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

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT03669289

Collaborator

(none)

Enrollment

Location

Arm

7.5

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disruptive Behavior Disorder, Childhood Onset Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder in Children Disruptive Mood Dysregulation Disorder	Other: enhanced model of primary care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pre-post within-subject designPre-post within-subject design

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Sep 14, 2018

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Child Behavior Checklist scores (externalizing subscale) [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 Outcome Measures

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

Other Outcome Measures

Referral adherence [from enrollment to 3 months post intervention]
percentage of referrals to behavioral therapy that result in a completed appointment

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)