Attention Deficit/Hyperactivity DisorderNCT01275378
Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder
A study testing Collaborative Care Plus and Traditional Collaborative Care in people with Attention Deficit/Hyperactivity Disorder, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two care models on ADHD outcomes: one, a model of basic care management and structured communication with specialists, consistent with conventional descriptions of a patient-centered Medical Home; and another, which combines the Medical Home with… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- What is being tested?
- Collaborative Care Plus and Traditional Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is being evaluated for a potential diagnosis of ADHD by a primary care pediatrician at one of our sites.
- Child is 6 to 12 years of age
- Family plans to remain in the Boston area for the duration of the follow-up period
- Mother is comfortable in English or Spanish
Who cannot join
- Child already has a confirmed diagnosis of ADHD
- Child already receives ongoing specialty care in one or more of the following clinics: pediatric psychiatry, developmental behavioral pediatrics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARATIVE EFFECTIVENESS RESEARCH FOR TWO MEDICAL HOME MODELS FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER
The purpose of this study is to compare the effectiveness of two care models on ADHD outcomes: one, a model of basic care management and structured communication with specialists, consistent with conventional descriptions of a patient-centered Medical Home; and another, which combines the Medical Home with theory-based care management strategies to address common reasons for ADHD treatment failure.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Being tested
- Collaborative Care Plus, Traditional Collaborative Care
- 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.
Collaborative Care PlusBehavioural
Traditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans
Traditional Collaborative CareBehavioural
Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care Plus | Active comparator | Collaborative care model with specific theory-based elements to address common reasons for ADHD treatment failure Receives: Behavioral: Collaborative Care Plus |
| Traditional Collaborative Care | Active comparator | Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists Receives: Behavioral: Traditional Collaborative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Symptoms
Swanson, Nolan and Pelham scale (SNAP-IV)
Measured: 6 mo
ADHD Symptoms
Swanson, Nolan and Pelham scale (SNAP-IV)
Measured: 12 mo
Patient Medication Adherence
Timely prescribed refills of ADHD medications - assessed through the EHR - will provide an accurate picture of medication adherence from the perspective of prescription writing. In addition, we will administer the validated Medication Adherence Scale, which has good reliability among parents of urban children with asthma
Measured: 6 mo
Patient Medication Adherence
Timely prescribed refills of ADHD medications - assessed through the EHR - will provide an accurate picture of medication adherence from the perspective of prescription writing. In addition, we will administer the validated Medication Adherence Scale, which has good reliability among parents of urban children with asthma
Measured: 12 mo
Secondary outcomes (5)
ODD Symptoms
SNAP-IV
Measured: 6 mo
Social Skills
Social Skills Rating System
Measured: 6 mo
Time to Symptom Improvement
Based on follow-up ADHD symptom scales administered at regular intervals by our care managers, we will quantify the time between initial diagnosis and definitive improvement - conventionally defined by a 25% symptom reduction from baseline
Measured: 12 mo
ODD Symptoms
SNAP-IV
Measured: 12 mo
Social Skills
Social Skills Rating System
Measured: 12 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Codman Square Health Center, Dorchester House Health Center
- Responsible party
- Principal investigator, Michael Silverstein, Boston Medical Center
- Investigators
- Michael Silverstein, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275378
- Sponsor's protocol ID
- R40MC17181
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2010
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Silverstein M, Hironaka LK, Walter HJ, Feinberg E, Sandler J, Pellicer M, Chen N, Cabral H. Collaborative care for children with ADHD symptoms: a randomized comparative effectiveness trial. Pediatrics. 2015 Apr;135(4):e858-67. doi: 10.1542/peds.2014-3221.
PubMed 25802346
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE EFFECTIVENESS RESEARCH FOR TWO MEDICAL HOME MODELS FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER
- ClinicalTrials.gov ID
- NCT01275378
- Acronym / sponsor ID
- R40MC17181
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Codman Square Health Center, Dorchester House Health Center
- Study start
- Oct 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of two care models on ADHD outcomes: one, a model of basic care management and structured communication with specialists, consistent with conventional descriptions of a patient-centered Medical Home; and another, which combines the Medical Home with theory-based care management strategies to address common reasons for ADHD treatment failure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care Plus | Active comparator | Behavioral: Collaborative Care PlusCollaborative care model with specific theory-based elements to address common reasons for ADHD treatment failure |
| Traditional Collaborative Care | Active comparator | Behavioral: Traditional Collaborative CareTraditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child is being evaluated for a potential diagnosis of ADHD by a primary care pediatrician at one of our sites.
- Child is 6 to 12 years of age
- Family plans to remain in the Boston area for the duration of the follow-up period
- Mother is comfortable in English or Spanish
Key exclusion criteria (2 listed)
- Child already has a confirmed diagnosis of ADHD
- Child already receives ongoing specialty care in one or more of the following clinics: pediatric psychiatry, developmental behavioral pediatrics
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 |
|---|---|---|
| Collaborative Care PlusTraditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans | Behavioural | Collaborative Care Plus |
| Traditional Collaborative CareTraditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists | Behavioural | Traditional Collaborative Care |
Primary outcome
ADHD Symptoms
Time frame: 6 mo
Swanson, Nolan and Pelham scale (SNAP-IV)
ADHD Symptoms
Time frame: 12 mo
Swanson, Nolan and Pelham scale (SNAP-IV)
Patient Medication Adherence
Time frame: 6 mo
Timely prescribed refills of ADHD medications - assessed through the EHR - will provide an accurate picture of medication adherence from the perspective of prescription writing. In addition, we will administer the validated Medication Adherence Scale, which has good reliability among parents of urban children with asthma
Patient Medication Adherence
Time frame: 12 mo
Timely prescribed refills of ADHD medications - assessed through the EHR - will provide an accurate picture of medication adherence from the perspective of prescription writing. In addition, we will administer the validated Medication Adherence Scale, which has good reliability among parents of urban children with asthma
5 secondary outcomes
ODD Symptoms
Time frame: 6 mo
Social Skills
Time frame: 6 mo
Time to Symptom Improvement
Time frame: 12 mo
ODD Symptoms
Time frame: 12 mo
Social Skills
Time frame: 12 mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Derived from this study: PubMed 25802346Silverstein M, Hironaka LK, Walter HJ, Feinberg E, Sandler J, Pellicer M, Chen N, Cabral H. Collaborative care for children with ADHD symptoms: a randomized comparative effectiveness trial. Pediatrics. 2015 Apr;135(4):e858-67. doi: 10.1542/peds.2014-3221.
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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.
Michael Silverstein, MD, MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care Plus and Traditional Collaborative Care in people with Attention Deficit/Hyperactivity Disorder, run by Boston Medical Center 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 4 inclusion and 2 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 10 Oct 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ADHD Symptoms (time frame: 6 mo). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275378, which also lists 1 linked publication.
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 10 Oct 2016.