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New Technologies to Help Manage ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
enhanced myADHDportal.com
treatment as usual standard portal
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • William B Brinkman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

enhanced myADHDportal.com

treatment as usual standard portal

Arm 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

Standard version of myADHDportal.com web software

Outcomes

Primary Outcome Measures

Medication Continuity: The Number of Days Covered With Medicine
the number of days covered with medicine will be calculated from audit of prescriptions written

Secondary Outcome Measures

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
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
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)
Working Alliance Inventory
range 12-60, higher scores better (more alliance)
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)
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)
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
Total Number of myADHDportal.Com Log-ins by Parent
Total Number of Measures Completed by Parents to Track Child Response to Treatment

Full Information

First Posted
March 4, 2015
Last Updated
September 12, 2019
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02390791
Brief Title
New Technologies to Help Manage ADHD
Official Title
Developing New Technologies to Improve ADHD Medication Continuity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enhanced myADHDportal.com
Arm Type
Experimental
Arm 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 Title
treatment as usual standard portal
Arm Type
Active Comparator
Arm Description
Standard version of myADHDportal.com web software
Intervention Type
Other
Intervention Name(s)
enhanced myADHDportal.com
Intervention 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
Intervention Type
Other
Intervention Name(s)
treatment as usual standard portal
Intervention Description
Standard version of myADHDportal.com web software
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
Title
Working Alliance Inventory
Description
range 12-60, higher scores better (more alliance)
Time Frame
6 months after starting treatment
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
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
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
Title
Total Number of myADHDportal.Com Log-ins by Parent
Time Frame
6 months after starting treatment
Title
Total Number of Measures Completed by Parents to Track Child Response to Treatment
Time Frame
6 months after starting treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parents of children are eligible to participate if their child receives ADHD care at one of the pediatric primary care practices that is partnering to conduct this trial child being registered on myADHDportal.com to initiate child assessment of ADHD child age 6-10 years child must not have been previously treated with ADHD medication child prescribed ADHD medication within 12 months of enrolling in the study Exclusion Criteria: Unable to read and speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Brinkman, MD, MEd, MSc
Organizational Affiliation
Cincinnati Children's
Official's Role
Principal Investigator
Facility Information:
Facility Name
William B Brinkman
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45237
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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