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Completed

NCT Number: NCT03669289

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

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.

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Key information

Conditions

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

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: SCHOOL STARS care model

Primary outcomes

  1. Change in Child Behavior Checklist scores (externalizing subscale)

    Time frame: 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 outcomes

  1. Change in disciplinary referrals at school

    Time frame: 3 months pre-intervention to 3 months post-intervention

    number of times per week child was referred for disciplinary action at school

  2. Change in calls to parent from school

    Time frame: 3 months pre-intervention to 3 months post-intervention

    number of calls per week to the parent from school about the child's behavior

  3. Change in days of suspension from school

    Time frame: 3 months pre-intervention and 3 months post-intervention

    number of days child was suspended from school

  4. Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scores

    Time frame: 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

Other outcomes

  1. Referral adherence

    Time frame: from enrollment to 3 months post intervention

    percentage of referrals to behavioral therapy that result in a completed appointment

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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