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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03669289
Other study ID # CIN001-SCHOOLSTARS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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