Attention Deficit Hyperactivity DisorderNCT01487967
Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study
A study testing Preference and Goal Instrument in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This pilot intervention study will test the feasibility and acceptability and explore the outcomes of an urban, primary care-based intervention to measure families' preferences and goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical care to reach these goals. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Preference and Goal Instrument
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2016
- 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
- No healthy volunteers
- Child
Who may be able to join
- All interested non-trainee clinicians at study sites
- Parents/legal guardians of children age 6-12, in K-6 grade, diagnosed with ADHD.
Who cannot join
- child diagnosed with autism or a psychotic disorder
- parents non-English speaking
- parents unable to provide consent
- pediatric residents
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Preference and Goal-Directed Primary Care to Minimize Disparities and Improve Outcomes in ADHD
This pilot intervention study will test the feasibility and acceptability and explore the outcomes of an urban, primary care-based intervention to measure families' preferences and goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical care to reach these goals.
Read the detailed description
The intervention includes provision of enhanced, culturally appropriate education about ADHD and its treatment, completion of a validated preference and goal instrument, use of this instrument in the ADHD treatment decision-making process, and tracking of preferences and goals over time.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Preference and Goal Instrument
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Preferences, Goals, Decision Making
- 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.
Preference and Goal InstrumentOther
Families in the intervention arm will receive culturally appropriate educational material, complete the Preference and Goal Instrument at the study start, use the results to inform decision making about ADHD treatment, have their preferences/goals tracked in the electronic health record, and have their progress toward their goals assessed at 3 months and 6 months (approximately).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Families in the intervention arm will receive culturally appropriate educational material, complete the Preference and Goal Instrument at the study start, use the results to inform decision making about ADHD treatment, have their preferences/goals tracked in the electronic health record, and have their progress toward their goals assessed at 3 months and 6 months (approximately). Receives: Other: Preference and Goal Instrument |
| Control | No intervention | Parents will receive education on ADHD and its treatment, and otherwise receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of family recruitment and follow-up
The feasibility of this intervention will be assessed by examining the proportion of families screened that meet enrollment criteria, the proportion meeting enrollment criteria that enroll, and the proportion enrolled that complete each study measure.
Measured: Up to 24 months
Secondary outcomes (7)
Joint Participation in Decision-Making and Partnership
Participation in decision-making, measured by the Observing Patient Involvement (OPTION) scale.
Patient partnership, measured by the Patient Participation in Care Scale score after the initial visit at which ADHD treatment decisions are made
Measured: Baseline
Treatment Acceptability
Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).
Measured: Baseline, after 3 months, after 6 months
Parent Engagement
Engagement will be measured by the number of primary care visits and number of primary care phone calls over the course of the study period
Measured: Up to 24 months
Treatment Adherence/Receipt
Treatment adherence/receipt measured by the number of mental health visits, number of medication refills, and length of time taken to reach a stable treatment dose.
Measured: Up to 24 months
Clinical Outcomes
Change in symptom severity, measured by the Vanderbilt scale over time Change in functional impairment, measured by the Columbia Impairment Scale (CIS), over time
Measured: Baseline, after 3 months, after 6 months
Goal Attainment
Parents will identify goals at the study start, and progress toward meeting those goals will be tracked during the study.
Measured: after 3 months, after 6 months
Acceptability of the intervention to parents and clinicians
Satisfaction with the intervention will be assessed by parent and clinician responses to open-ended questions about satisfaction, acceptability and unintended consequences of the intervention.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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 Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487967
- Sponsor's protocol ID
- 11-008315
- Status last verified
- Jul 2016
- First submitted
- 5 Dec 2011
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference and Goal-Directed Primary Care to Minimize Disparities and Improve Outcomes in ADHD
- ClinicalTrials.gov ID
- NCT01487967
- Acronym / sponsor ID
- 11-008315
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Preferences, Goals, Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Dec 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.
This pilot intervention study will test the feasibility and acceptability and explore the outcomes of an urban, primary care-based intervention to measure families' preferences and goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical care to reach these goals.
Detailed description
The intervention includes provision of enhanced, culturally appropriate education about ADHD and its treatment, completion of a validated preference and goal instrument, use of this instrument in the ADHD treatment decision-making process, and tracking of preferences and goals over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Preference and Goal InstrumentFamilies in the intervention arm will receive culturally appropriate educational material, complete the Preference and Goal Instrument at the study start, use the results to inform decision making about ADHD treatment, have their preferences/goals tracked in the electronic health record, and have their progress toward their goals assessed at 3 months and 6 months (approximately). |
| Control | No intervention | –Parents will receive education on ADHD and its treatment, and otherwise receive standard care. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All interested non-trainee clinicians at study sites
- Parents/legal guardians of children age 6-12, in K-6 grade, diagnosed with ADHD.
Key exclusion criteria (4 listed)
- child diagnosed with autism or a psychotic disorder
- parents non-English speaking
- parents unable to provide consent
- pediatric residents
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 |
|---|---|---|
| Preference and Goal InstrumentFamilies in the intervention arm will receive culturally appropriate educational material, complete the Preference and Goal Instrument at the study start, use the results to inform decision making about ADHD treatment, have their preferences/goals tracked in the electronic health record, and have their progress toward their goals assessed at 3 months and 6 months (approximately). | Other | Intervention |
Primary outcome
Feasibility of family recruitment and follow-up
Time frame: Up to 24 months
The feasibility of this intervention will be assessed by examining the proportion of families screened that meet enrollment criteria, the proportion meeting enrollment criteria that enroll, and the proportion enrolled that complete each study measure.
7 secondary outcomes
Joint Participation in Decision-Making and Partnership
Time frame: Baseline
Treatment Acceptability
Time frame: Baseline, after 3 months, after 6 months
Parent Engagement
Time frame: Up to 24 months
Treatment Adherence/Receipt
Time frame: Up to 24 months
Clinical Outcomes
Time frame: Baseline, after 3 months, after 6 months
Goal Attainment
Time frame: after 3 months, after 6 months
Acceptability of the intervention to parents and clinicians
Time frame: Up to 24 months
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 21 Jul 2016.
- 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.
Alexander G Fiks, MD, MSCE 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 Preference and Goal Instrument 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 4 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 21 Jul 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?
Feasibility of family recruitment and follow-up (time frame: Up to 24 months). 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 21 Jul 2016.