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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD098588 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MISC and WTM | Experimental | Wetting method (WTM)+ Mediational Intervention for Sensitizing Caregivers (MISC) bi-weekly for 12 months. |
|
| WTM only | Active Comparator | WTM trainings only (recommended standard of care) bi-weekly for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Boivin, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute National of Research National (INRB) | Kinshasa | Democratic Republic of the Congo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23460617 | Background | 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. | |
| 28807191 | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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 |
| FG002 | 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). |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Children | Posted | Least Squares Mean | Standard Error | t-score | Month 6, month 12 |
|
12 months after enrollment into the study
Adverse events were determined as part of study assessments at months 6 and 12.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 were distributed to participating households. Women received this training bi-weekly for 12 months. 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). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J Boivin | Michigan State University | 1-517-884-0281 | boivin@msu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2020 | Mar 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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). |
|
| 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 |
| 23530166 | 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. |
| 29664942 | 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. |
| BG001 | 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 |
| BG002 | 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). |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Child Mullen Scales Learning Composite | 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 10 in the Western population. Higher scores reflect better outcome. | This measure is applicable to children only. Data were not collected from caregivers. | Mean | Standard Deviation | t-score |
|
| HOME score quality caregiving | 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. | This measure is applicable to children only. Data were not collected from caregivers. | Mean | Standard Deviation | score on a scale |
|
| Child Length for age z-score | Length for age z-score was determined using the World Health Organization (WHO) 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. | This measure is applicable to children only. Data were not collected from caregivers. | Mean | Standard Deviation | Z-score |
|
| Child weight-for-age z-score | Weight for age z-score was determined using the World Health Organization (WHO) algorithm using child's length, sex, and age at the time of measurement. The world population mean is 0 with standard deviation 1. | This measure is applicable to children only. Data were not collected from caregivers. | Mean | Standard Deviation | Z-score |
|
| Bradbury Cyanide level cassava flour | A sample of household cassava flour was collected and sent to the laboratory. Cyanide content was measured in parts per million (ppm). The WHO safe limit is 10 ppm. The range in this study was 0-200 ppm. Greater value reflects worse outcome. This is a household-level measure; household includes child and caregiver. | Mean | Standard Deviation | parts per million |
|
| Child urine thiocyanate | 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. | This measure is applicable to children only. Data were not collected from caregivers. | Mean | Standard Deviation | Micromol per Liter |
|
| Caregiver anxiety | 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. | This measure is applicable to caregivers only. Data were not collected from children. | Mean | Standard Deviation | score on a scale |
|
| Caregiver depression | 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. | This measure is applicable to caregivers only. Data were not collected from children. | Mean | Standard Deviation | score on a scale |
|
| OG001 | 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 |
|
|
|
| Primary | 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. | Children | Posted | Least Squares Mean | Standard Error | Micromol per Liter | Month 6, month 12 |
|
|
|
|
| Secondary | 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. | Children | Posted | Least Squares Mean | Standard Error | score on a scale | Month 6, month 12 |
|
|
|
|
| Secondary | 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. | Children | Posted | Least Squares Mean | Standard Error | z-score | Month 6, month 12 |
|
|
|
|
| Secondary | 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. | Children | Posted | Least Squares Mean | Standard Error | z-score | Month 6, month 12 |
|
|
|
|
| Secondary | 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. | Caregivers of children | Posted | Least Squares Mean | Standard Error | score on a scale | Month 6, month 12 |
|
|
|
|
| Secondary | 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. | Caregivers of children | Posted | Least Squares Mean | Standard Error | score on a scale | Month 6, month 12 |
|
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | 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 were distributed to participating households. Women received this training bi-weekly for 12 months. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | 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 were distributed to participating households. Women received this training bi-weekly for 12 months. 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). | 0 | 79 | 0 | 79 | 0 | 79 |
| EG003 | 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 were distributed to participating households. Women received this training bi-weekly for 12 months. | 0 | 40 | 0 | 40 | 0 | 40 |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
WTM only minus MISC and WTM |
| Superiority |
The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model. |
| The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests. | Mixed Models Analysis | Baseline value of the outcome, household material possessions, the HOME score, and child's age and sex were adjusted for in the model. | .13 | P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05. | Mean Difference (Final Values) | -37.53 | Standard Error of the Mean | 24.86 | 2-Sided | 95 | -86.92 | 11.85 | WTM only minus MISC and WTM | Superiority | The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model. |
The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model. |
| The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes. | Mixed Models Analysis | Baseline value of the outcome and household material possessions were adjusted for in the model. | .26 | P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05. | Mean Difference (Final Values) | -3.42 | Standard Error of the Mean | 3.05 | 2-Sided | 95 | -9.48 | 2.63 | WTM only minus MISC and WTM | Superiority | The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model. |
The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model. |
| The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes. | Mixed Models Analysis | Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model. | .02 | P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05. | Mean Difference (Final Values) | -0.39 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -0.72 | -0.06 | WTM only minus MISC and WTM | Superiority | The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model. |
The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model. |
| The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes. | Mixed Models Analysis | Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model. | .001 | P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05. | Mean Difference (Final Values) | -0.70 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | -1.11 | -0.28 | WTM only minus MISC and WTM | Superiority | The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model. |
The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model. |
| The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes. | Mixed Models Analysis | Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model. | .07 | P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05. | Mean Difference (Final Values) | 0.94 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -0.08 | 1.96 | WTM only minus MISC and WTM | Superiority | The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model. |
The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model. |
| The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes. | Mixed Models Analysis | Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model. | <.01 | P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05. | Mean Difference (Final Values) | 1.73 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | 0.67 | 2.79 | WTM only minus MISC and WTM | Superiority | The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model. |