Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study
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.
Attention Deficit Hyperactivity Disorder
Other: Preference and Goal Instrument
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preference and Goal-Directed Primary Care to Minimize Disparities and Improve Outcomes in ADHD|
- Feasibility of family recruitment and follow-up [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]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.
- Joint Participation in Decision-Making and Partnership [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, after 3 months, after 6 months ] [ Designated as safety issue: No ]Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).
- Parent Engagement [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]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 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, after 3 months, after 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: after 3 months, after 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Other: Preference and Goal Instrument
Clinicians will receive training on the updated AAP guidelines for ADHD, and receive training on the preference and goal instrument and on directing care toward preferences and goals.
Parents will receive education on ADHD and its treatment, and on the preference and goal instrument, will complete the preference and goal instrument, use it in the ADHD treatment decision-making process, and have preferences and goals tracked over time.
No Intervention: Control
Clinicians will receive training on the updated American Academy of Pediatrics (AAP) guidelines for ADHD.
Parents will receive education on ADHD and its treatment, and otherwise receive standard care.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487967
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|