite Score
Month 12
|
77.04 t-score
Standard Error 1.48
|
76.75 t-score
Standard Error 1.93
|
PRIMARY outcome
Timeframe: Month 6, month 12Population: Children
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.
Outcome measures
| Measure |
MISC and WTM, Children
n=79 Participants
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
n=40 Participants
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
|---|---|---|
|
Child Urine Thiocyanite Level
Month 6
|
74.98 Micromol per Liter
Standard Error 13.94
|
139.00 Micromol per Liter
Standard Error 20.17
|
|
Child Urine Thiocyanite Level
Month 12
|
146.45 Micromol per Liter
Standard Error 14.36
|
108.91 Micromol per Liter
Standard Error 20.18
|
SECONDARY outcome
Timeframe: Month 6, month 12Population: Children
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.
Outcome measures
| Measure |
MISC and WTM, Children
n=79 Participants
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
n=40 Participants
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
|---|---|---|
|
Home Observation for the Measurement of the Environment (HOME) Score
Month 6
|
69.37 score on a scale
Standard Error 1.70
|
67.61 score on a scale
Standard Error 2.42
|
|
Home Observation for the Measurement of the Environment (HOME) Score
Month 12
|
71.49 score on a scale
Standard Error 1.84
|
68.07 score on a scale
Standard Error 2.42
|
SECONDARY outcome
Timeframe: Month 6, month 12Population: Children
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.
Outcome measures
| Measure |
MISC and WTM, Children
n=79 Participants
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
n=40 Participants
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
|---|---|---|
|
Child Physical Growth: Length for Age Z-score
Month 6
|
-1.72 z-score
Standard Error 0.09
|
-1.88 z-score
Standard Error 0.13
|
|
Child Physical Growth: Length for Age Z-score
Month 12
|
-1.57 z-score
Standard Error 0.10
|
-1.96 z-score
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Month 6, month 12Population: Children
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.
Outcome measures
| Measure |
MISC and WTM, Children
n=79 Participants
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
n=40 Participants
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
|---|---|---|
|
Child Physical Growth: Weight for Age Z-score
Month 6
|
-1.54 z-score
Standard Error 0.12
|
-1.92 z-score
Standard Error 0.16
|
|
Child Physical Growth: Weight for Age Z-score
Month 12
|
-1.40 z-score
Standard Error 0.13
|
-2.10 z-score
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Month 6, month 12Population: Caregivers of children
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.
Outcome measures
| Measure |
MISC and WTM, Children
n=79 Participants
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
n=40 Participants
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
|---|---|---|
|
Caregiver Anxiety Symptoms
Month 6
|
2.86 score on a scale
Standard Error 0.28
|
3.91 score on a scale
Standard Error 0.40
|
|
Caregiver Anxiety Symptoms
Month 12
|
2.80 score on a scale
Standard Error 0.30
|
3.74 score on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Month 6, month 12Population: Caregivers of children
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.
Outcome measures
| Measure |
MISC and WTM, Children
n=79 Participants
Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
Mediational Intervention for Sensitizing Caregivers (MISC): The study team will use 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).
|
WTM Only, Children
n=40 Participants
WTM trainings only (recommended standard of care) bi-weekly for 12 months.
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 will be distributed to participating households. Women will receive this training bi-weekly for 12 months
|
|---|---|---|
|
Caregiver Depressive Symptoms
Month 6
|
2.21 score on a scale
Standard Error 0.29
|
4.25 score on a scale
Standard Error 0.42
|
|
Caregiver Depressive Symptoms
Month 12
|
2.45 score on a scale
Standard Error 0.32
|
4.18 score on a scale
Standard Error 0.42
|
Adverse Events
MISC and WTM, Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WTM Only, Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MISC and WTM, Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WTM Only, Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place