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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03669289
Enrollment
14
Registered
2018-09-13
Start date
2018-09-14
Completion date
2019-04-30
Last updated
2019-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERenhanced 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.

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Pre-post within-subject design

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Child Behavior Checklist scores (externalizing subscale)at enrollment and 3 months post-interventionparent-completed assessment of child behavior; T scores for the externalizing subscale range 0-100 with higher scores being worse

Secondary

MeasureTime frameDescription
Change in disciplinary referrals at school3 months pre-intervention to 3 months post-interventionnumber of times per week child was referred for disciplinary action at school
Change in calls to parent from school3 months pre-intervention to 3 months post-interventionnumber of calls per week to the parent from school about the child's behavior
Change in days of suspension from school3 months pre-intervention and 3 months post-interventionnumber of days child was suspended from school
Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scoresall 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

MeasureTime frameDescription
Referral adherencefrom enrollment to 3 months post interventionpercentage of referrals to behavioral therapy that result in a completed appointment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026