Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preference and Goal-Directed Primary Care to Minimize Disparities and Improve Outcomes in ADHD

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Other: Preference and Goal Instrument


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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). | Other: Preference and Goal Instrument<br>* 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).<br>|
| No Intervention: Control<br>Parents will receive education on ADHD and its treatment, and otherwise receive standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline | 
| Treatment Acceptability | Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P). | 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 | 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. | 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 | 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. | 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. | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Hyperactivity Disorder, ADHD, Preferences, Goals, Decision Making