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

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669289
• Other study ID #: CIN001-SCHOOLSTARS
• Status: Completed
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Disruptive Behavior Disorder, Childhood Onset
• Disruptive Mood Dysregulation Disorder
• Mental Disorders
• Oppositional Defiant Disorder in Children
• Problem Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Referral adherence	percentage of referrals to behavioral therapy that result in a completed appointment	from enrollment to 3 months post intervention
Primary	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	Change in disciplinary referrals at school	number of times per week child was referred for disciplinary action at school	3 months pre-intervention to 3 months post-intervention
Secondary	Change in calls to parent from school	number of calls per week to the parent from school about the child's behavior	3 months pre-intervention to 3 months post-intervention
Secondary	Change in days of suspension from school	number of days child was suspended from school	3 months pre-intervention and 3 months post-intervention
Secondary	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	all historical data and all data up to 3 months post-intervention