ADHD
Conditions
Keywords
Behavioral intervention
Brief summary
Though the most effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD) consists of combined medication and behavioral strategies, the vast majority of children with ADHD are treated with medication only. One reason for the low rates of behavioral treatment is that primary care pediatricians, not mental health professionals, are responsible for treating the vast majority of children with ADHD. The investigators have developed, tested, and are beginning to disseminate web-based software (mehealth for ADHD) that has been shown in randomized clinical trials to improve the quality of ADHD medication care delivered by pediatricians. The goal of the proposed study is to develop and test the integration of behavioral tools into the evidence-based myadhdportal.com software in order to improve access to behavioral treatment strategies, and ultimately improve outcomes for children with ADHD. The automated algorithms and decision rules the investigators have developed for creating and monitoring the behavioral tools ensure that behavioral treatments like daily report cards and token economies are delivered in a manner that is consistent with the evidence-base. The investigators are conducting a cluster randomized controlled trial in community pediatric settings to test whether integration of the behavioral tools into the myADHDportal.com software (1) increases rates of behavioral treatment; (2) facilitates better integrity of behavioral interventions when implemented; (3) improves functional impairment in children with ADHD; and (4) generates higher satisfaction with ADHD care. By continuing to expand the functionality of the myADHDportal.com software, the investigators are increasing patients' access to evidence-based care. This is especially critical for rural and underserved communities who have no or limited access to evidence-based mental health services. Moreover, by putting these behavioral tools in the hands of parents, teachers, and pediatricians, the investigators are making it more likely that children will receive a high quality of care that includes both medication management and behavioral strategies, thereby improving the overall treatment outcomes of children with ADHD.
Interventions
Integrated functionality within the mehealth for ADHD software allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. Automated wizards lead parents and teachers through the process of selecting target behaviors and setting up reward schedules. Baseline data is gathered online and algorithms derive a set of behavioral goals for the child. Thereafter, parents or teachers record the child's performance directly into the software. Once behavioral monitoring begins, parents and teachers receive daily email or text communications from mehealth for ADHD alerting them to the daily rewards earned by their child. Finally, online algorithms exist that detect how a child is doing in meeting behavioral goals and prompt users to modify goals accordingly.
OTHERmehealth for ADHD
The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) a communication feature that allows parents, teachers, and pediatricians to communicate with each other; 6) an online pediatrician report card; and 7) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* child in grades K-5 * child has been diagnosed with ADHD by pediatrician or other mental health professional * child's ADHD care is currently being managed by pediatrician * if child is being prescribed ADHD medication, is currently on a stable dosage of medication * child is experiencing impairment at school as evidenced by a rating of 3 or higher on parent- or teacher-ratings of academic progress or problems in classroom and on the Impairment Rating Scale.
Exclusion criteria
* parent does not have access to a computer or smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Behavioral Treatment | 12 months after randomization | Parent-report of implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Rating of School Performance on Impairment Rating Scale | 6 months after randomization | Parent rating of child's impairment on School Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). |
| Teacher Rating of Academic Performance on Impairment Rating Scale | 6 months after randomization | Teacher rating of child's impairment on Academic Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). |
| Teacher Rating of Classroom Performance on Impairment Rating Scale | 6 months after randomization | Teacher rating of child's impairment on Classroom Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mehealth Portal With Integrated Behavioral Tools Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts | 85 |
| Mehealth Portal With no Integrated Behavioral Tools Patients in this arm will wait one year before getting access to the behavioral intervention features. | 84 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 8 |
| Overall Study | Withdrawal by Subject | 16 | 1 |
Baseline characteristics
| Characteristic | Mehealth Portal With no Integrated Behavioral Tools | Total | Mehealth Portal With Integrated Behavioral Tools |
|---|---|---|---|
| Age, Categorical <=18 years | 84 Participants | 169 Participants | 85 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.95 years STANDARD_DEVIATION 1.71 | 9.09 years STANDARD_DEVIATION 1.69 | 9.23 years STANDARD_DEVIATION 1.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 81 Participants | 164 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Parent rating of School Performance on Impairment Rating Scale | 3.64 units on a scale STANDARD_DEVIATION 1.73 | 3.46 units on a scale STANDARD_DEVIATION 0.179 | 3.27 units on a scale STANDARD_DEVIATION 1.85 |
| Parent-report of child receiving behavioral treatment at home or school | 66 participants | 136 participants | 70 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 140 Participants | 71 Participants |
| Region of Enrollment United States | 84 participants | 169 participants | 85 participants |
| Sex: Female, Male Female | 29 Participants | 53 Participants | 24 Participants |
| Sex: Female, Male Male | 55 Participants | 116 Participants | 61 Participants |
| Teacher rating of Academic Performance on Impairment Rating Scale | 3.45 units on a scale STANDARD_DEVIATION 1.69 | 3.30 units on a scale STANDARD_DEVIATION 1.79 | 3.15 units on a scale STANDARD_DEVIATION 1.79 |
| Teacher rating of Classroom Performance on Impairment Rating Scale | 2.55 units on a scale STANDARD_DEVIATION 1.95 | 2.60 units on a scale STANDARD_DEVIATION 1.85 | 2.66 units on a scale STANDARD_DEVIATION 1.76 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 84 |
| other Total, other adverse events | 0 / 85 | 0 / 84 |
| serious Total, serious adverse events | 0 / 85 | 0 / 84 |
Outcome results
Primary
Rates of Behavioral Treatment
Parent-report of implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview
Time frame: 12 months after randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mehealth Portal With Integrated Behavioral Tools | Rates of Behavioral Treatment | 44 Participants |
| Mehealth Portal With no Integrated Behavioral Tools | Rates of Behavioral Treatment | 64 Participants |
p-value: 0.535Chi-squared
Secondary
Parent Rating of School Performance on Impairment Rating Scale
Parent rating of child's impairment on School Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment).
Time frame: 6 months after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mehealth Portal With Integrated Behavioral Tools | Parent Rating of School Performance on Impairment Rating Scale | 3.14 units on a scale | Standard Deviation 1.65 |
| Mehealth Portal With no Integrated Behavioral Tools | Parent Rating of School Performance on Impairment Rating Scale | 3.50 units on a scale | Standard Deviation 1.48 |
p-value: 0.829ANOVA
Secondary
Teacher Rating of Academic Performance on Impairment Rating Scale
Teacher rating of child's impairment on Academic Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment).
Time frame: 6 months after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mehealth Portal With Integrated Behavioral Tools | Teacher Rating of Academic Performance on Impairment Rating Scale | 2.87 units on a scale | Standard Deviation 1.95 |
| Mehealth Portal With no Integrated Behavioral Tools | Teacher Rating of Academic Performance on Impairment Rating Scale | 3.38 units on a scale | Standard Deviation 1.69 |
p-value: 0.357ANOVA
Secondary
Teacher Rating of Classroom Performance on Impairment Rating Scale
Teacher rating of child's impairment on Classroom Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment).
Time frame: 6 months after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mehealth Portal With Integrated Behavioral Tools | Teacher Rating of Classroom Performance on Impairment Rating Scale | 2.27 units on a scale | Standard Deviation 1.82 |
| Mehealth Portal With no Integrated Behavioral Tools | Teacher Rating of Classroom Performance on Impairment Rating Scale | 2.21 units on a scale | Standard Deviation 1.78 |
p-value: 0.782ANOVA