Enhanced Support for Behavioral Barriers to Learning: An Evaluation of the SCHOOL STARS Program

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder; Disruptive Mood Dysregulation Disorder; Oppositional Defiant Disorder in Children; Disruptive Behavior Disorder, Childhood Onset
• Intervention / Treatment: Other: enhanced model of primary care

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Enhanced model of primary care	Other: enhanced model of primary care; The SCHOOL STARS model of care includes pre-visit planning, standardized visit content, post-visit care coordination, and coordination between primary care and school.; Other Names: SCHOOL STARS care model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child Behavior Checklist scores (externalizing subscale)	parent-completed assessment of child behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse	at enrollment and 3 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in disciplinary referrals at school	number of times per week child was referred for disciplinary action at school	3 months pre-intervention to 3 months post-intervention
Change in calls to parent from school	number of calls per week to the parent from school about the child's behavior	3 months pre-intervention to 3 months post-intervention
Change in days of suspension from school	number of days child was suspended from school	3 months pre-intervention and 3 months post-intervention
Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scores	(for participants with ADHD); Total Symptoms Score for items 1-18 (inattentive and hyperactive symptoms); Range 0-54; Higher scores represent a worse outcome	all historical data and all data up to 3 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral adherence	percentage of referrals to behavioral therapy that result in a completed appointment	from enrollment to 3 months post intervention

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Courtney M Brown, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2018
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (ACTUAL): September 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 22, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Neurodevelopmental Disorders; Disease; Problem Behavior; Mental Disorders; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Child Behavior Disorders
• Other Study ID Numbers: CIN001-SCHOOLSTARS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No