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

NCT03669289 | Completed

• 1 other identifier: CIN001-SCHOOLSTARS
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in disciplinary referrals at school

  3 months pre-intervention to 3 months post-intervention

• Change in calls to parent from school

  3 months pre-intervention to 3 months post-intervention

• Change in days of suspension from school

  3 months pre-intervention and 3 months post-intervention

• Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scores

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

Other Outcomes (1)

• Referral adherence

  from enrollment to 3 months post intervention

Study Arms (1)

Enhanced model of primary care

EXPERIMENTAL

Other: enhanced model of primary care

Interventions

enhanced model of primary care OTHER

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

Also known as: SCHOOL STARS care model

Enhanced model of primary care

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Courtney M Brown, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post within-subject design

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 13, 2018
• Study Start: September 14, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)