Clinical trial NCT03669289: 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
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Behavior Disorder, Childhood Onset
Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder in Children
Disruptive Mood Dysregulation Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post within-subject design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Change in Child Behavior Checklist scores (externalizing subscale)
timeFrame: at enrollment and 3 months post-intervention
Secondary outcomes:
measure: Change in disciplinary referrals at school
timeFrame: 3 months pre-intervention to 3 months post-intervention
measure: Change in calls to parent from school
timeFrame: 3 months pre-intervention to 3 months post-intervention
measure: Change in days of suspension from school
timeFrame: 3 months pre-intervention and 3 months post-intervention
measure: Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scores
timeFrame: all historical data and all data up to 3 months post-intervention
Other outcomes:
measure: Referral adherence
timeFrame: from enrollment to 3 months post intervention
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Courtney M Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: