Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Neurodevelopment at 24 months |
The Malawi Developmental Assessment Tool (MDAT) will be used to assess neurodevelopment. MDAT provides an independent evaluation of development in the domains of gross motor, fine motor, language and social skills. The MDAT can be administered in any environment as it requires minimal equipment and is more culturally relevant to our context. The scores from the MDAT are relatable and comparable to those obtained from the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III). Primary outcomes will be z-scores from four neurodevelopmental domain measurements-gross motor, fine motor, language, and social. |
24months |
|
Secondary |
Neurodevelopment at 12 months |
The Malawi Developmental Assessment Tool (MDAT) will be used to assess neurodevelopment. MDAT provides an independent evaluation of development in the domains of gross motor, fine motor, language and social skills. The MDAT can be administered in any environment as it requires minimal equipment and is more culturally relevant to our context. The scores from the MDAT are relatable and comparable to those obtained from the BSID-III. Primary outcomes will be z-scores from four neurodevelopmental domain measurements-gross motor, fine motor, language, and social. |
12 months |
|
Secondary |
Language development at 12 months |
Children's language development will be assessed at 12 and 24 months using an adapted MacArthur-Bates Communicative Development Inventories (CDI) tool. |
12 months |
|
Secondary |
Language development at 24 months |
Children's language development will be assessed at 12 and 24 months using an adapted MacArthur-Bates Communicative Development Inventories (CDI) tool. |
24 months |
|
Secondary |
Quality of child's environment at 12 months |
The Home Observation Measurement of the Environment-Short Form (HOME-SF) will be used to asses the quality of the child's environment. HOME for children 0-3 is designed to observe parental responsivity, acceptance of the child, organization of the environment, learning materials, parental involvement, and variety within the home environment through 45 items. |
12 months |
|
Secondary |
Quality of child's environment at 24 months |
The Home Observation Measurement of the Environment-Short Form (HOME-SF) will be used to asses the quality of the child's environment. HOME for children 0-3 is designed to observe parental responsivity, acceptance of the child, organization of the environment, learning materials, parental involvement, and variety within the home environment through 45 items. |
24 months |
|
Secondary |
Child's age-specific tasks at 24 weeks |
The Caregiver Reported Early Development Instrument (CREDI) will be used to assess age-specific tasks for early childhood 0-36 months. It is intended to be used at a population level to detect developmental delay, not as an individual diagnostic tool. This open-source, psychometrically sound tool has been tested in over 15 low-and-middle-income countries and is culturally and linguistically neutral. When deployed in its long form it can be analyzed by specific developmental domains including (motor, language and cognitive, socio-emotional). CREDI scores per arm will be described in z-scores from four neurodevelopmental domain measurements. |
24 weeks |
|
Secondary |
Child's age-specific tasks at 12 months |
The Caregiver Reported Early Development Instrument (CREDI) will be used to assess age-specific tasks for early childhood 0-36 months. It is intended to be used at a population level to detect developmental delay, not as an individual diagnostic tool. This open-source, psychometrically sound tool has been tested in over 15 low-and-middle-income countries and is culturally and linguistically neutral. When deployed in its long form it can be analyzed by specific developmental domains including (motor, language and cognitive, socio-emotional). CREDI scores per arm will be described in z-scores from four neurodevelopmental domain measurements. |
12 months |
|
Secondary |
Child's age-specific tasks at 18 months |
The Caregiver Reported Early Development Instrument (CREDI) will be used to assess age-specific tasks for early childhood 0-36 months. It is intended to be used at a population level to detect developmental delay, not as an individual diagnostic tool. This open-source, psychometrically sound tool has been tested in over 15 low-and-middle-income countries and is culturally and linguistically neutral. When deployed in its long form it can be analyzed by specific developmental domains including (motor, language and cognitive, socio-emotional). CREDI scores per arm will be described in z-scores from four neurodevelopmental domain measurements. |
18 months |
|
Secondary |
Child's age-specific tasks at 24 months |
The Caregiver Reported Early Development Instrument (CREDI) will be used to assess age-specific tasks for early childhood 0-36 months. It is intended to be used at a population level to detect developmental delay, not as an individual diagnostic tool. This open-source, psychometrically sound tool has been tested in over 15 low-and-middle-income countries and is culturally and linguistically neutral. When deployed in its long form it can be analyzed by specific developmental domains including (motor, language and cognitive, socio-emotional). CREDI scores per arm will be described in z-scores from four neurodevelopmental domain measurements. |
24 months |
|
Secondary |
Caregiver mental health and wellbeing at 24 weeks |
The Self-Reporting Questionnaire 20 (SQR-20) will be used to assess Caregiver mental health and wellbeing. The SQR-20 has 20 questions that assess for common mental health conditions and common physical manifestations of depression or anxiety (e.g., poor appetite, poor sleep, anhedonia). There are 20 questions and more yes answers correlate with higher risk for mental health concerns. |
24 weeks |
|
Secondary |
Caregiver mental health and wellbeing at 12 months |
The Self-Reporting Questionnaire 20 (SQR-20) will be used to assess Caregiver mental health and wellbeing. The SQR-20 has 20 questions that assess for common mental health conditions and common physical manifestations of depression or anxiety (e.g., poor appetite, poor sleep, anhedonia). There are 20 questions and more yes answers correlate with higher risk for mental health concerns. |
12 months |
|
Secondary |
Caregiver mental health and wellbeing at 18 months |
The Self-Reporting Questionnaire 20 (SQR-20) will be used to assess Caregiver mental health and wellbeing. The SQR-20 has 20 questions that assess for common mental health conditions and common physical manifestations of depression or anxiety (e.g., poor appetite, poor sleep, anhedonia). There are 20 questions and more yes answers correlate with higher risk for mental health concerns. |
18 months |
|
Secondary |
Caregiver mental health and wellbeing at 24 months |
The Self-Reporting Questionnaire 20 (SQR-20) will be used to assess Caregiver mental health and wellbeing. The SQR-20 has 20 questions that assess for common mental health conditions and common physical manifestations of depression or anxiety (e.g., poor appetite, poor sleep, anhedonia). There are 20 questions and more yes answers correlate with higher risk for mental health concerns. |
24 months |
|