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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: Preference and Goal Instrument

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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).
No Intervention: Control; Parents will receive education on ADHD and its treatment, and otherwise receive standard care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Alexander G Fiks, MD, MSCE, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 5, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: ADHD; Decision Making; Attention Deficit Hyperactivity Disorder; Preferences; Goals
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 11-008315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO