Challenges Conducting a Comparative Effectiveness Trial in a Fee-for-Service Mental Health Clinic Serving Young Children

Introduction:  Young children with high rates of behavior problems are more likely to be expelled from preschool, struggle with academic expectations, and have difficulty with peer relationships.  Parent training (PT) is a well-established and cost-effective intervention modality for reducing behavior problems in young children.  PT can be effectively delivered individually to families or in parent groups, though it is unclear whether one PT modality is more cost-effective or acceptable, particularly for families of color from low-income communities. To examine this question, an equivalence trial is being undertaken in an urban, fee-for-service mental health clinic serving predominantly African American families receiving Medicaid to compare the cost, effectiveness, and acceptability of two evidence-based PT programs that use different treatment modalities.  The purpose of this presentation is to describe the challenges associated with conducting a randomized equivalence trial in a fee-for-service setting where clinic policies required for financial survival run counter to those required for rigorous research.    

Methods:   This equivalence trial compares the cost, effectiveness, and social validity of an individually-delivered PT program (Parent-Child Interaction Therapy; PCIT) and a group-based PT program (Chicago Parent Program; CPP).  Two-hundred-sixty-two children (2-5 years old) and their parents are being recruited and randomized in blocks of 10 to PCIT or CPP. Parents interested in participating must first complete a series of intake and diagnostic procedures prior to consenting for the study and a treatment evaluation interview before initiating PT.  Thirteen clinic therapists trained in either PCIT or CPP are also participating. 

Results: To date, 73 parent-child dyads have enrolled; 50% below target enrollment.  Multiple challenges have been identified including lengthy intake, triage, and diagnostic processes contributing to family attrition before consent; low treatment attendance rates after consent, despite high parent satisfaction ratings; balance between expectations for clinician productivity and those required by the research design; insurance policies that prohibit multiple treatment sessions for the same child in the same day; and early discharge policies required by the clinic when patients are “non-compliant.”  Multiple strategies to address these challenges have been negotiated with clinicians and clinic administrators with some success. 

Conclusions:  Many of the policies established by insurance companies and fee-for-service clinics pose important challenges that can affect study integrity.  However, they can also pose opportunities for creating new procedures that can enhance study validity and improve treatment outcomes in real-world settings.