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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487967
• Other study ID #: 11-008315
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: July 19, 2016
• Start date: January 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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).

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Treatment Acceptability	Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).	Baseline, after 3 months, after 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No