New Technologies to Help Manage ADHD

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Other: treatment as usual standard portal; Other: enhanced myADHDportal.com

• Registration Number: NCT02390791
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-18
• Study Start: 2015-09
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2018-07-27
• Status Verified: 2019-08
• Results First Submitted QC: 2019-09-12
• Last Update Submitted: 2019-09-12
• Results First Posted: 2019-09-13
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment as usual standard portal	treatment as usual standard portal	Standard version of myADHDportal.com web software
enhanced myADHDportal.com	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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)
Working Alliance Inventory	6 months after starting treatment	range 12-60, higher scores better (more alliance)
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)
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)
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
Total Number of myADHDportal.Com Log-ins by Parent	6 months after starting treatment
Total Number of Measures Completed by Parents to Track Child Response to Treatment	6 months after starting treatment

Trial Locations

Locations (1)

William B Brinkman; 🇺🇸 Cincinnati, Ohio, United States