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The Impact of Parent Training on the Child's Health Services

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03704974
Recruitment Status : Enrolling by invitation
First Posted : October 15, 2018
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
AltaMed Health Services
Information provided by (Responsible Party):
Children's Hospital Los Angeles

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Parenting Child Rearing Child Behavior Problem Behavioral: Video-Based Parent Training 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Impact of Evidence-Based Parent Training on Pediatric Health Services Utilization
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Children of Parents Receiving IY
Children ages 3 to 6 years at start of group with behavior concerns whose parents are referred by their pediatricians for participation in a video-based parent training program from 2014 through 2018.
 Behavioral: Video-Based Parent Training Program
An18-20 week evidence-based social cognitive theory-based parenting program where parents see brief video vignettes of effective and less effective parenting and develop concepts to modify their child's behavior.
Other Names:
  • Incredible Years® Preschool BASIC Parenting Program
  • Incredible Years® Early Childhood BASIC Parenting Program


Outcome Measures
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Primary Outcome Measures :
  1. Change in Annual Pediatric Health Services Utilization from 24 months prior to IY Parent Group Participation to 12 months following IY Parent Group Participation [ Time Frame: Utilization for 24 months prior to intervention and 12 months following intervention ]
    (1) all-cause Emergency Department (ED) visits (yes/no) and number; (2) ED visits for mental health conditions (yes/no) and number; (3) in-patient hospitalizations (yes/no) and number, and length of stay in days; (4) authorizations for specialist referrals from AltaMed (yes/no) and number; (5) number of AltaMed primary care visits; (6) AltaMed acute care visits (yes/no) and number; (7) AltaMed mental health visits (yes/no) and number; (8) Children's Hospital Los Angeles (CHLA) specialty mental health visits (yes/no) and number.


Secondary Outcome Measures :
  1. Eyberg Child Behavior Inventory [ Time Frame: During week before or after starting group; and during week before or after ending group, up to 20 weeks ]
    Raw and T-scores for Intensity [measures frequency of problem behaviors; range 36 to 252; higher worse] and Problem [measures number of behaviors that are a problem for the parent; range 0 to 36; higher worse] Subscales

  2. Youth Outcome Questionnaire (Parent Report) [ Time Frame: During week before or after starting group; and during week before or after ending group, up to 20 weeks ]
    Total raw score [measures change in frequency of child symptoms and prosocial behaviors; range -16 to 240; higher worse].

  3. Pediatric Symptom Checklist [ Time Frame: During week before or after starting group; and during week before or after ending group, up to 20 weeks ]
    Total raw score [measures frequency of pediatric psychosocial problems; range 0 to 70; higher worse].


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 83 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704974


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Children's Hospital Los Angeles
AltaMed Health Services
Investigators
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Principal Investigator: DEAN M COFFEY, PsyD University of Southern California; Children's Hospital Los Angeles
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:
General US. Mental health: A report of the surgeon general. Rockville, MD: US Department of Health and Human Services. Substance Abuse and Mental Health Services Administration, Center for Mental Health Services, National Institutes of Health, National Institute of Mental Health. 1999.
US Department of Health and Human Services. The national survey of children's health 2007. US Department of Health and Human Services, Health Resources and Service Administration, Maternal and Child Health Bureau, Rockville, MD. 2009.
Webster-Stratton, C. The Incredible Years®: parents, teachers and children training series. Leader's guide: Preschool version of BASIC. 2008. Seattle, WA
Soni, Anita. The Five Most Costly Children's Conditions, 2006: Estimates for the U.S. Civilian Noninstitutionalized Children, Ages 0-17. Statistical Brief #242. April 2009. Agency for Healthcare Research and Quality, Rockville, MD. . http://www.meps.ahrq.gov/mepsweb/data_files/publications/st242/stat242.shtml
Kershaw P, Irwin L, Trafford K, Hertzman C. The British Columbia atlas of child development (Vol. 40). Vancouver, BC: Human Early Learning Partnership; 2005.
Eyberg SM, Pincus D. Eyberg child behavior inventory and sutter-eyberg student behavior inventory-revised: Professional manual. Psychological Assessment Resources; 1999.
Wells MG, Burlingame GM, Lambert MJ, Hoag MJ, Hope CA. Conceptualization and measurement of patient change during psychotherapy: Development of the Outcome Questionnaire and Youth Outcome Questionnaire. Psychotherapy: Theory, Research, Practice, Training. 1996;33(2):275. doi:10.1037/0033-3204.33.2.275

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Responsible Party: Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT03704974    
Other Study ID Numbers: CHLA-17-00001
UL1TR001855 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No current plan approved by our Institutional Review Board (IRB) for sharing individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Los Angeles:
Child Health Services
Pediatric Health Service Utilization
Incredible Years
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms