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

Not Applicable

Completed

• Conditions: Oppositional Defiant Disorder in Children; Disruptive Mood Dysregulation Disorder; Disruptive Behavior Disorder, Childhood Onset; Attention Deficit Hyperactivity Disorder
• Interventions: Other: enhanced model of primary care

• Registration Number: NCT03669289
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Study Start: 2018-09-14
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced model of primary care	enhanced model of primary care	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States