Disruptive Behavior Disorder, Childhood OnsetNCT03669289
Enhanced Support for Behavioral Barriers to Learning: An Evaluation of the SCHOOL STARS Program
A study testing enhanced model of primary care in people with Disruptive Behavior Disorder, Childhood Onset and Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Disruptive Behavior Disorder, Childhood Onset, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder in Children
- What is being tested?
- enhanced model of primary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
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
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.
- Conditions
- Disruptive Behavior Disorder, Childhood Onset, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder in Children, Disruptive Mood Dysregulation Disorder
- Being tested
- enhanced model of primary care
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced model of primary careOther
Also called SCHOOL STARS care model
The SCHOOL STARS model of care includes pre-visit planning, standardized visit content, post-visit care coordination, and coordination between primary care and school.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced model of primary care | Experimental | Not described Receives: Other: enhanced model of primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at enrollment and 3 months post-intervention
Secondary outcomes (4)
Change in disciplinary referrals at school
number of times per week child was referred for disciplinary action at school
Measured: 3 months pre-intervention to 3 months post-intervention
Change in calls to parent from school
number of calls per week to the parent from school about the child's behavior
Measured: 3 months pre-intervention to 3 months post-intervention
Change in days of suspension from school
number of days child was suspended from school
Measured: 3 months pre-intervention and 3 months post-intervention
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
Measured: all historical data and all data up to 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start14 Sep 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Behavior Disorder, Childhood OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post within-subject design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Courtney M Brown, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669289
- Sponsor's protocol ID
- CIN001-SCHOOLSTARS
- Status last verified
- May 2019
- First submitted
- 31 Aug 2018
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03669289
- Acronym / sponsor ID
- CIN001-SCHOOLSTARS
- Conditions
- Disruptive Behavior Disorder, Childhood Onset, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder in Children, Disruptive Mood Dysregulation Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post within-subject design
| Arm | Type | Receives |
|---|---|---|
| Enhanced model of primary care | Experimental | Other: enhanced model of primary care |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced model of primary careAlso: SCHOOL STARS care modelThe SCHOOL STARS model of care includes pre-visit planning, standardized visit content, post-visit care coordination, and coordination between primary care and school. | Other | Enhanced model of primary care |
Primary outcome
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
4 secondary outcomes
Change in disciplinary referrals at school
Time frame: 3 months pre-intervention to 3 months post-intervention
Change in calls to parent from school
Time frame: 3 months pre-intervention to 3 months post-intervention
Change in days of suspension from school
Time frame: 3 months pre-intervention and 3 months post-intervention
Change in Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scale scores
Time frame: all historical data and all data up to 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Individual participant dataSharing planned: No
Related trials for Disruptive Behavior Disorder, Childhood Onset
Recruiting
Executive Function and Parenting in Childhood
Disruptive Behavior Disorder, Childhood Onset, Disruptive Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney M Brown, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced model of primary care in people with Disruptive Behavior Disorder, Childhood Onset and Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Behavior Checklist scores (externalizing subscale) (time frame: at enrollment and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.