Early Childhood Development (ECD)Phase 3BUNDLENCT07490899
Combined Nutrition and Parenting Study
A Phase 3 study testing Responsive stimulation, female and male caregivers and Food provision and nutrition education in people with Early Childhood Development (ECD), run by University of South Carolina at 4 sites in Liberia.
Trial summary
This study aims to evaluate whether early childhood development is improved by a bundled set of interventions that promote responsive stimulation and improved nutrition by the provision of eggs and dried fish (nutrient-dense animal source foods), and whether, in combination, these stimulation and nutrition… Read more about this study
- Who is it for?
- Ages 6 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Development (ECD)
- What is being tested?
- Responsive stimulation, female and male caregivers and Food provision and nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,240 participants
- Where
- 4 sitesLiberia
- Study dates
- Feb 2027to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Resides in selected community in Liberia
- Household has a child aged 6-30 months at study enrollment
- Child has a primary female caregiver and second (male or female) caregiver ≥ 18 years of age
- Caregivers and child intend to continue residing in the study area for the follow-up duration
- Both primary and second caregiver provide informed consent
Who cannot join
- Children with known allergies to eggs or fish
- Caregivers with cognitive and severe physical disabilities who are unable to implement intervention activities
- Children with developmental disabilities
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Edward Frongillo, PhD contact
Liberia4 sites
Plan International
Kakata
Leila Larson, PhD MPH, 803-576-5649, larsonl@mailbox.sc.edu
Plan International
Sanniquellie
Leila Larson, PhD MPH, 803-576-5649, larsonl@mailbox.sc.edu
Plan International
Tubmanburg
Leila Larson, PhD MPH, 803-576-5649, larsonl@mailbox.sc.edu
Plan International
Voinjama
Leila Larson, PhD MPH, 803-576-5649, larsonl@mailbox.sc.edu
About this study
Official title: Impact of Combined Nutrition, Responsive Parenting, and Health Intervention on Childhood Development Study
This study aims to evaluate whether early childhood development is improved by a bundled set of interventions that promote responsive stimulation and improved nutrition by the provision of eggs and dried fish (nutrient-dense animal source foods), and whether, in combination, these stimulation and nutrition interventions are more effective than responsive stimulation or food provision alone.
Read the detailed description
The BUNDLE study will examine the effects of a 7-month nutrition and caregiving intervention for female and male caregivers delivered by trained adult community facilitators in rural communities across Liberia. The study will use a four-arm 2x2 factorial cluster randomized design to test the effectiveness of the interventions on primary outcomes of child cognitive, language, motor, and socio-emotional development. In this study, 2240 children aged 6 to 30 months will be recruited from 160 rural communities randomized to a comparison arm or one of the three intervention arms. The comparison arm will receive the local standard of care. Three intervention arms will also receive either a responsive stimulation intervention with female and male caregivers, provision of eggs and dried fish accompanied by nutrition education, or responsive stimulation + provision of eggs and dried fish. We hypothesize that child development will be improved in all intervention arms compared to the comparison arm and in the combined intervention arm compared to the single intervention arms.
- Conditions
- Early Childhood Development (ECD)
- Being tested
- Responsive stimulation, female and male caregivers, Food provision and nutrition education
- Keywords
- cluster randomized trial, responsive caregiving, nutrition, early childhood development, animal source food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responsive stimulation, female and male caregiversBehavioural
Caregiving-related social and behavior change (SBC) messages and activities for primary female and secondary (male or female) caregivers focused on responsive stimulation, encompassing responsive caregiver-child interactions and the provision of early learning opportunities.
Food provision and nutrition educationOther
Provision of eggs and dried Bonny fish. Nutrition-related social and behavior change (SBC) messages focused on infant and young child feeding (IYCF), the importance of feeding the child eggs and dried fish, and ways to feed these foods to the child.
| Study group | Role | What they receive |
|---|---|---|
| Responsive Stimulation, female and male caregivers | Experimental | Adult community facilitators will facilitate peer group sessions with primary female secondary (male or female) caregivers using Plan International's adapted Responsive Caregiving curriculum. Caregivers will be encouraged to bring their children to the sessions to practice the learned activities. Facilitators will deliver key messages and allow participants to practice learned activities and provide them with feedback and encouragement. The sessions will focus on practice, problem-solving, and peer support. Sessions will be conducted fortnightly for 7 months. Each session will last approximately 60-90 minutes. Home visits will be conducted by the facilitators every 2.5 months to provide one-on-one support to the caregivers around the intervention activities. Receives: Behavioral: Responsive stimulation, female and male caregivers |
| Nutrition | Experimental | Households will receive weekly provisions of 7 eggs and 3 pieces of dried Bonny fish for the participating child, and an additional 3 eggs and 1 piece of fish to share. At the start of the intervention, Community Health Assistants will provide a group nutrition education session focused on the importance of feeding the child eggs and dried fish, ways to feed these foods to the child, and on infant and young child feeding more generally. This session will last 60-90 minutes. Brief nutrition messages will be reinforced when the food is delivered to households on a fortnightly basis. Receives: Other: Food provision and nutrition education |
| Responsive stimulation + Nutrition, female and male caregivers | Experimental | This arm is a combination of the responsive stimulation arm and the nutrition arm. Briefly, adult community facilitators will facilitate peer group sessions with primary female and secondary (male or female) caregivers using Plan International's adapted Responsive Caregiving curriculum. Households will also receive weekly provisions of 7 eggs and 3 pieces of dried Bonny fish for the participating child, and an additional 3 eggs and 1 piece of fish to share. They will also receive nutrition education. Receives: Behavioral: Responsive stimulation, female and male caregivers; Other: Food provision and nutrition education |
| Standard of care control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Development
Change from baseline to end-line in cognitive composite score on Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 162 with higher scores representing higher cognitive development.
Measured: 7 months
Language Development
Change from baseline to end-line in language composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 158 with higher scores representing higher language development.
Measured: 7 months
Motor Development
Change from baseline to end-line in motor composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 208 with higher scores representing higher motor development.
Measured: 7 months
Socio-emotional Development
Change from baseline to end-line in socio-emotional score on the Wolke Behavior Rating scale. Scores range from 9 to 81 with higher scores representing higher socio-emotional development.
Measured: 7 months
Secondary outcomes (27)
Child height or length-for-age z-score
Change from baseline to end-line in child height or length-for-age z-score.
Measured: 7 months
Child weight-for-age z-score
Change from baseline to end-line in child weight-for-age z-score.
Measured: 7 months
Child weight-for-height (or length) z-score
Change from baseline to end-line in child weight-for-height (or length) z-score.
Measured: 7 months
Child egg consumption
Change from baseline to end-line in percent children consuming at least 3 eggs in the past week
Measured: 7 months
Child fish consumption
Change from baseline to end-line in percent children consuming at least 1 piece of fish in the past week
Measured: 7 months
Child dietary diversity
Change from baseline to end-line in child dietary diversity score defined as number of food groups out of a total of eight food groups consumed in the previous 7 days based on World Health Organization guidelines and is assessed in children aged six months or older.
Measured: 7 months
Responsive feeding
Change from baseline to end-line in responsive feeding score assessed using the responsive feeding assessment. Scores range from 8 to 32 with higher scores representing higher responsive feeding behaviors.
Measured: 7 months
Early learning opportunities
Change from baseline to end-line in early learning opportunities score assessed using the Tool for Early learning. Scores range from 0 to 14 with higher scores representing more opportunities for early learning.
Measured: 7 months
Primary female caregiver social support
Change from baseline to end-line in primary female caregiver perceived social support assessed using the Multidimensional Scale of Perceived Social Support. Scores range from 12 to 84 with higher scores representing higher social support.
Measured: 7 months
Primary female caregiver responsive caregiver-child interactions
Change from baseline to end-line in proportion of responsive interactions between the primary female caregiver and child assessed using the Tool for Responsive Care.
Measured: 7 months
Male caregiver responsive caregiver-child interactions
Change from baseline to end-line in proportion of responsive interactions between the male caregiver and child assessed using the Tool for Responsive Care.
Measured: 7 months
Secondary female caregiver responsive caregiver-child interactions
Change from baseline to end-line in proportion of responsive interactions between the secondary female caregiver and child assessed using the Tool for Responsive Care.
Measured: 7 months
Primary female caregiver depression
Change from baseline to end-line in the primary female caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms.
Measured: 7 months
Male caregiver depression
Change from baseline to end-line in the male caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms.
Measured: 7 months
Secondary female caregiver depression
Change from baseline to end-line in the secondary female caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms.
Measured: 7 months
Primary female caregiver anxiety
Change from baseline to end-line in the primary female caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety.
Measured: 7 months
Male caregiver anxiety
Change from baseline to end-line in the male caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety.
Measured: 7 months
Secondary female caregiver anxiety
Change from baseline to end-line in the secondary female caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety.
Measured: 7 months
Primary female caregiver positive mental health
Change from baseline to end-line in the primary caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health.
Measured: 7 months
Male caregiver positive mental health
Change from baseline to end-line in the male caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health.
Measured: 7 months
Secondary female caregiver positive mental health
Change from baseline to end-line in the secondary female caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health.
Measured: 7 months
Primary female caregiver stress
Change from baseline to end-line in the primary female caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress.
Measured: 7 months
Male caregiver stress
Change from baseline to end-line in the male caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress.
Measured: 7 months
Secondary female caregiver stress
Change from baseline to end-line in the secondary female caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress.
Measured: 7 months
Primary female caregiver Co-parenting
Change from baseline to end-line in the primary female co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting.
Measured: 7 months
Male caregiver Co-parenting
Change from baseline to end-line in the male caregiver co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting.
Measured: 7 months
Secondary female caregiver Co-parenting
Change from baseline to end-line in the secondary female caregiver co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startFeb 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood Development (ECD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In Bomi, Lofa, Nimba, and Margibi counties in Liberia, 40 rural communities in each county will be randomly selected with equal probability per county, for a total of 160 communities. Each community will be randomized to a comparison arm or one of three intervention arms; randomization will be stratified by county. Using household listings in each community, 14 households fitting the study's eligibility criteria will be randomly selected and invited to participate in the study. Random selection of households will continue until 14 households have provided informed consent. If fewer than 14 eligible households are found, additional households will be selected using the same procedure from a neighboring rural community.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Plan International, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Leila Larson, University of South Carolina
- Investigators
- Leila Larson, PhD MPH, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490899
- Sponsor's protocol ID
- 1R01HD116874-01
- Other IDs
- 1R01HD116874-01
- Acronym
- BUNDLE
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file. All other scientific data (sum scores, item data, scale composites) will be preserved and shared. Respondent identifiers will not be shared. Documentation to be made publicly available to the research community will include questionnaires and tools, a detailed User Guide, a codebook with univariate statistics for each variable, and study-level metadata following the Data Documentation Initiative specification. Each variable in the codebook will include a brief description of the item along with the question number and question text from the questionnaire, variable name, variable label, value labels, and standard codes for missing values-including codes for non-applicable, "don't know," and refusal. Documentation will be provided in portable document format (PDF).
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combined Nutrition, Responsive Parenting, and Health Intervention on Childhood Development Study
- ClinicalTrials.gov ID
- NCT07490899
- Acronym / sponsor ID
- BUNDLE / 1R01HD116874-01
- Conditions
- Early Childhood Development (ECD)
- Keywords
- cluster randomized trial, responsive caregiving, nutrition, early childhood development, animal source food
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,240 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Plan International, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate whether early childhood development is improved by a bundled set of interventions that promote responsive stimulation and improved nutrition by the provision of eggs and dried fish (nutrient-dense animal source foods), and whether, in combination, these stimulation and nutrition interventions are more effective than responsive stimulation or food provision alone.
Detailed description
The BUNDLE study will examine the effects of a 7-month nutrition and caregiving intervention for female and male caregivers delivered by trained adult community facilitators in rural communities across Liberia. The study will use a four-arm 2x2 factorial cluster randomized design to test the effectiveness of the interventions on primary outcomes of child cognitive, language, motor, and socio-emotional development. In this study, 2240 children aged 6 to 30 months will be recruited from 160 rural communities randomized to a comparison arm or one of the three intervention arms. The comparison arm will receive the local standard of care. Three intervention arms will also receive either a responsive stimulation intervention with female and male caregivers, provision of eggs and dried fish accompanied by nutrition education, or responsive stimulation + provision of eggs and dried fish. We hypothesize that child development will be improved in all intervention arms compared to the comparison arm and in the combined intervention arm compared to the single intervention arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- In Bomi, Lofa, Nimba, and Margibi counties in Liberia, 40 rural communities in each county will be randomly selected with equal probability per county, for a total of 160 communities. Each community will be randomized to a comparison arm or one of three intervention arms; randomization will be stratified by county. Using household listings in each community, 14 households fitting the study's eligibility criteria will be randomly selected and invited to participate in the study. Random selection of households will continue until 14 households have provided informed consent. If fewer than 14 eligible households are found, additional households will be selected using the same procedure from a neighboring rural community.
| Arm | Type | Receives |
|---|---|---|
| Responsive Stimulation, female and male caregivers | Experimental | Behavioral: Responsive stimulation, female and male caregiversAdult community facilitators will facilitate peer group sessions with primary female secondary (male or female) caregivers using Plan International's adapted Responsive Caregiving curriculum. Caregivers will be encouraged to bring their children to the sessions to practice the learned activities. Facilitators will deliver key messages and allow participants to practice learned activities and provide them with feedback and encouragement. The sessions will focus on practice, problem-solving, and peer support. Sessions will be conducted fortnightly for 7 months. Each session will last approximately 60-90 minutes. Home visits will be conducted by the facilitators every 2.5 months to provide one-on-one support to the caregivers around the intervention activities. |
| Nutrition | Experimental | Other: Food provision and nutrition educationHouseholds will receive weekly provisions of 7 eggs and 3 pieces of dried Bonny fish for the participating child, and an additional 3 eggs and 1 piece of fish to share. At the start of the intervention, Community Health Assistants will provide a group nutrition education session focused on the importance of feeding the child eggs and dried fish, ways to feed these foods to the child, and on infant and young child feeding more generally. This session will last 60-90 minutes. Brief nutrition messages will be reinforced when the food is delivered to households on a fortnightly basis. |
| Responsive stimulation + Nutrition, female and male caregivers | Experimental | Behavioral: Responsive stimulation, female and male caregivers, Other: Food provision and nutrition educationThis arm is a combination of the responsive stimulation arm and the nutrition arm. Briefly, adult community facilitators will facilitate peer group sessions with primary female and secondary (male or female) caregivers using Plan International's adapted Responsive Caregiving curriculum. Households will also receive weekly provisions of 7 eggs and 3 pieces of dried Bonny fish for the participating child, and an additional 3 eggs and 1 piece of fish to share. They will also receive nutrition education. |
| Standard of care control | No intervention | – |
Who may qualify
- Ages
- 6 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Resides in selected community in Liberia
- Household has a child aged 6-30 months at study enrollment
- Child has a primary female caregiver and second (male or female) caregiver ≥ 18 years of age
- Caregivers and child intend to continue residing in the study area for the follow-up duration
- Both primary and second caregiver provide informed consent
Key exclusion criteria (3 listed)
- Children with known allergies to eggs or fish
- Caregivers with cognitive and severe physical disabilities who are unable to implement intervention activities
- Children with developmental disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Responsive stimulation, female and male caregiversCaregiving-related social and behavior change (SBC) messages and activities for primary female and secondary (male or female) caregivers focused on responsive stimulation, encompassing responsive caregiver-child interactions and the provision of early learning opportunities. | Behavioural | Responsive Stimulation, female and male caregivers, Responsive stimulation + Nutrition, female and male caregivers |
| Food provision and nutrition educationProvision of eggs and dried Bonny fish. Nutrition-related social and behavior change (SBC) messages focused on infant and young child feeding (IYCF), the importance of feeding the child eggs and dried fish, and ways to feed these foods to the child. | Other | Nutrition, Responsive stimulation + Nutrition, female and male caregivers |
Primary outcome
Cognitive Development
Time frame: 7 months
Change from baseline to end-line in cognitive composite score on Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 162 with higher scores representing higher cognitive development.
Language Development
Time frame: 7 months
Change from baseline to end-line in language composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 158 with higher scores representing higher language development.
Motor Development
Time frame: 7 months
Change from baseline to end-line in motor composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 208 with higher scores representing higher motor development.
Socio-emotional Development
Time frame: 7 months
Change from baseline to end-line in socio-emotional score on the Wolke Behavior Rating scale. Scores range from 9 to 81 with higher scores representing higher socio-emotional development.
27 secondary outcomes
Child height or length-for-age z-score
Time frame: 7 months
Child weight-for-age z-score
Time frame: 7 months
Child weight-for-height (or length) z-score
Time frame: 7 months
Child egg consumption
Time frame: 7 months
Child fish consumption
Time frame: 7 months
Child dietary diversity
Time frame: 7 months
Responsive feeding
Time frame: 7 months
Early learning opportunities
Time frame: 7 months
Primary female caregiver social support
Time frame: 7 months
Primary female caregiver responsive caregiver-child interactions
Time frame: 7 months
Male caregiver responsive caregiver-child interactions
Time frame: 7 months
Secondary female caregiver responsive caregiver-child interactions
Time frame: 7 months
Primary female caregiver depression
Time frame: 7 months
Male caregiver depression
Time frame: 7 months
Secondary female caregiver depression
Time frame: 7 months
Primary female caregiver anxiety
Time frame: 7 months
Male caregiver anxiety
Time frame: 7 months
Secondary female caregiver anxiety
Time frame: 7 months
Primary female caregiver positive mental health
Time frame: 7 months
Male caregiver positive mental health
Time frame: 7 months
Secondary female caregiver positive mental health
Time frame: 7 months
Primary female caregiver stress
Time frame: 7 months
Male caregiver stress
Time frame: 7 months
Secondary female caregiver stress
Time frame: 7 months
Primary female caregiver Co-parenting
Time frame: 7 months
Male caregiver Co-parenting
Time frame: 7 months
Secondary female caregiver Co-parenting
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file. All other scientific data (sum scores, item data, scale composites) will be preserved and shared. Respondent identifiers will not be shared. Documentation to be made publicly available to the research community will include questionnaires and tools, a detailed User Guide, a codebook with univariate statistics for each variable, and study-level metadata following the Data Documentation Initiative specification. Each variable in the codebook will include a brief description of the item along with the question number and question text from the questionnaire, variable name, variable label, value labels, and standard codes for missing values-including codes for non-applicable, "don't know," and refusal. Documentation will be provided in portable document format (PDF).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward Frongillo, PhD contact
Leila Larson, PhD MPH principal investigator
University of South Carolina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Responsive stimulation, female and male caregivers and Food provision and nutrition education in people with Early Childhood Development (ECD), run by University of South Carolina at 4 sites in Liberia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Liberia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leila Larson, PhD MPH (803-576-5649, larsonl@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Development (time frame: 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.