Clinical trial NCT02390791: New Technologies to Help Manage ADHD
Official title: Developing New Technologies to Improve ADHD Medication Continuity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-03-18
Enrollment: 85
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Medication Continuity: The Number of Days Covered With Medicine
timeFrame: first 6 months of treatment
Secondary outcomes:
measure: Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale)
timeFrame: 6 months after starting treatment
measure: Parent-reported Decisional Conflict (Decisional Conflict Scale)
timeFrame: 6 months after starting treatment
measure: Parent Trust in Provider (Trust in Provider Scale)
timeFrame: 6 months after starting treatment
measure: Working Alliance Inventory
timeFrame: 6 months after starting treatment
measure: Parent Perceived Social Support (Perceived Social Support Scale)
timeFrame: 6 months after starting treatment
measure: Parent Distress (Parenting Stress Index - Short Form)
timeFrame: 6 months after starting treatment
measure: Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale
timeFrame: 6 months after starting treatment
measure: Total Number of myADHDportal.Com Log-ins by Parent
timeFrame: 6 months after starting treatment
measure: Total Number of Measures Completed by Parents to Track Child Response to Treatment
timeFrame: 6 months after starting treatment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: William B Brinkman
state: Ohio
Study officials:
affiliation: Cincinnati Children's
name: William Brinkman, MD, MEd, MSc
role: PRINCIPAL_INVESTIGATOR
References: