Clinical trial NCT03704974: The Impact of Parent Training on the Child's Health Services
Official title: The Impact of Evidence-Based Parent Training on Pediatric Health Services Utilization
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parenting
Child Rearing
Child Behavior Problem
Keywords: Child Health Services
Pediatric Health Service Utilization
Incredible Years
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: AltaMed Health Services Corporation
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-10-15
Enrollment: 7
Sex: ALL
Minimum age (years): 36
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children participating in the study will be referred from the AltaMed Federally Qualified Health Center, which manages the primary pediatric care at Children's Hospital Los Angeles for 20,000 children who generate 85,000 outpatient visits per year. The population reflects the diversity of Los Angeles County and is predominantly Latino.

Brief summary: The purpose of the study is to determine whether parent training with the Incredible Years Parent Program delivered in pediatric primary care decreases usage of healthcare services for the next year when compared to annual healthcare service use during the two years prior to the parents participating in program.

Detailed description: Pediatric health services utilization (pHSU) by children with mental health conditions demonstrated dramatic increases between 2006 and 2011. These national trends reflecting large increases in pHSU for mental health conditions were seen across multiple developmental levels. Health services costs for children with mental health conditions are estimated to be twice those for the average child. The Incredible Years® Parent Program (IY) has a strong evidence-base supporting its effectiveness in reducing early onset conduct problems. The overall objective of this stage 3 (T3) translational research proposal is to conduct a pilot study of 45 pediatrician-referred parents who participate in IY and examine the impact of IY on pHSU of their children. Pediatric HSU outcome measures include: all-cause ED visits; in-patient hospitalizations and length of stay; authorizations for specialist referrals; primary and acute care visits; and ED visits for mental health conditions. The investigator's central hypothesis is that children ages 3 to 6 years with behavior concerns whose parents are referred by their pediatricians for participation in IY will have decreased mean annual all-cause pHSU and decreased ED visits for mental health conditions in the 12 months following IY, compared to the 24 months prior to IY participation. This is important to demonstrate because significant financial barriers exist to integrating effective family focused prevention services like IY into pediatric primary care settings. Demonstration of reduced pHSU is one way to address these translational barriers. Results of this pilot study are expected to provide preliminary data on pre- and post-intervention effect sizes; these data will be used to demonstrate the feasibility of collecting data using existing sources of pHSU to design a more fully powered multi-site trial with a robust comparator group.

Eligibility criteria: Inclusion Criteria:

* Children receiving primary care at CHLA AltaMed with parent-reported behavioral concerns whose parents are referred by their pediatricians for participation in the Incredible Years Parenting Program.
* Continuous enrollment in AltaMed Medicaid funded health services during the 24 months prior to participation in IY and 12 months following participation in IY with lapses in coverage of no more than 90 days in length.
* Parents are English or Spanish-speaking or willing to use interpretation if they speak another language.

Exclusion Criteria:

* Private (commercial non-Medicaid) insurance coverage for greater than 90 days during the 24 months prior to participation in IY and 12 months following participation in IY.

Primary outcomes:
measure: Change in Annual Pediatric Health Services Utilization from 24 months prior to IY Parent Group Participation to 12 months following IY Parent Group Participation
timeFrame: Utilization for 24 months prior to intervention and 12 months following intervention
Secondary outcomes:
measure: Eyberg Child Behavior Inventory
timeFrame: During week before or after starting group; and during week before or after ending group, up to 20 weeks
measure: Youth Outcome Questionnaire (Parent Report)
timeFrame: During week before or after starting group; and during week before or after ending group, up to 20 weeks
measure: Pediatric Symptom Checklist
timeFrame: During week before or after starting group; and during week before or after ending group, up to 20 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: University of Southern California; Children's Hospital Los Angeles
name: DEAN M COFFEY, PsyD, MS
role: PRINCIPAL_INVESTIGATOR
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