An interventional study of Friendship Bench and Infant and Young Child Feeding (IYCF) Curriculum in Neurodevelopment and Child Growth, sponsored by University of Washington. Not yet recruiting. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
The goal of this randomized controlled trial is to adapt and test a package of interventions to provide nurturing care for children aged 0-2 years in three countries (Botswana, Kenya, Zimbabwe). Mothers living with and without HIV will be enrolled in pregnancy, and their children will be followed for two years. The main objectives of this study are to:
Researchers will compare children who receive the intervention package and those who do not to see if the interventions improve child neurodevelopment and growth. Researchers will also compare children with and without HIV exposure to see if there are improvements in neurodevelopment and growth for children who were exposed to HIV.
All participants will attend regular prenatal and postnatal care appointments. Participants who are randomized to receive the package of interventions will attend regularly scheduled visits where they will discuss problem-solving strategies, receive information on healthy foods for children, and learn about how to play with their children. Mothers receiving the intervention package will also have the opportunity to meet with other mothers and babies in small groups where their children can play together.
Prior to enrollment for the clinical trial, the three interventions will be culturally adapted and refined in Botswana and Kenya using a user-centered co-design approach. A 3-day participatory workshop will be held to select appropriate adaptations to the three interventions while maintaining core components. Following these adaptations, \~80 pregnant women/mother-infant pairs will be recruited for a formative pilot to further refine the three interventions. The workshop and pilot activities have already been completed in Zimbabwe under a different protocol.
Following the clinical trial, we will determine how the package of interventions works (or if it does not work, why) to improve child development. Hypothesized causal biological and behavioral pathways include maternal health, including mental health; infant health and nutrition; caregiving quality; and maternal-child interactions. Throughout the clinical trial, both quantitative and qualitative data will be collected to identify determinants of implementation, acceptability, feasibility, appropriateness, and cost of incorporating the intervention package and neurodevelopmental evaluations into regular maternal and child health services across the three countries. Costing data will also be collected from time and motion cards and study budget records to determine the incremental costs of incorporating the intervention package and neurodevelopmental evaluations in the three participating countries.
227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.
This study's planned enrollment of 1,260 is above the median of 413 across 143 interventional studies indexed under Growth Disorders.
Browse Growth Disorders studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention arm will combine three evidence-based interventions (Friendship Bench, infant and young child feeding curriculum, play-based learning curriculum) in a country-adapted package delivered by CHWs to participants starting in pregnancy and continuing through a child's second year of life. The intervention will be delivered at home, in the community, in a government clinic, or study clinic in the context of ongoing antenatal care and maternal and child health services for pregnant women, mothers, and children.
Behavioral: Friendship Bench · Behavioral: Infant and Young Child Feeding (IYCF) Curriculum · Behavioral: Play-Based Curriculum
The standard of care arm includes regular antenatal care and maternal and child health services. These services across the three countries include recommended antenatal care visits during which maternal/fetal health is assessed, antenatal tests are conducted, nutrition supplements and disease prophylaxis are provided, and basic education on danger signs, breastfeeding and nutrition are provided. Postnatal and infant care include family planning, growth monitoring, immunization, and assessment of child development.
After enrollment, participants randomized to BONDS will be linked to a community health worker (CHW) who will arrange Friendship Bench (FB) sessions. During the sessions, participants identify their current stressors, and work with CHWs to consider solutions and select and implement practical solutions.
Community health workers will deliver the infant and young child feeding (IYCF) curriculum between pregnancy and 2 years. Modules in pregnancy will focus on early breastfeeding initiation, exclusive breastfeeding (EBF), how to breastfeed and challenges with breastfeeding. Following birth, modules will reinforce education and support EBF through 6 months and then transition to the introduction of other foods and food preparation demonstrations with continued breastfeeding.
This parent-focused, play-based intervention addresses responsive caregiving and opportunities for early learning. The intervention will emphasize the importance of early learning experiences and adopting a growth mindset, with common themes including the use of scaffolding and "serve and return" activities.
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures social, language, fine motor and gross motor development using 138 direct observations of children's ability in each domain (gross motor: 36 items; fine motor: 36 items; language: 36 items; social: 30 items). A continuous standardized z-score will be derived based on the total number of items passed by the child across all four domains. Mean differences in total MDAT z-score at 24 months will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Total Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures social, language, fine motor and gross motor development using 138 direct observations of children's ability in each domain (gross motor: 36 items; fine motor: 36 items; language: 36 items; social: 30 items). A continuous standardized z-score will be derived based on the total number of items passed by the child across all four domains. Mean differences in total MDAT z-score at 12 months will be compared between the intervention and control arms.
Time frame: Study midline (child age: 12 months)
Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures gross motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT gross motor domain z-score at 24 months will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures fine motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT fine motor domain z-score at 24 months will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures social development using 30 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 30 items. Mean differences in MDAT social domain z-score at 24 months will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 24 months
MDAT measures language development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT language domain z-score at 24 months will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Composite Scores of the MacArthur Bates Communicative Development Inventories (CDI) Vocabulary Checklist
The MacArthur Bates CDI uses caregiver-reported assessments of a child's language acquisition. Caregivers are provided a checklist of the \~100 most commonly spoken words in each language that their child speaks. Mean differences in the number of words spoken will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Presence of Functional Difficulties as Assessed by the Washington Group/UNICEF Child Functioning Module (CFM)
The CFM assess functional difficulties across eight domains (vision, hearing, mobility, dexterity, communication, learning, playing, and controlling behavior), each assessed using 1-3 four-point Likert scales. The proportion of children with at least one functional difficulty across the eight domains will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Weight-for-age z-score (WAZ) at 24 months
WAZ will be calculated for each child at 24 months. Mean differences in WAZ will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Length-for-age z-score (LAZ) at 24 months
LAZ will be calculated for each child at 24 months. Mean differences in LAZ will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Weight-for-length z-score (WLZ) at 24 months
WLZ will be calculated for each child at 24 months. Mean differences in WLZ will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Head circumference-for-age z-score (HCAZ) at 24 months
HCAZ will be calculated for each child at 24 months. Mean differences in HCAZ will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Gross Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures gross motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT gross motor domain z-score at 12 months will be compared between the intervention and control arms.
Time frame: Study midline (child age: 12 months)
Fine Motor Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures fine motor development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT fine motor domain z-score at 12 months will be compared between the intervention and control arms.
Time frame: Study midline (child age: 12 months)
Social Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures social development using 30 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 30 items. Mean differences in MDAT social domain z-score at 12 months will be compared between the intervention and control arms.
Time frame: Study midline (child age: 12 months)
Language Domain Score on the Malawi Developmental Assessment Tool (MDAT) at 12 months
MDAT measures language development using 36 direct observations. A continuous standardized z-score will be will be derived based on the total number of items passed by the child across these 36 items. Mean differences in MDAT language domain z-score at 12 months will be compared between the intervention and control arms.
Time frame: Study midline (child age: 12 months)
Proportion of children who are stunted
The proportion of children who are stunted will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Proportion of children who are wasted
The proportion of children who are wasted will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Proportion of children who are underweight
The proportion of children who are underweight will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Proportion of mothers with mental distress at 12 months
Mothers are considered to have mental distress if they have a positive screening for depression and/or anxiety. The proportion of mothers with mental distress will be compared between the intervention and control arms.
Time frame: Study midline (child age: 12 months)
Proportion of mothers with mental distress at 24 months
Mothers are considered to have mental distress if they have a positive screening for depression and/or anxiety. The proportion of mothers with mental distress will be compared between the intervention and control arms.
Time frame: Study endline (child age: 24 months)
Proportion of mothers who did early initiation of breastfeeding
Early initiation of breastfeeding (defined as mothers who put the baby to the breast within the first hour of birth) will be obtained via maternal self-report. The proportion of women who initiated breastfeeding within one hour of birth will be compared between the intervention and control arms.
Time frame: First postnatal visit (0-2 weeks after delivery)
Proportion of infants who were exclusively breastfed through six months of age
Exclusive breastfeeding will be obtained via maternal self-report of breastfeeding through 6-months of age with no introduction of formula or complementary foods. The proportion of children who were exclusively breastfed for six months will be compared between the intervention and control arms.
Time frame: First postnatal visit (0-2 weeks after delivery) through child age 6 months
Overall breastfeeding duration
Overall breastfeeding duration will be measured continuously for each child as the number of months they were breastfed. This will be obtained from maternal self-report. Mean differences in the overall duration of breastfeeding will be compared between the intervention and control arms.
Time frame: First postnatal visit (0-2 weeks after delivery) through study endline (child age: 24 months)
No study locations are listed for this record.
Plan to share: Yes — All IPD that is not directly identifiable will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD will be available on NICHD DASH 12 months after the end of participant follow-up, which is anticipated to be December 2029. Supporting information (protocol, ICFs, SAPs) is anticipated to be available on ct.gov by May 2027.
Access criteria: IPD will be available open access on NICHD DASH. Supporting information will be available open access on ct.gov.
Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.
Of 77 non-industry interventional studies with no phase under Growth Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 30. This study's planned 37 months is above that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 12 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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