Expired Study
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Cincinnati, Ohio 45237


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

R34MH101155


NCT ID:

NCT02390791


Secondary ID:

R34MH101155


Study Acronym:


Brief Title:

New Technologies to Help Manage ADHD


Official Title:

Developing New Technologies to Improve ADHD Medication Continuity


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

6 Years


Maximum Age:

10 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital Medical Center, Cincinnati


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

85


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:September 2015
Completion Date:August 2017
Completion Type:Actual
Primary Completion Date:August 2017
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:September 12, 2019
First Received Date:March 4, 2015
First Results Date:July 27, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Medication Continuity: The Number of Days Covered With Medicine
Time Frame:first 6 months of treatment
Safety Issues:False
Description:the number of days covered with medicine will be calculated from audit of prescriptions written
Outcome Type:Secondary Outcome
Measure:Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale)
Time Frame:6 months after starting treatment
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Parent-reported Decisional Conflict (Decisional Conflict Scale)
Time Frame:6 months after starting treatment
Safety Issues:False
Description:Total score calculated from parent-report on the Decisional Conflict Scale, range 0 to 100; higher scores are worse
Outcome Type:Secondary Outcome
Measure:Parent Trust in Provider (Trust in Provider Scale)
Time Frame:6 months after starting treatment
Safety Issues:False
Description:Total score calculated from parent-report on the Trust in Provider Scale, range 10 to 50 with higher scores better (more trust)
Outcome Type:Secondary Outcome
Measure:Working Alliance Inventory
Time Frame:6 months after starting treatment
Safety Issues:False
Description:range 12-60, higher scores better (more alliance)
Outcome Type:Secondary Outcome
Measure:Parent Perceived Social Support (Perceived Social Support Scale)
Time Frame:6 months after starting treatment
Safety Issues:False
Description:Total score calculated from parent-report on the Perceived Social Support Scale, range 12-84, higher score better (more social support)
Outcome Type:Secondary Outcome
Measure:Parent Distress (Parenting Stress Index - Short Form)
Time Frame:6 months after starting treatment
Safety Issues:False
Description:Parental distress subscale score calculated from the Parenting Stress Index - Short Form; range 36-180, higher scores is worse (more stress)
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description:Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale
Outcome Type:Secondary Outcome
Measure:Total Number of myADHDportal.Com Log-ins by Parent
Time Frame:6 months after starting treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Total Number of Measures Completed by Parents to Track Child Response to Treatment
Time Frame:6 months after starting treatment
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:enhanced myADHDportal.com
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
Arm Name:enhanced myADHDportal.com
Intervention Type:Other
Name:treatment as usual standard portal
Description:Standard version of myADHDportal.com web software
Arm Name:treatment as usual standard portal

Study Arms

Study Arm Type:Experimental
Arm Name:enhanced myADHDportal.com
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
Study Arm Type:Active Comparator
Arm Name:treatment as usual standard portal
Description:Standard version of myADHDportal.com web software

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Medical Center, Cincinnati
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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