NCT02390791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 13, 2019

Completed
Last Updated

September 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

March 4, 2015

Results QC Date

July 27, 2018

Last Update Submit

September 12, 2019

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • Medication Continuity: The Number of Days Covered With Medicine

    the number of days covered with medicine will be calculated from audit of prescriptions written

    first 6 months of treatment

Secondary Outcomes (9)

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

    6 months after starting treatment

  • Parent-reported Decisional Conflict (Decisional Conflict Scale)

    6 months after starting treatment

  • Parent Trust in Provider (Trust in Provider Scale)

    6 months after starting treatment

  • Working Alliance Inventory

    6 months after starting treatment

  • Parent Perceived Social Support (Perceived Social Support Scale)

    6 months after starting treatment

  • +4 more secondary outcomes

Study Arms (2)

enhanced myADHDportal.com

EXPERIMENTAL

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

treatment as usual standard portal

ACTIVE COMPARATOR

Standard version of myADHDportal.com web software

Other: treatment as usual standard portal

Interventions

enhanced myADHDportal.comOTHER

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
treatment as usual standard portalOTHER

Standard version of myADHDportal.com web software

treatment as usual standard portal

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to read and speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William B Brinkman

Cincinnati, Ohio, 45237, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Dr. William B. Brinkman
Organization
Cincinnati Children's
bill.brinkman@cchmc.org
513-636-2576

Study Officials

  • William Brinkman, MD, MEd, MSc

    Cincinnati Children's

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 18, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 13, 2019

Results First Posted

September 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)