title: Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families?
abstract: BACKGROUND
  Untreated behavioral and mental health problems beginning in early childhood are costly problems affecting the long-term health and wellbeing of children, their families, and society. Although parent training (PT) programs have been demonstrated to be a cost-effective intervention modality for treating childhood behavior problems, they have been less effective for children from low-income and underserved racial and ethnic populations. The purpose of this randomized trial is to compare the effectiveness, cost, and social validity of two manualized evidence-based PT programs that were developed and tested on different populations and employ different delivery models: (1) The Chicago Parent Program (CPP), a group-based program developed in collaboration with a community advisory board of African-American and Latino parents; and (2) Parent-Child Interaction Therapy (PCIT), an individualized parent-child coaching model considered to be 'the gold standard' for parents of children with externalizing behavior problems.
  
  
  METHODS
  This trial uses an experimental design with randomization of parents seeking behavioral treatment for their 2- to 5-year-old children at a mental health clinic in Baltimore, MD (80% African-American or multi-racial; 97% receiving Medicaid). Using block randomization procedures, 262 parents are randomized to CPP or PCIT. Clinicians (n=13) employed in the mental health clinic and trained in CPP or PCIT are also recruited to participate. Primary outcomes of interest are reductions in child behavior problems, improvements in parenting, perceived value of the interventions from the perspective of parents and clinicians, and cost. Parent distress and family social risk are assessed as modifiers of treatment effectiveness. We hypothesize that CPP will be at least as effective as PCIT for reducing child behavior problems and improving parenting but the programs will differ on cost and their social validity as perceived by parents and clinicians.
  
  
  CONCLUSIONS
  This is the first study to compare the effectiveness of a PT program originally designed with and for parents from underserved racial and ethnic populations (CPP) against a well-established program considered to be the 'the gold standard' (PCIT) with a high-risk population of parents. Challenges related to conducting a randomized trial in a fee-for-service mental health clinic serving urban, low-income families are discussed.
  
  
  BACKGROUND
  NCT01517867.
authors.affiliation: Johns Hopkins University School of Nursing, 525 North Wolfe Street, Baltimore, MD 21205, USA. Debgross@jhu.edu.
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Gross
authors.forename: Harolyn M E
authors.initials: HM
authors.lastname: Belcher
authors.forename: Mirian E
authors.initials: ME
authors.lastname: Ofonedu
authors.forename: Susan
authors.initials: S
authors.lastname: Breitenstein
authors.forename: Kevin D
authors.initials: KD
authors.lastname: Frick
authors.forename: Budhathoki
authors.initials: B
authors.lastname: Chakra
mesh_terms: D015142:Baltimore / Q000453:epidemiology; D002652:Child Behavior; D002653:Child Behavior Disorders / Q000175:diagnosis / Q000191:economics / Q000208:ethnology / Q000523:psychology / Q000628:therapy*; D002675:Child, Preschool; D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D004505:Education, Nonprofessional / Q000191:economics / Q000379:methods*; D018588:Fee-for-Service Plans / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D008603:Mental Health; D008605:Mental Health Services / Q000191:economics; D010287:Parent-Child Relations; D016487:Parenting / Q000208:ethnology / Q000523:psychology; D010290:Parents / Q000193:education* / Q000523:psychology; D011203:Poverty / Q000191:economics / Q000208:ethnology / Q000523:psychology; D015397:Program Evaluation; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome