Attention Deficit Hyperactivity DisorderNCT02390791
New Technologies to Help Manage ADHD
A study testing enhanced myADHDportal.com and treatment as usual standard portal in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- enhanced myADHDportal.com and treatment as usual standard portal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Unable to read and speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing New Technologies to Improve ADHD Medication Continuity
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- enhanced myADHDportal.com, treatment as usual standard portal
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
treatment as usual standard portalOther
Standard version of myADHDportal.com web software
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: enhanced myADHDportal.com |
| treatment as usual standard portal | Active comparator | Standard version of myADHDportal.com web software Receives: Other: treatment as usual standard portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Continuity: The Number of Days Covered With Medicine
the number of days covered with medicine will be calculated from audit of prescriptions written
Measured: first 6 months of treatment
Secondary outcomes (9)
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
Measured: 6 months after starting treatment
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
Measured: 6 months after starting treatment
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)
Measured: 6 months after starting treatment
Working Alliance Inventory
range 12-60, higher scores better (more alliance)
Measured: 6 months after starting treatment
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)
Measured: 6 months after starting treatment
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)
Measured: 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
Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale
Measured: 6 months after starting treatment
Total Number of myADHDportal.Com Log-ins by Parent
Measured: 6 months after starting treatment
Total Number of Measures Completed by Parents to Track Child Response to Treatment
Measured: 6 months after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- William Brinkman, MD, MEd, MSc, Principal investigator, Cincinnati Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390791
- Sponsor's protocol ID
- R34MH101155
- Other IDs
- R34MH101155
- Status last verified
- Aug 2019
- First submitted
- 4 Mar 2015
- Last updated
- 13 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing New Technologies to Improve ADHD Medication Continuity
- ClinicalTrials.gov ID
- NCT02390791
- Acronym / sponsor ID
- R34MH101155
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enhanced myADHDportal.com | Experimental | Other: enhanced myADHDportal.comVersion 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 | Active comparator | Other: treatment as usual standard portalStandard version of myADHDportal.com web software |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parents of children are eligible to participate if
Key exclusion criteria (1 listed)
- Unable to read and speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced myADHDportal.comVersion 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 portalStandard version of myADHDportal.com web software | Other | treatment as usual standard portal |
Primary outcome
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
9 secondary outcomes
Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale)
Time frame: 6 months after starting treatment
Parent-reported Decisional Conflict (Decisional Conflict Scale)
Time frame: 6 months after starting treatment
Parent Trust in Provider (Trust in Provider Scale)
Time frame: 6 months after starting treatment
Working Alliance Inventory
Time frame: 6 months after starting treatment
Parent Perceived Social Support (Perceived Social Support Scale)
Time frame: 6 months after starting treatment
Parent Distress (Parenting Stress Index - Short Form)
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
Time frame: 6 months after starting treatment
Total Number of myADHDportal.Com Log-ins by Parent
Time frame: 6 months after starting treatment
Total Number of Measures Completed by Parents to Track Child Response to Treatment
Time frame: 6 months after starting treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Brinkman, MD, MEd, MSc principal investigator
Cincinnati Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced myADHDportal.com and treatment as usual standard portal in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Continuity: The Number of Days Covered With Medicine (time frame: first 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.