Back to resultsPreference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preference and Goal Instrument
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, ADHD, Preferences, Goals, Decision Making
Eligibility Criteria
Inclusion Criteria:
- All interested non-trainee clinicians at study sites
- Parents/legal guardians of children age 6-12, in K-6 grade, diagnosed with ADHD.
Exclusion Criteria:
- child diagnosed with autism or a psychotic disorder
- parents non-English speaking
- parents unable to provide consent
- pediatric residents
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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).
Parents will receive education on ADHD and its treatment, and otherwise receive standard care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Treatment Acceptability
Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).
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
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.
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
Goal Attainment
Parents will identify goals at the study start, and progress toward meeting those goals will be tracked during the study.
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.
Full Information
NCT ID
NCT01487967
First Posted
December 5, 2011
Last Updated
July 19, 2016
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT01487967
Brief Title
Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study
Official Title
Preference and Goal-Directed Primary Care to Minimize Disparities and Improve Outcomes in ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, ADHD, Preferences, Goals, Decision Making
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Parents will receive education on ADHD and its treatment, and otherwise receive standard care.
Intervention Type
Other
Intervention Name(s)
Preference and Goal Instrument
Intervention Description
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).
Primary Outcome Measure Information:
Title
Feasibility of family recruitment and follow-up
Description
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.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Joint Participation in Decision-Making and Partnership
Description
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
Time Frame
Baseline
Title
Treatment Acceptability
Description
Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).
Time Frame
Baseline, after 3 months, after 6 months
Title
Parent Engagement
Description
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
Time Frame
Up to 24 months
Title
Treatment Adherence/Receipt
Description
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.
Time Frame
Up to 24 months
Title
Clinical Outcomes
Description
Change in symptom severity, measured by the Vanderbilt scale over time Change in functional impairment, measured by the Columbia Impairment Scale (CIS), over time
Time Frame
Baseline, after 3 months, after 6 months
Title
Goal Attainment
Description
Parents will identify goals at the study start, and progress toward meeting those goals will be tracked during the study.
Time Frame
after 3 months, after 6 months
Title
Acceptability of the intervention to parents and clinicians
Description
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.
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All interested non-trainee clinicians at study sites
Parents/legal guardians of children age 6-12, in K-6 grade, diagnosed with ADHD.
Exclusion Criteria:
child diagnosed with autism or a psychotic disorder
parents non-English speaking
parents unable to provide consent
pediatric residents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander G Fiks, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study
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