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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669289
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-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 : September 14, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


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 Name: SCHOOL STARS care model




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in disciplinary referrals at school [ Time Frame: 3 months pre-intervention to 3 months post-intervention ]
    number of times per week child was referred for disciplinary action at school

  2. Change in calls to parent from school [ Time Frame: 3 months pre-intervention to 3 months post-intervention ]
    number of calls per week to the parent from school about the child's behavior

  3. Change in days of suspension from school [ Time Frame: 3 months pre-intervention and 3 months post-intervention ]
    number of days child was suspended from school

  4. Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scores [ Time Frame: 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:
  1. Referral adherence [ Time Frame: from enrollment to 3 months post intervention ]
    percentage of referrals to behavioral therapy that result in a completed appointment



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669289


Locations
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United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Courtney M Brown, MD Children's Hospital Medical Center, Cincinnati
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Informed Consent Form  [PDF] January 4, 2019

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03669289    
Other Study ID Numbers: CIN001-SCHOOLSTARS
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Behavioral Symptoms