Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Other: Preference and Goal Instrument
- Registration Number
- NCT01487967
- Lead Sponsor
- Children's Hospital of Philadelphia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- All interested non-trainee clinicians at study sites
- Parents/legal guardians of children age 6-12, in K-6 grade, diagnosed with ADHD.
- child diagnosed with autism or a psychotic disorder
- parents non-English speaking
- parents unable to provide consent
- pediatric residents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Preference and Goal Instrument 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 Measures
Name Time Method Feasibility of family recruitment and follow-up 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.
- Secondary Outcome Measures
Name Time Method Parent Engagement Up to 24 months 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
Clinical Outcomes Baseline, after 3 months, after 6 months Change in symptom severity, measured by the Vanderbilt scale over time Change in functional impairment, measured by the Columbia Impairment Scale (CIS), over time
Acceptability of the intervention to parents and clinicians Up to 24 months 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.
Joint Participation in Decision-Making and Partnership Baseline 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 madeTreatment Acceptability Baseline, after 3 months, after 6 months Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).
Treatment Adherence/Receipt Up to 24 months 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.
Goal Attainment after 3 months, after 6 months Parents will identify goals at the study start, and progress toward meeting those goals will be tracked during the study.
Trial Locations
- Locations (1)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States