New Technologies to Help Manage ADHD

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT02390791
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 85
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Other: enhanced myADHDportal.com; Other: treatment as usual standard portal	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Health Services Research
• Official Title: Developing New Technologies to Improve ADHD Medication Continuity
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: 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
Active Comparator: treatment as usual standard portal Standard version of myADHDportal.com web software	Other: treatment as usual standard portal; Standard version of myADHDportal.com web software

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. 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)

4. Working Alliance Inventory [6 months after starting treatment]

   range 12-60, higher scores better (more alliance)

5. 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)

6. 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)

7. 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

8. Total Number of myADHDportal.Com Log-ins by Parent [6 months after starting treatment]

9. Total Number of Measures Completed by Parents to Track Child Response to Treatment [6 months after starting treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	William B Brinkman	Cincinnati	Ohio	United States	45237

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: William Brinkman, MD, MEd, MSc, Cincinnati Children's

Study Documents (Full-Text)

• Study Protocol - Jun 19, 2017
• Statistical Analysis Plan - Nov 1, 2017

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT02390791
• Other Study ID Numbers: R34MH101155; R34MH101155
• First Posted: Mar 18, 2015
• Last Update Posted: Sep 13, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Attention Deficit Disorder with Hyperactivity

Study Results

Participant Flow

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Period Title: Overall Study
STARTED	40	45
COMPLETED	40	45
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal	Total
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software	Total of all reporting groups
Overall Participants	40	45	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.88 (1.34)	7.96 (1.23)	7.92 (1.28)
Sex: Female, Male (Count of Participants)
Female	12 30%	11 24.4%	23 27.1%
Male	28 70%	34 75.6%	62 72.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 7.5%	5 11.1%	8 9.4%
Not Hispanic or Latino	37 92.5%	39 86.7%	76 89.4%
Unknown or Not Reported	0 0%	1 2.2%	1 1.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2.5%	0 0%	1 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	1 2.2%	1 1.2%
Black or African American	7 17.5%	6 13.3%	13 15.3%
White	30 75%	33 73.3%	63 74.1%
More than one race	2 5%	3 6.7%	5 5.9%
Unknown or Not Reported	0 0%	2 4.4%	2 2.4%

Outcome Measures

1. Primary Outcome

Title	Medication Continuity: The Number of Days Covered With Medicine
Description	the number of days covered with medicine will be calculated from audit of prescriptions written
Time Frame	first 6 months of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	40	45
Mean (Standard Deviation) [Days]	108.8 (45.8)	133.3 (50.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	generalized linear model
	Comments	assuming a Poisson distribution with a log link function

2. Secondary Outcome

Title	Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale)
Description	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

Outcome Measure Data

Analysis Population Description

population who completed this outcome assessment

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	23	24
Median (Inter-Quartile Range) [score on a scale]	0.44	-0.06

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Parent-reported Decisional Conflict (Decisional Conflict Scale)
Description	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

Outcome Measure Data

Analysis Population Description

population who completed this outcome assessment

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	23	25
Median (Inter-Quartile Range) [score on a scale]	14.06	20.31

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Parent Trust in Provider (Trust in Provider Scale)
Description	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

Outcome Measure Data

Analysis Population Description

population who completed this outcome assessment

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	23	24
Median (Inter-Quartile Range) [score on a scale]	45.0	41.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Working Alliance Inventory
Description	range 12-60, higher scores better (more alliance)
Time Frame	6 months after starting treatment

Outcome Measure Data

Analysis Population Description

population who completed this outcome assessment

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	23	24
Median (Inter-Quartile Range) [score on a scale]	50.0	46.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Parent Perceived Social Support (Perceived Social Support Scale)
Description	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

Outcome Measure Data

Analysis Population Description

population who completed this outcome assessment

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	23	24
Median (Inter-Quartile Range) [score on a scale]	54.00	68.95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Parent Distress (Parenting Stress Index - Short Form)
Description	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

Outcome Measure Data

Analysis Population Description

population who completed this outcome assessment

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	22	23
Median (Inter-Quartile Range) [score on a scale]	75.57	74.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale
Description	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

Outcome Measure Data

Analysis Population Description

population who completed this outcome assessment

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	23	25
Count of Participants [Participants]	13 32.5%	9 20%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	Chi-squared
	Comments

9. Secondary Outcome

Title	Total Number of myADHDportal.Com Log-ins by Parent
Time Frame	6 months after starting treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	40	45
Mean (Standard Deviation) [logins]	11.33 (13.84)	8.47 (7.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.48
	Comments
	Method	generalized linear model
	Comments

10. Secondary Outcome

Title	Total Number of Measures Completed by Parents to Track Child Response to Treatment
Time Frame	6 months after starting treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enhanced myADHDportal.Com	Treatment as Usual Standard Portal
Arm/Group Description	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	Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
Measure Participants	40	45
Mean (Standard Deviation) [measures]	2.50 (3.37)	2.31 (3.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Enhanced myADHDportal.Com, Treatment as Usual Standard Portal
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	generalized linear model
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Enhanced myADHDportal.Com		Treatment as Usual Standard Portal
Arm/Group Description	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		Standard version of myADHDportal.com web software treatment as usual standard portal: Standard version of myADHDportal.com web software
All Cause Mortality
	Enhanced myADHDportal.Com		Treatment as Usual Standard Portal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/45 (0%)
Serious Adverse Events
	Enhanced myADHDportal.Com		Treatment as Usual Standard Portal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Enhanced myADHDportal.Com		Treatment as Usual Standard Portal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.