Child Adult Relationship Enhancement in Primary Care (PriCARE): study design/protocol for a randomized trial of a primary care-based group parenting intervention to prevent child maltreatment

This study is a multicenter randomized controlled trial with two parallel arms. Children, 2 –6 years old with Medicaid/CHIP/no insurance, and their English- and Spanish-speaking caregivers recruited from pediatric primary care clinics in Philadelphia and North Carolina will be enrolled. Caregivers assigned to the intervention regimen will attend PriCARE/CARI ÑO and receive usual care. Caregivers assigned to the control regimen will receive usual care only. The primary outcome is occurrence of an investigation for CM by child protective services during the 48 months following completion of the intervention. In addition, scores for CM risk, child behavior problems, harsh and neglectful parenting behaviors, caregiver stress, and caregiver-child interactions will be assessed as secondary outcome measures and for investigation of possible mechanisms of intervention-induced change. We will also identify PriCARE/CARI ÑO implementation factors that may be barriers and facilitators to intervention referrals, enrollment, and attendance.DiscussionBy evaluating proximal outcomes in addition to the distal outcome of CM, this study, the largest CM prevention trial with individual randomization, will help elucidate mechanisms of change and advance the science of CM prevention. This study will also gather critical information on factors influencing successful implementation and how to optimize intervention referrals, enrollment, and attendance to inform future dissemination and practical...
Source: Trials - Category: Research Source Type: clinical trials