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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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).
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
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.
Time frame: Up to 24 months
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
Time frame: Baseline
Treatment Acceptability
Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline, after 3 months, after 6 months
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Goal Attainment
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
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.
Time frame: Up to 24 months