New Technologies to Help Manage ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Developing New Technologies to Improve ADHD Medication Continuity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390791
• Other study ID #: R34MH101155
• Secondary ID: R34MH101155
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2019
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Other:
• 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
• treatment as usual standard portal
Standard version of myADHDportal.com web software

Locations

Country	Name	City	State
United States	William B Brinkman	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 months after starting treatment
Secondary	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	6 months after starting treatment
Secondary	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)	6 months after starting treatment
Secondary	Working Alliance Inventory	range 12-60, higher scores better (more alliance)	6 months after starting treatment
Secondary	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)	6 months after starting treatment
Secondary	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)	6 months after starting treatment
Secondary	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	6 months after starting treatment
Secondary	Total Number of myADHDportal.Com Log-ins by Parent		6 months after starting treatment
Secondary	Total Number of Measures Completed by Parents to Track Child Response to Treatment		6 months after starting treatment