Trial Outcomes & Findings for New Technologies to Help Manage ADHD (NCT NCT02390791)
NCT ID: NCT02390791
Last Updated: 2019-09-13
Results Overview
the number of days covered with medicine will be calculated from audit of prescriptions written
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
first 6 months of treatment
Results posted on
2019-09-13
Participant Flow
Participant milestones
| Measure |
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
|
Treatment as Usual Standard Portal
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
45
|
|
Overall Study
COMPLETED
|
40
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
New Technologies to Help Manage ADHD
Baseline characteristics by cohort
| Measure |
Enhanced myADHDportal.Com
n=40 Participants
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
|
Treatment as Usual Standard Portal
n=45 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.88 years
STANDARD_DEVIATION 1.34 • n=99 Participants
|
7.96 years
STANDARD_DEVIATION 1.23 • n=107 Participants
|
7.92 years
STANDARD_DEVIATION 1.28 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: first 6 months of treatmentthe number of days covered with medicine will be calculated from audit of prescriptions written
Outcome measures
| Measure |
Enhanced myADHDportal.Com
n=40 Participants
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
|
Treatment as Usual Standard Portal
n=45 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Medication Continuity: The Number of Days Covered With Medicine
|
108.8 Days
Standard Deviation 45.8
|
133.3 Days
Standard Deviation 50.9
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentPopulation: population who completed this outcome assessment
Necessity to concerns differential score, range -4 to 4, positive scores mean necessity outweighs concerns, negative scores mean that concerns outweigh beliefs about necessity
Outcome measures
| Measure |
Enhanced myADHDportal.Com
n=23 Participants
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
|
Treatment as Usual Standard Portal
n=24 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale)
|
0.44 score on a scale
Interval -1.18 to 1.11
|
-0.06 score on a scale
Interval -0.52 to 0.86
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentPopulation: population who completed this outcome assessment
Total score calculated from parent-report on the Decisional Conflict Scale, range 0 to 100; higher scores are worse
Outcome measures
| Measure |
Enhanced myADHDportal.Com
n=23 Participants
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
|
Treatment as Usual Standard Portal
n=25 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Parent-reported Decisional Conflict (Decisional Conflict Scale)
|
14.06 score on a scale
Interval 6.25 to 29.69
|
20.31 score on a scale
Interval 14.06 to 26.56
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentPopulation: population who completed this outcome assessment
Total score calculated from parent-report on the Trust in Provider Scale, range 10 to 50 with higher scores better (more trust)
Outcome measures
| Measure |
Enhanced myADHDportal.Com
n=23 Participants
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
|
Treatment as Usual Standard Portal
n=24 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Parent Trust in Provider (Trust in Provider Scale)
|
45.0 score on a scale
Interval 38.0 to 48.0
|
41.5 score on a scale
Interval 39.0 to 46.5
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentPopulation: population who completed this outcome assessment
range 12-60, higher scores better (more alliance)
Outcome measures
| Measure |
Enhanced myADHDportal.Com
n=23 Participants
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
|
Treatment as Usual Standard Portal
n=24 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Working Alliance Inventory
|
50.0 score on a scale
Interval 44.0 to 55.0
|
46.0 score on a scale
Interval 44.0 to 49.5
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentPopulation: population who completed this outcome assessment
Total score calculated from parent-report on the Perceived Social Support Scale, range 12-84, higher score better (more social support)
Outcome measures
| Measure |
Enhanced myADHDportal.Com
n=23 Participants
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
|
Treatment as Usual Standard Portal
n=24 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Parent Perceived Social Support (Perceived Social Support Scale)
|
54.00 score on a scale
Interval 42.0 to 72.0
|
68.95 score on a scale
Interval 44.0 to 72.0
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentPopulation: population who completed this outcome assessment
Parental distress subscale score calculated from the Parenting Stress Index - Short Form; range 36-180, higher scores is worse (more stress)
Outcome measures
| Measure |
Enhanced myADHDportal.Com
n=22 Participants
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
|
Treatment as Usual Standard Portal
n=23 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Parent Distress (Parenting Stress Index - Short Form)
|
75.57 score on a scale
Interval 55.0 to 92.0
|
74.00 score on a scale
Interval 56.0 to 93.0
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentPopulation: population who completed this outcome assessment
Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale
Outcome measures
| Measure |
Enhanced myADHDportal.Com
n=23 Participants
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
|
Treatment as Usual Standard Portal
n=25 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale
|
13 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentOutcome measures
| Measure |
Enhanced myADHDportal.Com
n=40 Participants
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
|
Treatment as Usual Standard Portal
n=45 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Total Number of myADHDportal.Com Log-ins by Parent
|
11.33 logins
Standard Deviation 13.84
|
8.47 logins
Standard Deviation 7.53
|
SECONDARY outcome
Timeframe: 6 months after starting treatmentOutcome measures
| Measure |
Enhanced myADHDportal.Com
n=40 Participants
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
|
Treatment as Usual Standard Portal
n=45 Participants
Standard version of myADHDportal.com web software
treatment as usual standard portal: Standard version of myADHDportal.com web software
|
|---|---|---|
|
Total Number of Measures Completed by Parents to Track Child Response to Treatment
|
2.50 measures
Standard Deviation 3.37
|
2.31 measures
Standard Deviation 3.00
|
Adverse Events
Enhanced myADHDportal.Com
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual Standard Portal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place