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Completed

NCT Number: NCT02390791

New Technologies to Help Manage ADHD

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

William B Brinkman

Cincinnati, Ohio, 45237, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enhanced myADHDportal.com

Other

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

Other

Standard version of myADHDportal.com web software

Primary outcomes

  1. Medication Continuity: The Number of Days Covered With Medicine

    Time frame: first 6 months of treatment

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

Secondary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 6 months after starting treatment

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

  5. Parent Perceived Social Support (Perceived Social Support Scale)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 6 months after starting treatment

  9. Total Number of Measures Completed by Parents to Track Child Response to Treatment

    Time frame: 6 months after starting treatment

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Developing New Technologies to Improve ADHD Medication Continuity

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2015
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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