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Clinical Trials/NCT03669289
NCT03669289
Completed
Not Applicable

Enhanced Support for Behavioral Barriers to Learning: An Evaluation of the SCHOOL STARS (Supporting Child Health Outcomes, Optimizing Learning, Striving to Achieve Real Solutions) Program

Children's Hospital Medical Center, Cincinnati1 site in 1 country14 target enrollmentSeptember 14, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disruptive Behavior Disorder, Childhood Onset
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
14
Locations
1
Primary Endpoint
Change in Child Behavior Checklist scores (externalizing subscale)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This small pilot study will enroll children ages 5-12 years of age with disruptive behavior problems at school. These children and their families will be offered an enhanced model of primary care, which includes pre-visit record review, standardized content of primary care visits, post-visit care coordination by the primary care team, and coordination of services between the primary care team and the school. We hypothesize that children receiving this enhanced model of care will achieve better behavioral outcomes at both school and home.

Registry
clinicaltrials.gov
Start Date
September 14, 2018
End Date
April 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Student at a local public school
  • Primary care patient at the Pediatric Primary Care Center (PPC) at CCHMC, or a CCHMC-affiliated school-based health center
  • School disciplinary problems defined as: (1) any suspension from school within the last 2 school months and/or (2) frequent calls to the parent from school (1+ times per week x 1 month)
  • Parent is in the contemplative, preparation, or action stage of readiness for starting medication or therapy if recommended by a healthcare provider for their child's behavior problems
  • Student may or may not have an existing diagnosis of an externalizing behavioral health disorder, such as ADHD, Oppositional Defiant Disorder, or Disruptive Mood Dysregulation Disorder.

Exclusion Criteria

  • Non-English-speaking parent
  • Enrolled in another ADHD study
  • Severe developmental delay or autism
  • Potential cardiac contraindications to starting stimulant medications without an EKG (personal or family history of heart disease in a child, family history of sudden death before age 50, family history of death due to heart disease before age 50, personal history of seizures, personal history of unexplained syncopal episodes)
  • Patients who have an established relationship with a PPC Care Manager
  • Patients who have seen the same primary care provider for the last two well child or behavior-related visits (unless approved/referred by that primary care provider)

Outcomes

Primary Outcomes

Change in Child Behavior Checklist scores (externalizing subscale)

Time Frame: at enrollment and 3 months post-intervention

parent-completed assessment of child behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse

Secondary Outcomes

  • Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scores(all historical data and all data up to 3 months post-intervention)
  • Change in days of suspension from school(3 months pre-intervention and 3 months post-intervention)
  • Change in disciplinary referrals at school(3 months pre-intervention to 3 months post-intervention)
  • Change in calls to parent from school(3 months pre-intervention to 3 months post-intervention)

Study Sites (1)

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