Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
Cluster randomized controlled trial to evaluate the general effectiveness of intervention compared to control on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.
Detailed description
This cluster randomized controlled trial will evaluate the general effectiveness of the intervention (e.g. enhanced myADHDportal.com), compared to control (e.g. treatment as usual standard portal), on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.
Interventions
OTHERenhanced myADHDportal.com
Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child
OTHERtreatment as usual standard portal
Standard version of myADHDportal.com web software
Sponsors
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 10 Years
Healthy volunteers
No
Inclusion criteria
* Parents of children are eligible to participate if 1. their child receives ADHD care at one of the pediatric primary care practices that is partnering to conduct this trial 2. child being registered on myADHDportal.com to initiate child assessment of ADHD 3. child age 6-10 years 4. child must not have been previously treated with ADHD medication 5. child prescribed ADHD medication within 12 months of enrolling in the study
Exclusion criteria
* Unable to read and speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Continuity: The Number of Days Covered With Medicine | first 6 months of treatment | the number of days covered with medicine will be calculated from audit of prescriptions written |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent-reported Decisional Conflict (Decisional Conflict Scale) | 6 months after starting treatment | Total score calculated from parent-report on the Decisional Conflict Scale, range 0 to 100; higher scores are worse |
| Parent Trust in Provider (Trust in Provider Scale) | 6 months after starting treatment | Total score calculated from parent-report on the Trust in Provider Scale, range 10 to 50 with higher scores better (more trust) |
| Working Alliance Inventory | 6 months after starting treatment | range 12-60, higher scores better (more alliance) |
| Parent Perceived Social Support (Perceived Social Support Scale) | 6 months after starting treatment | Total score calculated from parent-report on the Perceived Social Support Scale, range 12-84, higher score better (more social support) |
| Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale) | 6 months after starting treatment | Necessity to concerns differential score, range -4 to 4, positive scores mean necessity outweighs concerns, negative scores mean that concerns outweigh beliefs about necessity |
| Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale | 6 months after starting treatment | Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale |
| Total Number of myADHDportal.Com Log-ins by Parent | 6 months after starting treatment | — |
| Total Number of Measures Completed by Parents to Track Child Response to Treatment | 6 months after starting treatment | — |
| Parent Distress (Parenting Stress Index - Short Form) | 6 months after starting treatment | Parental distress subscale score calculated from the Parenting Stress Index - Short Form; range 36-180, higher scores is worse (more stress) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced myADHDportal.Com Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child
enhanced myADHDportal.com: Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child | 40 |
| Treatment as Usual Standard Portal Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software | 45 |
| Total | 85 |
Baseline characteristics
| Characteristic | Treatment as Usual Standard Portal | Total | Enhanced myADHDportal.Com |
|---|---|---|---|
| Age, Continuous | 7.96 years STANDARD_DEVIATION 1.23 | 7.92 years STANDARD_DEVIATION 1.28 | 7.88 years STANDARD_DEVIATION 1.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 76 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 63 Participants | 30 Participants |
| Sex: Female, Male Female | 11 Participants | 23 Participants | 12 Participants |
| Sex: Female, Male Male | 34 Participants | 62 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 45 |
| other Total, other adverse events | 0 / 40 | 0 / 45 |
| serious Total, serious adverse events | 0 / 40 | 0 / 45 |
Outcome results
Primary
Medication Continuity: The Number of Days Covered With Medicine
the number of days covered with medicine will be calculated from audit of prescriptions written
Time frame: first 6 months of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced myADHDportal.Com | Medication Continuity: The Number of Days Covered With Medicine | 108.8 Days | Standard Deviation 45.8 |
| Treatment as Usual Standard Portal | Medication Continuity: The Number of Days Covered With Medicine | 133.3 Days | Standard Deviation 50.9 |
p-value: 0.04generalized linear model
Secondary
Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale
Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale
Time frame: 6 months after starting treatment
Population: population who completed this outcome assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced myADHDportal.Com | Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale | 13 Participants |
| Treatment as Usual Standard Portal | Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale | 9 Participants |
p-value: 0.15Chi-squared
Secondary
Parent Distress (Parenting Stress Index - Short Form)
Parental distress subscale score calculated from the Parenting Stress Index - Short Form; range 36-180, higher scores is worse (more stress)
Time frame: 6 months after starting treatment
Population: population who completed this outcome assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced myADHDportal.Com | Parent Distress (Parenting Stress Index - Short Form) | 75.57 score on a scale |
| Treatment as Usual Standard Portal | Parent Distress (Parenting Stress Index - Short Form) | 74.00 score on a scale |
p-value: 0.88Wilcoxon (Mann-Whitney)
Secondary
Parent Perceived Social Support (Perceived Social Support Scale)
Total score calculated from parent-report on the Perceived Social Support Scale, range 12-84, higher score better (more social support)
Time frame: 6 months after starting treatment
Population: population who completed this outcome assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced myADHDportal.Com | Parent Perceived Social Support (Perceived Social Support Scale) | 54.00 score on a scale |
| Treatment as Usual Standard Portal | Parent Perceived Social Support (Perceived Social Support Scale) | 68.95 score on a scale |
p-value: 0.94Wilcoxon (Mann-Whitney)
Secondary
Parent-reported Decisional Conflict (Decisional Conflict Scale)
Total score calculated from parent-report on the Decisional Conflict Scale, range 0 to 100; higher scores are worse
Time frame: 6 months after starting treatment
Population: population who completed this outcome assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced myADHDportal.Com | Parent-reported Decisional Conflict (Decisional Conflict Scale) | 14.06 score on a scale |
| Treatment as Usual Standard Portal | Parent-reported Decisional Conflict (Decisional Conflict Scale) | 20.31 score on a scale |
p-value: 0.85Wilcoxon (Mann-Whitney)
Secondary
Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale)
Necessity to concerns differential score, range -4 to 4, positive scores mean necessity outweighs concerns, negative scores mean that concerns outweigh beliefs about necessity
Time frame: 6 months after starting treatment
Population: population who completed this outcome assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced myADHDportal.Com | Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale) | 0.44 score on a scale |
| Treatment as Usual Standard Portal | Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale) | -0.06 score on a scale |
p-value: 0.89Wilcoxon (Mann-Whitney)
Secondary
Parent Trust in Provider (Trust in Provider Scale)
Total score calculated from parent-report on the Trust in Provider Scale, range 10 to 50 with higher scores better (more trust)
Time frame: 6 months after starting treatment
Population: population who completed this outcome assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced myADHDportal.Com | Parent Trust in Provider (Trust in Provider Scale) | 45.0 score on a scale |
| Treatment as Usual Standard Portal | Parent Trust in Provider (Trust in Provider Scale) | 41.5 score on a scale |
p-value: 0.69Wilcoxon (Mann-Whitney)
Secondary
Total Number of Measures Completed by Parents to Track Child Response to Treatment
Time frame: 6 months after starting treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced myADHDportal.Com | Total Number of Measures Completed by Parents to Track Child Response to Treatment | 2.50 measures | Standard Deviation 3.37 |
| Treatment as Usual Standard Portal | Total Number of Measures Completed by Parents to Track Child Response to Treatment | 2.31 measures | Standard Deviation 3 |
p-value: 0.71generalized linear model
Secondary
Total Number of myADHDportal.Com Log-ins by Parent
Time frame: 6 months after starting treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced myADHDportal.Com | Total Number of myADHDportal.Com Log-ins by Parent | 11.33 logins | Standard Deviation 13.84 |
| Treatment as Usual Standard Portal | Total Number of myADHDportal.Com Log-ins by Parent | 8.47 logins | Standard Deviation 7.53 |
p-value: 0.48generalized linear model
Secondary
Working Alliance Inventory
range 12-60, higher scores better (more alliance)
Time frame: 6 months after starting treatment
Population: population who completed this outcome assessment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced myADHDportal.Com | Working Alliance Inventory | 50.0 score on a scale |
| Treatment as Usual Standard Portal | Working Alliance Inventory | 46.0 score on a scale |
p-value: 0.13Wilcoxon (Mann-Whitney)