NCT03704974

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

3.9 years

First QC Date

July 2, 2018

Last Update Submit

November 5, 2024

Conditions

Keywords

Child Health ServicesPediatric Health Service UtilizationIncredible Years

Outcome Measures

Primary Outcomes (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

    (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.

    Utilization for 24 months prior to intervention and 12 months following intervention

Secondary Outcomes (3)

  • Eyberg Child Behavior Inventory

    During week before or after starting group; and during week before or after ending group, up to 20 weeks

  • Youth Outcome Questionnaire (Parent Report)

    During week before or after starting group; and during week before or after ending group, up to 20 weeks

  • Pediatric Symptom Checklist

    During week before or after starting group; and during week before or after ending group, up to 20 weeks

Study Arms (1)

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

Interventions

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.

Also known as: Incredible Years® Preschool BASIC Parenting Program, Incredible Years® Early Childhood BASIC Parenting Program
Children of Parents Receiving IY

Eligibility Criteria

Age36 Months - 83 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

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Related Links

Study Officials

  • DEAN M COFFEY, PsyD, MS

    University of Southern California; Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2018

First Posted

October 15, 2018

Study Start

August 16, 2018

Primary Completion

June 22, 2022

Study Completion

June 22, 2022

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

No current plan approved by our Institutional Review Board (IRB) for sharing individual participant data.

Locations