Attention Deficit Hyperactivity DisorderNCT02271386
Educating and Supporting Primary Care Providers in the Implementation of Evidence-based Practices for ADHD
A study testing Supporting Practice for ADHD (SPA) in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Although numerous studies have demonstrated that a high percentage of primary care providers (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing ADHD, many fail to implement these guidelines correctly. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Supporting Practice for ADHD (SPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 895 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 31 Jul 2016
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Non-resident clinician (physician or nurse practitioner) at participating site
- Children aged 5-12 years receiving care from a clinician enrolled in the study for ADHD and their parents
Who cannot join
- Residents
- Secondary Subjects: Families
- Autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19103
About this study
Although numerous studies have demonstrated that a high percentage of primary care providers (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing ADHD, many fail to implement these guidelines correctly. The goal of this project is to increase the use of evidence-based practices (EBP) for assessing and treating children with ADHD between 5 and 12 years in the context of primary care practice. This randomized controlled trial will evaluate the whether a 3-part intervention (education about ADHD management and communication training, collaborative consultation, and performance feedback regarding use of EBPs) is effective in improving EBP use among primary care providers.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Supporting Practice for ADHD (SPA)
- Keywords
- Evidence-Based Practice, Provider Education
- 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.
Supporting Practice for ADHD (SPA)Behavioural
The SPA intervention will last for 8 months for each study arm (first 8 months of the study for the intervention group, last 8 months for the control group). The intervention includes 3 components: 1) a series of web-based educational presentations to provide education to providers about evidence-based practice for managing ADHD and strategies for promoting effective communication with families 2) Collaborative consultation designed to address clinical issues arising in practice will be provided by members of the study team.
- Providers will be given systematic performance feedback with regard to their use of evidence-based practices for ADHD every 2 months during the 8-month intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Clinicians in the intervention arm will receive the three-part intervention (Supporting Practice for ADHD, or SPA) which includes: education about ADHD management and communication training, collaborative consultation, and performance feedback, for the first 8 months of the study. Receives: Behavioral: Supporting Practice for ADHD (SPA) |
| Control | Other | Clinicians in the control arm will receive no intervention for the first 8 months of the study, then will receive the full SPA intervention for the last 8 months of the study. Receives: Behavioral: Supporting Practice for ADHD (SPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Were Sent the Parents Rating Scale
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the baseline interval
Measured: Baseline Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the baseline interval
Measured: Baseline Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the baseline interval
Measured: Baseline Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the baseline interval
Measured: Baseline Period (8 months)
Number of Patients Who Were Sent the Parents Rating Scale
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the intervention interval
Measured: Intervention Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the intervention interval
Measured: Intervention Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the intervention interval
Measured: Intervention Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the intervention interval
Measured: Intervention Period (8 months)
Secondary outcomes (20)
Number of Patients Who Were Sent the Parent Rating Scale - by MOC Status
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Measured: Baseline Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Measured: Baseline Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Measured: Baseline Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Measured: Baseline Period (8 months)
Number of Patients Who Were Sent the Parent Rating Scale- by MOC Status
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Measured: Intervention Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Measured: Intervention Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Measured: Intervention Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Measured: Intervention Period (8 months)
Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Measured: Baseline Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Measured: Baseline Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Measured: Baseline Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Measured: Baseline Period (8 months)
Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Measured: Intervention Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Measured: Intervention Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Measured: Intervention Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Measured: Intervention Period (8 months)
Implementation Outcome: Number of Clinicians Who Completed All 3 Educational Presentations
We assessed the proportion of clinicians randomized to the intervention group that completed all 3 educational presentations.
Measured: Intervention Period (8 months)
Implementation Outcome: Number of Clinicians Who Used the Collaborative Consultation Component
We calculated the proportion of clinicians in the intervention group that posted in the online networking site which was used to facilitate collaborative consultation.
Measured: Intervention Period (8 months)
Implementation Outcome: Number of Clinicians Who Participated in at Least One Performance Feedback Call
We calculated the proportion of clinicians in the intervention group who participated in at least one of the four performance feedback calls that were held during the study period.
Measured: Intervention Period (8 months)
Implementation Outcome: Number of Clinicians Who Participated in All Intervention Components and Attested to Fulfilling MOC Requirements
We calculated the proportion of clinicians in the intervention group who completed all components of the intervention and attested to fulfilling MOC requirements.
Measured: Intervention Period (8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2014
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
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.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 895 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander G Fiks, MD, MSCE, Principal investigator, Children's Hospital of PhiladelphiaThomas Power, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271386
- Sponsor's protocol ID
- 14-011189
- Status last verified
- Mar 2019
- First submitted
- 13 Oct 2014
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educating and Supporting Primary Care Providers in the Implementation of Evidence-based Practices for ADHD
- ClinicalTrials.gov ID
- NCT02271386
- Acronym / sponsor ID
- 14-011189
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Evidence-Based Practice, Provider Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 895 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 18 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although numerous studies have demonstrated that a high percentage of primary care providers (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing ADHD, many fail to implement these guidelines correctly. The goal of this project is to increase the use of evidence-based practices (EBP) for assessing and treating children with ADHD between 5 and 12 years in the context of primary care practice. This randomized controlled trial will evaluate the whether a 3-part intervention (education about ADHD management and communication training, collaborative consultation, and performance feedback regarding use of EBPs) is effective in improving EBP use among primary care providers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Supporting Practice for ADHD (SPA)Clinicians in the intervention arm will receive the three-part intervention (Supporting Practice for ADHD, or SPA) which includes: education about ADHD management and communication training, collaborative consultation, and performance feedback, for the first 8 months of the study. |
| Control | Other | Behavioral: Supporting Practice for ADHD (SPA)Clinicians in the control arm will receive no intervention for the first 8 months of the study, then will receive the full SPA intervention for the last 8 months of the study. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Non-resident clinician (physician or nurse practitioner) at participating site
- Children aged 5-12 years receiving care from a clinician enrolled in the study for ADHD and their parents
Key exclusion criteria (3 listed)
- Residents
- Secondary Subjects: Families
- Autism spectrum disorder
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 |
|---|---|---|
| Supporting Practice for ADHD (SPA)The SPA intervention will last for 8 months for each study arm (first 8 months of the study for the intervention group, last 8 months for the control group). The intervention includes 3 components: 1) a series of web-based educational presentations to provide education to providers about evidence-based practice for managing ADHD and strategies for promoting effective communication with families 2) Collaborative consultation designed to address clinical issues arising in practice will be provided by members of the study team. 3) Providers will be given systematic performance feedback with regard to their use of evidence-based practices for ADHD every 2 months during the 8-month intervention period. | Behavioural | Control, Intervention |
Primary outcome
Number of Patients Who Were Sent the Parents Rating Scale
Time frame: Baseline Period (8 months)
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the baseline interval
Number of Patients Whose Parent Rating Scale Was Returned
Time frame: Baseline Period (8 months)
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the baseline interval
Number of Patients Who Were Sent the Teacher Rating Scale
Time frame: Baseline Period (8 months)
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the baseline interval
Number of Patients Whose Teacher Rating Scale Was Returned
Time frame: Baseline Period (8 months)
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the baseline interval
Number of Patients Who Were Sent the Parents Rating Scale
Time frame: Intervention Period (8 months)
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the intervention interval
Number of Patients Whose Parent Rating Scale Was Returned
Time frame: Intervention Period (8 months)
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the intervention interval
Number of Patients Who Were Sent the Teacher Rating Scale
Time frame: Intervention Period (8 months)
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the intervention interval
Number of Patients Whose Teacher Rating Scale Was Returned
Time frame: Intervention Period (8 months)
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the intervention interval
20 secondary outcomes
Number of Patients Who Were Sent the Parent Rating Scale - by MOC Status
Time frame: Baseline Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status
Time frame: Baseline Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status
Time frame: Baseline Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status
Time frame: Baseline Period (8 months)
Number of Patients Who Were Sent the Parent Rating Scale- by MOC Status
Time frame: Intervention Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status
Time frame: Intervention Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status
Time frame: Intervention Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status
Time frame: Intervention Period (8 months)
Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation
Time frame: Baseline Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation
Time frame: Baseline Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation
Time frame: Baseline Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation
Time frame: Baseline Period (8 months)
Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation
Time frame: Intervention Period (8 months)
Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation
Time frame: Intervention Period (8 months)
Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation
Time frame: Intervention Period (8 months)
Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation
Time frame: Intervention Period (8 months)
Implementation Outcome: Number of Clinicians Who Completed All 3 Educational Presentations
Time frame: Intervention Period (8 months)
Implementation Outcome: Number of Clinicians Who Used the Collaborative Consultation Component
Time frame: Intervention Period (8 months)
Implementation Outcome: Number of Clinicians Who Participated in at Least One Performance Feedback Call
Time frame: Intervention Period (8 months)
Implementation Outcome: Number of Clinicians Who Participated in All Intervention Components and Attested to Fulfilling MOC Requirements
Time frame: Intervention Period (8 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alexander G Fiks, MD, MSCE principal investigator
Children's Hospital of Philadelphia
Thomas Power, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supporting Practice for ADHD (SPA) in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Philadelphia 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 2 inclusion and 3 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 18 Mar 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 18 Mar 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?
Number of Patients Who Were Sent the Parents Rating Scale (time frame: Baseline Period (8 months)). The study lists 8 primary outcomes in all. 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 18 Mar 2019.