A Phase 3 interventional study of Responsive stimulation, female and male caregivers and Food provision and nutrition education in Early Childhood Development (ECD), sponsored by University of South Carolina. Not yet recruiting at 4 sites in Liberia. Open to participants aged 6 Months to 30 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by University of South Carolina · Phase 3, Interventional, and Prevention
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.
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.
University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Responsive stimulation, female and male caregivers
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.
Other: Food provision and nutrition education
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.
Behavioral: Responsive stimulation, female and male caregivers · Other: Food provision and nutrition education
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 months
Child height or length-for-age z-score
Change from baseline to end-line in child height or length-for-age z-score.
Time frame: 7 months
Child weight-for-age z-score
Change from baseline to end-line in child weight-for-age z-score.
Time frame: 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.
Time frame: 7 months
Child egg consumption
Change from baseline to end-line in percent children consuming at least 3 eggs in the past week
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 months
Child diarrhea
Change from baseline to end-line in percent children with at least one diarrheal episode in the past two weeks.
Time frame: 7 months
Child fever
Change from baseline to end-line in percent children with at least one fever in the past two weeks.
Time frame: 7 months
Child respiratory infection
Change from baseline to end-line in percent children with at least one respiratory infection in the past two weeks.
Time frame: 7 months
Child vomiting
Change from baseline to end-line in percent children with at least one instance of vomiting in the past two weeks.
Time frame: 7 months
Plan to share: 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).
Supporting information: Study protocol
Time frame: Final submission and release of the study data will occur approximately 12 months following the end of fieldwork and within the award period (or before the associated publication, whichever comes first). Study data deposited in DASH will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.
Access criteria: Scientific data (sum scores, item data, scale composites, transcripts) will be preserved and shared. Respondent identifiers will not be shared. There will be no additional limitations other than the controls and privacy protections described here. DASH is a NIH controlled-access data repository. The NICHD DASH Data Access Committee reviews all requests to access DASH data from identity-verified requesters, to determine whether the proposed use is scientifically and ethically appropriate and does not conflict with constraints or research data use limitations identified by the institutions that submitted the research data. The Recipient's institution and the Recipient must sign and agree to the terms and conditions in the NICHD DASH Data Use Agreement for accessing research data.
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Jun 2028, 16 months later.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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