Effect of caregiver training on neurodevelopment of HIV-exposed uninfected children and caregiver mental health: a Ugandan cluster randomized controlled trial

Objective—Early childhood development (ECD) programs typically combine healthy nutrition and cognitive stimulation in an integrated model. We separately delivered these two components in a cluster randomized controlled trial (RCT) to evaluate their comparative effectiveness in promoting healthy child development and caregiver mental health. This is the first study to do so for HIV-affected children and their infected mothers,.

Methods—221 HIV-exposed but uninfected (HEU) child (2 to 3 years old) and caregiver dyads in 18 geographic clusters in Eastern Uganda were randomized by cluster to receive biweekly individualized sessions of either 1) Mediational Intervention for Sensitizing Caregivers (MISC) training emphasizing cognitive stimulation, or 2) Uganda Community Based Association for Child Welfare program that delivered (UCOBAC) health and nutrition training. Children were evaluated at baseline, six months, one year (training conclusion), and one-year post-training with the Mullen Scales of Early Learning (MSEL), the Color-Object Association Test (COAT) for memory, the Early Childhood Vigilance Test (ECVT) of attention, and the Behavior Rating Inventory of Executive Function (BRIEF-parent). The Caldwell HOME was completed by observers to gauge caregiving quality after training. Caregiver depression/anxiety (Hopkins Symptom Checklist-25) and functionality (list of activities of daily living) were also evaluated. Data collectors were blinded to trial arm assignment.

Results—MISC resulted in significantly better quality of caregiving compared to UCOBAC mid- intervention with an adjusted mean difference (MadjDiff ) of 2.34 (95% CI: 1.54, 3.15, p

Conclusions—Even though MISC demonstrated an advantage of improving caregiving quality, it did not produce better child cognitive outcomes compared to health and nutrition training.