ClinicalTrials.gg
CompletedNCT03669289Updated May 22, 2019

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

An interventional study of enhanced model of primary care in Disruptive Behavior Disorder, Childhood Onset, Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder in Children, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-05-22.

Primary conditionAttention Deficit Disorder with HyperactivityRegistry: Attention Deficit and Disruptive Behavior DisordersReclassifiedWhy we changed it
Registry
Attention Deficit and Disruptive Behavior Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Attention Deficit Disorder with Hyperactivity
Why
  1. The study's listed conditions name Attention Deficit Disorder with Hyperactivity, a narrower term within Attention Deficit and Disruptive Behavior Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Health services research

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Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
5 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 36 studies in Attention Deficit Disorder with Hyperactivity by Children's Hospital Medical Center, Cincinnati — 4 open to participants now, 4 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · Children's Hospital Medical Center, Cincinnati.

Enrollment
32nd of 35
14 · median 49
Started
2018
with 4 others
No phase
24 of 36
3 open now
Registered
22nd of 36
by date

Among the 36 studies in Attention Deficit Disorder with Hyperactivity by Children's Hospital Medical Center, Cincinnati, this one is the 32nd largest by enrollment of the 35 interventional ones that give a count, is one of 5 that started in 2018, is one of 24 with no phase, and was the 22nd registered.

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 295 are open to participants now.

Browse Attention Deficit Disorder with Hyperactivity studies →

Open to participants now

4 of the 36 studies in Attention Deficit Disorder with Hyperactivity by Children's Hospital Medical Center, Cincinnati are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.

This study: 5 Years to 12 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 36 studies in Attention Deficit Disorder with Hyperactivity by Children's Hospital Medical Center, Cincinnati, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Disruptive Behavior Disorder, Childhood Onset
  • Attention Deficit Hyperactivity Disorder
  • Oppositional Defiant Disorder in Children
  • Disruptive Mood Dysregulation Disorder
04

In context

Attention Deficit Disorder with Hyperactivity Reclassified

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 295 are open to participants now.

This study's enrollment of 14 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 129 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.

Compared within Attention Deficit Disorder with Hyperactivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Attention Deficit and Disruptive Behavior Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Non-English-speaking parent
  • Enrolled in another ADHD study
  • Severe developmental delay or autism
  • Potential cardiac to starting stimulant medications without an (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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

06

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Enhanced model of primary care

    Other: enhanced model of primary care

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.

    Also known as: SCHOOL STARS care model

07

What researchers measure

Primary outcomes

  1. 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

    Time frame: at enrollment and 3 months post-intervention

Secondary outcomes

  1. Change in disciplinary referrals at school

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

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

  2. Change in calls to parent from school

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

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

  3. Change in days of suspension from school

    number of days child was suspended from school

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

  4. 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

    Time frame: all historical data and all data up to 3 months post-intervention

Other outcomes

  1. Referral adherence

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

    Time frame: from enrollment to 3 months post intervention

08

Study locations

1 site
  • Cincinnati Children's Hospital
    Cincinnati, Ohio 45229, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Apr 2019, 7 months.

Of 480 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 7 months is below that.

Counting every sponsor, half of 511 studies reached it within 23 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2018
First posted
Sep 13, 2018
StartActual
Sep 14, 2018
Primary completionActual
Apr 30, 2019
CompletionActual
Apr 30, 2019
Last update
May 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03669289
Responsible party
Sponsor
First posted
Sep 13, 2018
Start date
Sep 14, 2018
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019
Last update
May 22, 2019

Study contacts

Courtney M Brown, MD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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