ADHD
Conditions
Brief summary
ADHD is the most prevalent mental health disorder of childhood. The majority of children with ADHD receive their care in primary care settings. While the American Academy of Pediatrics (AAP) issued evidence-based guidelines and recommendations for pediatricians, most pediatricians have difficulty adhering to these guidelines. Given observed deficiencies in evidence-based ADHD care and the likely effects on child outcomes, the development and testing of interventions aimed at improving ADHD care in primary care settings is necessary. Cincinnati Children's Hospital Medical Center has developed a model intervention, termed the ADHD Collaborative, to comprehensively address this issue. The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines. This intervention model has been used to train over 200 physicians at 55 practices in the Greater Cincinnati area. The intervention appears to produce 2- to 4-fold increases in the use of evidence-based ADHD-related practice behaviors in participating physicians. To date, the intervention has been implemented as a quality improvement project with few experimental controls. The primary goal of the proposed study is to conduct an experimentally-controlled cluster randomized trial of the ADHD Collaborative intervention. Thirty-two pediatric practices will be randomly assigned to receive the ADHD Collaborative intervention or to provide usual care. Approximately 96 physicians and 576 of their ADHD patients will be included in the study. Chart reviews, parental interviews, and parent and teacher rating scales will be collected. Between- and within-group hierarchical linear modeling analyses will examine whether the intervention produces significant improvements in pediatrician practice behaviors, patient satisfaction with ADHD care, and child outcomes over and above typical ADHD care. Also, the relative cost effectiveness of the ADHD Collaborative intervention over typical care will be established by computing incremental cost-effectiveness ratios using cost and effect size estimates.
Interventions
OTHERADHD Collaborative
The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines.
Sponsors
Nationwide Children's Hospital
National Institute of Mental Health (NIMH)
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Practice must have a minimum of two pediatricians who agree to participate. * Practice must have an electronic billing system. * Practice must have internet access at office. * Practice must not have an on-site mental health professional. * Practice must have a member of practice staff willing to be trained in human subjects certification and willing to consent families. * Children must be in Grade 1-5. * Children must be newly diagnosed with ADHD.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent-rated ADHD Symptoms | 12 months | Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation. |
| Teacher-rated ADHD Symptoms | 12 months | Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADHD Collaborative Intervention The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.
ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines. | 258 |
| Typical ADHD Care Physicians in this group will provide typical ADHD care. | 319 |
| Total | 577 |
Baseline characteristics
| Characteristic | ADHD Collaborative Intervention | Total | Typical ADHD Care |
|---|---|---|---|
| Age, Continuous | 7.9 Years STANDARD_DEVIATION 1.5 | 7.8 Years STANDARD_DEVIATION 1.4 | 7.8 Years STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 13 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 252 Participants | 564 Participants | 312 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 123 Participants | 90 Participants |
| Race (NIH/OMB) More than one race | 36 Participants | 71 Participants | 35 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 187 Participants | 378 Participants | 191 Participants |
| Region of Enrollment United States | 258 participants | 577 participants | 319 participants |
| Sex: Female, Male Female | 79 Participants | 170 Participants | 91 Participants |
| Sex: Female, Male Male | 179 Participants | 407 Participants | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 258 | 0 / 319 |
| serious Total, serious adverse events | 0 / 258 | 0 / 319 |
Outcome results
Primary
Parent-rated ADHD Symptoms
Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.
Time frame: 12 months
Population: Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADHD Collaborative Intervention | Parent-rated ADHD Symptoms | 20.5 scores on a scale | Standard Deviation 9 |
| Typical ADHD Care | Parent-rated ADHD Symptoms | 24.1 scores on a scale | Standard Deviation 9.4 |
Comparison: Utilizing the full sample (n=577), an intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.p-value: <0.0595% CI: [-5.89, -1.19]Mixed Models Analysis
Primary
Teacher-rated ADHD Symptoms
Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.
Time frame: 12 months
Population: Analyses only included patients who had a post-intervention teacher-rated ADHD scale. Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADHD Collaborative Intervention | Teacher-rated ADHD Symptoms | 19.0 scores on a scale | Standard Deviation 9.9 |
| Typical ADHD Care | Teacher-rated ADHD Symptoms | 20.4 scores on a scale | Standard Deviation 11.1 |
Comparison: An intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.p-value: <0.0595% CI: [-4.71, 1.75]Mixed Models Analysis