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

Primary Purpose

Disruptive Behavior Disorder, Childhood Onset, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder in Children

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

enhanced model of primary care

About this trial

This is an interventional health services research trial for Disruptive Behavior Disorder, Childhood Onset

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept 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)

Sites / Locations

Cincinnati Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enhanced model of primary care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in disciplinary referrals at school

number of times per week child was referred for disciplinary action at school

Change in calls to parent from school

number of calls per week to the parent from school about the child's behavior

Change in days of suspension from school

number of days child was suspended from school

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

Full Information

NCT ID

NCT03669289

First Posted

August 31, 2018

Last Updated

May 20, 2019

Sponsor

Children's Hospital Medical Center, Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT03669289

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

September 14, 2018 (Actual)

Primary Completion Date

April 30, 2019 (Actual)

Study Completion Date

April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Disruptive Behavior Disorder, Childhood Onset, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder in Children, Disruptive Mood Dysregulation Disorder

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pre-post within-subject design

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enhanced model of primary care

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

enhanced model of primary care

Other Intervention Name(s)

SCHOOL STARS care model

Intervention Description

The SCHOOL STARS model of care includes pre-visit planning, standardized visit content, post-visit care coordination, and coordination between primary care and school.

Primary Outcome Measure Information:

Title

Change in Child Behavior Checklist scores (externalizing subscale)

Description

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

Time Frame

at enrollment and 3 months post-intervention

Secondary Outcome Measure Information:

Title

Change in disciplinary referrals at school

Description

number of times per week child was referred for disciplinary action at school

Time Frame

3 months pre-intervention to 3 months post-intervention

Title

Change in calls to parent from school

Description

number of calls per week to the parent from school about the child's behavior

Time Frame

3 months pre-intervention to 3 months post-intervention

Title

Change in days of suspension from school

Description

number of days child was suspended from school

Time Frame

3 months pre-intervention and 3 months post-intervention

Title

Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scores

Description

(for participants with ADHD); Total Symptoms Score for items 1-18 (inattentive and hyperactive symptoms); Range 0-54; Higher scores represent a worse outcome

Time Frame

all historical data and all data up to 3 months post-intervention

Other Pre-specified Outcome Measures:

Title

Referral adherence

Description

percentage of referrals to behavioral therapy that result in a completed appointment

Time Frame

from enrollment to 3 months post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Courtney M Brown, MD

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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